2579 Assembler Report

FonnApprmd:OUBm.aO(~

FOR FDA USEONLY

~ws:~oambrsc.ams

DEPARTMENT OF HEALTH AND HUMANSERVICES

B r A u o n s ~ o w ~

FOOD AND DRUG ADMINISTRATION

REPORT OF ASSEMBLY
OF A MAGNOSTIC X-RAY SYSTEM
-.

a CQUPANY NMlE

a NMlE OF HOSPITAL DOCTOR OROFRCEWHERE INSTALLED

c CCrY

1254987-- +-

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d. STATE

1. TELEWONE NUMBER

a. ZIPWDE

1. TELEPHONE NUMBER

1

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c. CrrV

d. STATE

a ZIP CODE

-

2. ASSEM-~~EFJ
INF&WI~(~N
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1. EQUIPMENT LOCATION

.

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3. GENERAL INFORMATION
s THIS REWRTISFOR~LYOFC~RTRIEDCOMPONENTSWHICHARE
(O*drgpqrWb~m)J

b.

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m v u a w s v s tarncuaednd
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nmmtuwrn~

om u~E(s)I--(~~(w)

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[II CT WHOLE BODY WANNER

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CQNEFWPURW(IERM(OQRAPHY

PACUTION THERAWSUUUTOR

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4. COMPONENT INFORMATION (If additional space.is needsd for this section use enother form, replacing the preprinted number
with this Form Number, andcomplete I t e m 1 , 4 and 5 on&)
a T H E W E R CONTROLIS

R CONTROLMANUFACTURER

a DATE MANUFACTURED

d. CONTROLLIERULNUMBER

ANWINSTAUTION
ExmINQfWmod)

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c CONTRKMOMCNUkWKR

t. SVSTEM MaoELNAME (CT

D(ISTlNQfNcnarUsd)

C o m p b t e t h e ~ M a m e g o n f a m m W c o n p o n e n t s M W w h i a h y w ~F.o r b 6 a n K m & i n g ~ , ~ a n d C T ~ ~ t h e m a n u f p c t u r c ModelnvnkvIntheindicoted
rand

spaauForotherc4ltl*ld ~ . e n t o r l n t h e n p p m p r W b b d m h o w m e n yofeachyouinrt.lbd hthbsyebm.
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M4NUFACTURER

H O M L NUMBER

DATE MANUFACTURED

MANUFACTURER

HODUNUlBER

M E WFACTURELI

MNUFACTURER

MODEL NUMBER

DATE MANUFACTURED

0-

XdAYCOMROL

81

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r n C L R n R D C W ~
(Enftnmbnd.ldrh*.*dhqprph*m)

MANUFACTURER

MODEL NUMBER

MODELNUMBER

HDHVOLTAQEQENERATOR

ALMCHANGER

MRTICALCAS8EITEliOU)EA

WMGEINTEWRER

TUBEHOUSINGASSEMBLY

SPOT FLM DEVICE

DENTALTUBEHE40

OTHER(-,

M E MANUFACTURE0

M T E MANUFACTURED

I

5. ASSEMBLER CERTIACAlION
I afarmthatalloartifiedcompollentsmwmbledorinstallsdbyme,forwhidthiirsport kbeingmade, mweadjustedandlsrWbyme~ingtothehetruotfonspmvidedby themsnufe&~rer(s) wentd
the type requlrsd by the manutscturer(s),mve of the type requtedby the ding!m3bc x-ray pc#kmunoestandan( (21 CFR Patl1020). \were n d moditied to adversely affed perfomwar,and we* m n h e d In
accwdana,
pmvia&ls d21 CFFi Patl 1020 1a*o affirm that .
Ilnsbudan manuab and other lnkrmstkn mquimd by 21 CFR Part 1MO for thh 8ssmWy have been furnbhed ta the purchaser and,
mWn lSdaysImmthedated~,eachqdthis~wi#k,drstributed.r,hdi&atthebonanofd~.
s PRlNTED HAWE

b. SIQNATVRE

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6. COMMENTS

FORM FDA 2579 (1W )PREVIOUSEDITION

IS O B B O L ~

- FDA, HFZ-=7,2091 OIlthsr hd:R

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h e for reviewing mstructions,
m n g the @k?ctM of infa
information,including suggestions for reducing this burden to:
F:o&aRd Drug A&mme?h
Center for Devices and Raddogicel Health
1350 Piccard Dfive (HR-240)
Rockvine, IUD 2mso- -

FORM FDA.-.

