510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Siemens Gammasonics, Inc.

Mchenry, IL, US

Siemens Gammasonics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 53 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
53
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 53

FDA records hold 53 510(k) clearances for Siemens Gammasonics, Inc. between 1981 and 1994. The busiest year on record is 1991, with 11. The most recent is 1994, with 1.

Clearances by year, as a table
510(k) clearance decisions for Siemens Gammasonics, Inc., by decision year
YearClearances
19815
19821
19832
19842
19852
19864
19873
19883
19896
19905
199111
19926
19932
19941
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K934766CARBON FIBER PALLETIYXSubstantially Equivalent
K933664POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)IZISubstantially Equivalent
K933256FAN BEAM COLLIMATORIYXSubstantially Equivalent
K920319SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITILLZSubstantially Equivalent
K923582SIENET CAMERA SERVERLMDSubstantially Equivalent
K922373MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEMKPSSubstantially Equivalent
K922372MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEMKPSSubstantially Equivalent
K920310SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVELMDSubstantially Equivalent
K920309SIENET DIAGNOSTIC REPORTING CONSOLELLZSubstantially Equivalent
K914313HICORIZISubstantially Equivalent
K914350ICON COMPUTER SYSTEMJWMSubstantially Equivalent
K914179CARDIOFOCAL COLLIMATORKPSSubstantially Equivalent
K913630MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEMKPSSubstantially Equivalent
K913252LITEBOXJAKSubstantially Equivalent
K912481ECT CARBON FIBER PALLET, MODIFICATIONIYZSubstantially Equivalent
K912286CARDIAC SPECT PALLETIYZSubstantially Equivalent
K905074MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAMIYXSubstantially Equivalent
K911078MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEMKPSSubstantially Equivalent
K905199PACSNET RESEARCH TOOLKITLMDSubstantially Equivalent
K903315ICONJWMSubstantially Equivalent
K903375HICORIZISubstantially Equivalent
K903767ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PALIYZSubstantially Equivalent
K900892MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGEKPSSubstantially Equivalent
K901158LITEBOX DIAGNOSTIC REVIEW WORKSTATIONLLZSubstantially Equivalent
K901019DIACAM GAMMA CAMERA SYSTEMKPSSubstantially Equivalent
K895668DIGICAM LHP (VIDEO INTERFACE OPTION)LMCSubstantially Equivalent
K891266NEUROFOCAL COLLIMATORKPSSubstantially Equivalent
K885242MICRODELTA IIIYXSubstantially Equivalent
K884995SIEMENS PACS/1-B (OPTICAL DISK OPTION)LLZSubstantially Equivalent
K883324DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE)LMCSubstantially Equivalent
K885318DIGITRON 3, LV ANALYSIS PROTCOLLLZSubstantially Equivalent
K880690SIEMENS PACS/I-AIZISubstantially Equivalent
K881481DIGITRON STENOSIS PROTOCOLLLZSubstantially Equivalent
K883072DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEMIZISubstantially Equivalent
K871778DIGISPOT IMAGERLMCSubstantially Equivalent
K870818BODYSCANIYXSubstantially Equivalent
K861515OSTEOPAK BMD (BONE MINERAL DENSITOMETER)KGISubstantially Equivalent
K861429DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADELLZSubstantially Equivalent
K861637WEIGHTED ACQUISITION MODULEIYXSubstantially Equivalent
K861252NON-CIRCULAR ORBITING OPTIONKPSSubstantially Equivalent
K860454BASICAM S COUNTER BALANCE CAMERAIXYSubstantially Equivalent
K850463BASICAM COUNTER BALANCE CAMERAIYXSubstantially Equivalent
K850397ORBITOR II COUNTER BALANCE CAMERAIYXSubstantially Equivalent
K842895WBA - I.R.I.S.JAMSubstantially Equivalent
K841905DOT-A, DOT-AR PXP-E, PXP-ERJWMSubstantially Equivalent
K833811CARDIAC CAMERAIYXSubstantially Equivalent
K832737ECT PROCESSORJWMSubstantially Equivalent
K820124INTEGRAL SECTOR MODULEIYOSubstantially Equivalent
K811842IMAGER 2000 REAL TIME SYSTEMIYOSubstantially Equivalent
K811843BIOPSY TRANSDUCERITXSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain