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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
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c. CrrV
d. STATE
a ZIP CODE
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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
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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
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t. SVSTEM MaoELNAME (CT
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M4NUFACTURER
H O M L NUMBER
DATE MANUFACTURED
MANUFACTURER
HODUNUlBER
M E WFACTURELI
MNUFACTURER
MODEL NUMBER
DATE MANUFACTURED
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MANUFACTURER
MODEL NUMBER
MODELNUMBER
HDHVOLTAQEQENERATOR
ALMCHANGER
MRTICALCAS8EITEliOU)EA
WMGEINTEWRER
TUBEHOUSINGASSEMBLY
SPOT FLM DEVICE
DENTALTUBEHE40
OTHER(-,
M E MANUFACTURE0
M T E MANUFACTURED
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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 ~
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Center for Devices and Raddogicel Health
1350 Piccard Dfive (HR-240)
Rockvine, IUD 2mso- -
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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
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3. GENERAL INFORMATION
a. THIS REPORT IS FOR ASSEMBLY OF CERTIFIEDCOMPONENTSWHICH ARE (awn*-ah,
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RU\SSEMBLYMD(ED SYSTEM (8oh~9rDJiad
and MW~-XWI#O~rOnpa?SlLs)
NMTASSWBLY-FULLY CERTIFIEDSYSTEM
RWSWBLY-FULLY CERTIFIEDSYSEU
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AN ADDTION TO AN EXISTING SYSTEM
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CT WHOLE BODY SCANNER
REPLACWENT COMPONENTSIN AN EXISTINGSYSTEM
b INTENDED USE(S) ( C ? ~ e d r (Wes))
w
GENERAL PURPOSERADIOQRAPHY
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HEAD-NECK (M)
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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)
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GENERAL P U R W S E F W O ~ C O P Y
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DIGITAL
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OTHER (-&
BONE MINERALANALYSIS
m mmmLs)
e DATE OFASSEMBLY
d THEMASTER CONTROLISIN ROOM
u
STATIONARY
fmflll
MOBILE
fwl
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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
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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
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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
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FOR FDA USE ONLY
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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
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d. STATE
-
I. TELEPHONE NUMBER
e. ZIP CODE
1. TELEPHONE NUMBER
1
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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). .
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GENERAL PURPOSEFLUOROSCOPY
TOMOGRAPHY (Olrsrmm m)
ANGIOQRAPHY
CHIROPRACTIC
PODIATRY
CT HEADSCANNER
I c. THEX-RAY SYSTEM IS (C3eckm)
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GENERAL PURPOSEFIADIOGFWPHY
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NWASWBLY-FULLY CB(TIFM)SYSrEM
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RADIATION THERAPY SIMULATOR
GAFM FLUOR~SCOPIC
HEAD-NECK (Mecfid)
DIGITAL
DENTAL-INTRADRAL
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CmIpcn~tSJ
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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
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s
MANUFACTURER
MODEL NUMBER
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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.
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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
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CITY
d STAT€
a. UP COOE
1. TELEPHONE NUMBER
I. TELEPHONE NUMBER
1
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3. GENERAL INFO~MATION
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r THIS REPORT ffi FOR MSB4BLY OF CERTlRED C
-
W-U
WHICH ARE (Q*c*-
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UROUMY
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CTWHOLE BODY SCANNER
RAMITION THERWYSMUUTOR
HEm+lEcKm)
GAFMFLWRXCWC
DENTALCEPHMaMETRK:
DIQITAL
BOWE MNEMLAMLYSIS
OTHER w
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use another form, repiacing theprtprinted number
r
d. COMROLSERAINUMBER
b. CONTROLMANUMCTUAW
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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
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CONTROLMOtXLNUMBER
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MOML NUMBfR
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DATE MANUFACTURED
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MNUFACTURER
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( 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~
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File Type | application/pdf |
File Modified | 2006-11-29 |
File Created | 2006-11-15 |