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m a y n o ~ ~ o n d u c t oe ~ d~ar-,p m n i e ~ o k g q u i r e d t o
reapad €6,a c o k c t h of information unless it displays a wmntly valid
OMB conW number.'
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F r n Apparsd W B NO a3tW025

FOR FDA USE ONLY

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DEPARTMENTOF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

REPORT OF ASSEMBLY
OF A DIAGNOSTIC X-RAY SYSTEM

1. EQUIPMENT LOCATION

2. ASSEMBLER INFORMATION

a NAME OF HOSPlTW DOCTOR OROFFlCE WHERE INSTALLED

a. COMPANY NAME

b. STREET ADDRESS

b. STREETADDRESS

c. CrrY

d. STATE

1. TELEPHONE NUMBER

e. ZIPCODE

d. STATE

C.

crry

8.

ZIPCODE

1. TELEWONE NUMBER

1

(

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D 1254987

1

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3. GENERAL INFORMATION
a. THIS REPORT IS FOR ASSEMBLY OF CERTIFIEDCOMPONENTSWHICH ARE (awn*-ah,

[7
[7

bor((IP))

RU\SSEMBLYMD(ED SYSTEM (8oh~9rDJiad
and MW~-XWI#O~rOnpa?SlLs)

NMTASSWBLY-FULLY CERTIFIEDSYSTEM
RWSWBLY-FULLY CERTIFIEDSYSEU

[7
[7

AN ADDTION TO AN EXISTING SYSTEM

[7

CT WHOLE BODY SCANNER

REPLACWENT COMPONENTSIN AN EXISTINGSYSTEM

b INTENDED USE(S) ( C ? ~ e d r (Wes))
w
GENERAL PURPOSERADIOQRAPHY

[7

[7

HEAD-NECK (M)

[7

RADIATION THERAPY SIMULATOR
C-ARM FLUOROSCOPIC

CHEST

DENTAL-INTRAORAL

CHIROPRACTIC

DENTAL-CEPHALOMETRIC

WDUTW

CT HEADSCANNER

DENTAL PANORAMIC

c. THE X-RAY SYSTEM IS (a)gLme)

(71

UROLOGY
MAMMOGRAPHY

ANGlOGRAPnY

TOMOGRAPHY (Ohw#tm CT)

[7

[7

GENERAL P U R W S E F W O ~ C O P Y

[7

DIGITAL

[7

OTHER (-&

BONE MINERALANALYSIS
m mmmLs)

e DATE OFASSEMBLY

d THEMASTER CONTROLISIN ROOM

u

STATIONARY

fmflll

MOBILE

fwl

(wwf

4. COMPONENT INFORMATION (If additional space.is needed for this section use another form, replacing the preprinted number
with this Form Number, andcomplete Items 1, 4, and 5 only)
a THEMASTER CONTROLIS

[7

b. CONTROL MANUFACTURER

e. DATE MANUFACTURED

d. CONTROL SERULNUMBER

A NRN INSTALLATION

c. CONTROL MOOELNUMBER

EXISTING ( C M W )

f. SYSTEM MODELNAME (CT SysfemsOnlyJ

EXISTING (NUI-)

Complete the following n
ifor the cettified components listed below which you installed. Forbeam limiling devicas, tables and CTgantries enterthe manufacturer and Model number in the indicated
spaces. For other certified components, enter in the appropriate blocks how many of each you installed in this system.

SELECTED COIIWNWrS

9.

OTHER CERTIRED C O Y W N W r S

h.

MP.NUFACTURER

MODEL NUMBER

DATE MANUFACTURED

MANUFACTURER

MODEL NUMBER

DATE MANUFACTURED

MANUFACTURER

MODEL NUMBER

DATE MANUFACTURED

MANUFACTURER

MODEL NUMBER

DATE MANUFACTURED

(Enter nunberot wdr m
m
s
d h -LteUodrs.)

=Pa

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3

MANUFACTURER

MODEL NUMBER

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X-RAY CONTROL

CRADLE

HlGH VOLTAGE GENERATOR

FILM CHANGER

VERTICALCASS~EHOLDER

IMAGE INTENSIRER

TUBE HOUSINGASSEMBLY

SPOT FILM DEVICE

DENTALTUBE HEAD

OTHER (S~ealy)

DATE MANUFACTURED

g5

a

5. ASSEMBLER CERTIFICATION
I affimthaI all certifii componeniaasaamMedor installedby me,for which this report k being made, wereadjusted and tested by me according to Me instruclions pmvidedby the manufadurer(s).were of
the type requked by the rmmhturer(s), were of the type requiredby the diagnostic x-ray performancestandard (21 CFR Part 1020), werenat modified toadversely affect performance, and were installed in
accordance with provisions of 21 CFFI Part 1020.1 also affinn that all instructiin manu& and other infommn requ~redby21 CFR Part 1020 for this amambly haw been furnished to the purchaser and.
within 15 days from the date of assembly, each copy of this report will be distributedas indicatedat the bottom of each mpy.
a PRINTED NAME

6. COMMENTS

b. SIGNATURE

C.

DATE

r

-FORM FDA 2579 (I=) m l o w ~ o r n c mtsosw~m

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bibw Copy - State Age

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FOR FDA USE ONLY

Fam
OMBNo. 0810-W2S
~mbmoars:Decsmber31fi.~

DEPARTMENT OF HEALTH AND HUMAN SERVICES

See wrse forOMB amement

FOOD AND DRUG ADMINISTRATION

REPORT OF ASSEMBLY
OF A D I A G N ~ I cX-RAY SYSTEM

I

D 1254987

1. EQUlPMENT LOCAllON

2. ASSEMBLER INFORMATION

a NAME OF HOSPITAL, DOIXOR OROFRCE WHERE INSTALLED

a. COMPANY NAME

b. STREET ADDRESS

b. STREETADDRESS

c CITY

c. CrPl

d. STATE

<

d. STATE

-

I. TELEPHONE NUMBER

e. ZIP CODE

1. TELEPHONE NUMBER

1

(

1

(

3. GENERAL INFORMATION
a THIS REPORT IS FOR A S M E L Y OFCERTFIEO COMWNENTSWHICHARE (Chedrappop'ate baales))

RE4SSEMELYMD(EDSYSEM (5#1Cemod
eM nm-Z&Jfied
REPLACEMENTCOMPONENE IN AN MISTINGSYSTEM

RWEMBLY-FULLY CERTlFlEDSYSTEM

AN ADD1TIONTOAN MISTING SYSTEM

b. INTENDED USES). .
f-amrmn'~*~
.. .

fbmdes~~
. . ..

GENERAL PURPOSEFLUOROSCOPY
TOMOGRAPHY (Olrsrmm m)
ANGIOQRAPHY

CHIROPRACTIC

PODIATRY

CT HEADSCANNER

I c. THEX-RAY SYSTEM IS (C3eckm)

[7

C]
, , , R"
[7 MAMMOGRAPHY
C] CHEST

GENERAL PURPOSEFIADIOGFWPHY

C]

C]

NWASWBLY-FULLY CB(TIFM)SYSrEM

1

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CT WHOLE BODY SCANNER

II

RADIATION THERAPY SIMULATOR

GAFM FLUOR~SCOPIC

HEAD-NECK (Mecfid)

DIGITAL

DENTAL-INTRADRAL

U

CmIpcn~tSJ

C]

DENTAL-CEPHALOMETRIC

BONE MINERALANALYSIS
OTHER (sped+' h CUnImMW

DENTALPANORAMIC

I e. DATEOFASSRdBLY

d. THEMASTER CONTROLISIN ROOM

I I

STATIONARY

(mm)

MOBILE

fdd)

(MY)

4. COMWNENT INFORMATION (If additional space.is needed for this section use another form, replacing the preprinted number
with this Form Number, andcomplete Items 1, 4, and 5 only)
a THEMASTER CONTROLIS

[7
[7
[7

b M)NTROC MANUFACTURER

e DATE MANUFACTURED

d. CONTROL SERIALNUMBER

A N W INSTALLATION
WSTfNG(WM)

t SYSTEM MODELNAME(CTSy$WnsOn@)

c CONTROL MODELNUMBER

EXISTING (Nm-csrt@sdJ

Compfetethe foWowng ~nfmnalionforthe cemfkdcomponentslisted below whlch you installed. Forbeam Lnutrngdevices, t a b and CTgantnesenterthe manufacturer and Model number in the ~ndmted
spaces For other cartd~edcomponents,enter in the appmpnate blocks how many ofeach you mstalled In thii system.
9

SELECTED COUWNENIS

OTHER CERTlREDCOUPOt4B(TS
(Mtwnuntmroforch n W e d n c w w n a t e M c d s )

h

MANUFACTURER

MODEL NUMBER

DATE MANUFACTURED

2 5 g . MANUFACTURER

MODEL NUMBER

DATE MANUFACTURED

MANUFACTURER

MODEL NUMBER

DATE MANUFACTURED

MANUFACTURER

MODEL NUMBER

DATE MANUFACTURED

IPS

8

L

s

MANUFACTURER

MODEL NUMBER

[7

X-RAYCONTROL

CRADLE

HKjH VOLTAGEGENERATOR

nLM CHANGER

VERTICAL C4SSEITEHOLDER

IMAGE INTENSIFIER

TUBE HOUSINGASSEMBLY

SPOT FILM DEVICE

DATE MANUFACTURED
DD(TILTUBEHEAD

a

5. ASSEMBLER CERTIFICATION
I affirmthat all certified COmPOnentsassrmMed or installedby me, for which this mpolt is being made, wemadlusted and tested by me according to Me inst~dionsprovidedby the manufadumr(s), were of
the type required by the manufacturer(s),were d the type regured by the diiagnoslic x-ray pelformanmaandard (21 CFR Part 1020). werenot modified toadversely affed perfofmanw, and wem installed in
accordanca with pmvisions of 21 CFR Pan 10e0.1also aifinn that all instruction manuak and other infomtion mquired by 21 CFR Palt 1OEUfor thii assembly have been furnished to the purchaser and,
within I S days from the date of assembly, each copy of this
report will be diibuted as ndicated at the bdtom of each mpy.

a

P R I ~ D
NAME

6. COMMENTS

a

SIGNATURE

c DATE

I

1

II

II

FOR FDA USE ONLY

DEPARTMENTOF HEALTHIH) H

I

W SERVICES

FOOD AND DRUG ADMINISTRATION

I

.

MnnAppDnd:OMBNo.OMOQ125.
~ ~ ~ : a r r n b w s l , p o s
8r~k.rOMB*lnmt

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REPORT OF ASSEMRLY
OF A D I A G mM A Y SYSTEM

I. EQUIPMENT LOCATION

2. ASSEMBLER INFORMATION

r NAME OF HOSPITAL WCTOR OROFFICE WHERE INSTAlLt?D

a. COWANY NAME

r

CITY

(L

ZIPCODE

r

d. STATE

I

CITY

d STAT€

a. UP COOE

1. TELEPHONE NUMBER

I. TELEPHONE NUMBER

1

(

1

(

3. GENERAL INFO~MATION

I
I

1

r THIS REPORT ffi FOR MSB4BLY OF CERTlRED C
-

W-U

WHICH ARE (Q*c*-

[7

UROUMY

kWMOc3-Y

0(7 CHIROPRAGTK:
(7 CTH-NNER
1 d. T H E M E R CONTROLISIN RXM

(7
(7
(7
(7

CTWHOLE BODY SCANNER

RAMITION THERWYSMUUTOR

HEm+lEcKm)

GAFMFLWRXCWC

DENTALCEPHMaMETRK:

DIQITAL
BOWE MNEMLAMLYSIS
OTHER w

h

m

h

)

-

use another form, repiacing theprtprinted number
r

d. COMROLSERAINUMBER

b. CONTROLMANUMCTUAW

(7
(7

DENTAL-INT-L

4. COMPONENT INFORMATION (If addtional space.is needed for this &ion
with this Fotm Number, and compbte Item 1,4, and 5 only)
r T H E M E M CONTROLS

I

~ Y - M l X E D S Y S l E M ( ~ o M * . d r r d ~ ~ r r )

DATEMANUFACTURED

A NRWINSTAUATION
mIffi(-J

r

CONTROLMOtXLNUMBER

I

-.

mlNQ(No,-)

I

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I

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~ c O Y w n a m

0
MNUFACTURR

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unl6nCSRTIRU)CQIW)(Bm

h.

UOOELN-R

MOML NUMBfR

\
DATE MANUFACTURED

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&

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MNUFACTURER

,'

( e r c r n m 6 r d r c n ~ h ~ b l o m )

MODEL NU-

DATE MANUFACTURED

MODEL NUMEI?

DATE MANUFACTURED

HIQHWLTAQE GENERATOR

5. ASSEMBLER CERTIFICATION
I affhmm
all WMfad C o n t p M e n t s asambled insEalbdby me, for rvhkh Mls mpott in behgmede. wmadjurted and taiW by me acmrding to the hetnrctloMiprwldedby tho manufadurer(o),nsn, of
the type required by the manufaclufe#(e), wen, of ths type requLadby the dhgnostlo x-ray Wonmnm
@
CFRl
PPrt 1020), wan, nd modlRed tosdvmdy afled pmfommm, and wan, installed m
accwdance vrith prwisiamd 21 CFH Pan 1020.1aLw c d A n that a1 if&Wkm mnu& and olher Mwmrtlon mqulrsd by 21 CRI Patt 1020 for thle clsaemMy haw been furnished to tho purchaser and,
mthin 1 5 d ~ f m m ~ e d a f e a f a c l r a n b l y , e c l c h c o ~ d l h h r e p o r t \ * i l l b e d h l i r b u b s d a s M ~ r t ~ b o t t a n d ~ o o ~ .
r PRlEmD NAME

1
I

;

b. 81QNATWK

L DATE

6. COMMENTS

I
FORM FDA 2579 (12103)

WEVIOUSEDITI~

lsoesocm

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