Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Siemens Gammasonics, Inc. · Predicate Candidate Screening
53 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
187 days90th percentile
53clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K934766 | CARBON FIBER PALLET | Siemens Gammasonics, Inc. | 1994-02-18 | 137 | 0 |
| K933664 | POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) | Siemens Gammasonics, Inc. | 1993-12-15 | 140 | 0 |
| K933256 | FAN BEAM COLLIMATOR | Siemens Gammasonics, Inc. | 1993-10-29 | 115 | 0 |
| K920319 | SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI | Siemens Gammasonics, Inc. | 1992-10-20 | 270 | 0 |
| K923582 | SIENET CAMERA SERVER | Siemens Gammasonics, Inc. | 1992-10-14 | 86 | 0 |
| K922372 | MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM | Siemens Gammasonics, Inc. | 1992-08-17 | 89 | 0 |
| K922373 | MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM | Siemens Gammasonics, Inc. | 1992-08-17 | 89 | 0 |
| K920310 | SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE | Siemens Gammasonics, Inc. | 1992-03-30 | 67 | 1 |
| K920309 | SIENET DIAGNOSTIC REPORTING CONSOLE | Siemens Gammasonics, Inc. | 1992-03-20 | 57 | 0 |
| K914313 | HICOR | Siemens Gammasonics, Inc. | 1991-11-27 | 65 | 0 |
| K914350 | ICON COMPUTER SYSTEM | Siemens Gammasonics, Inc. | 1991-11-22 | 56 | 1 |
| K914179 | CARDIOFOCAL COLLIMATOR | Siemens Gammasonics, Inc. | 1991-10-30 | 42 | 0 |
| K913630 | MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM | Siemens Gammasonics, Inc. | 1991-10-23 | 69 | 0 |
| K913252 | LITEBOX | Siemens Gammasonics, Inc. | 1991-08-26 | 35 | 0 |
| K912481 | ECT CARBON FIBER PALLET, MODIFICATION | Siemens Gammasonics, Inc. | 1991-08-02 | 71 | 0 |
| K912286 | CARDIAC SPECT PALLET | Siemens Gammasonics, Inc. | 1991-08-02 | 71 | 0 |
| K905074 | MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM | Siemens Gammasonics, Inc. | 1991-06-21 | 224 | 0 |
| K911078 | MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM | Siemens Gammasonics, Inc. | 1991-06-17 | 98 | 0 |
| K905199 | PACSNET RESEARCH TOOLKIT | Siemens Gammasonics, Inc. | 1991-01-14 | 55 | 0 |
| K903315 | ICON | Siemens Gammasonics, Inc. | 1991-01-09 | 169 | 1 |
| K903375 | HICOR | Siemens Gammasonics, Inc. | 1990-10-01 | 67 | 0 |
| K903767 | ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL | Siemens Gammasonics, Inc. | 1990-09-07 | 18 | 0 |
| K900892 | MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE | Siemens Gammasonics, Inc. | 1990-05-02 | 64 | 0 |
| K901158 | LITEBOX DIAGNOSTIC REVIEW WORKSTATION | Siemens Gammasonics, Inc. | 1990-04-19 | 37 | 0 |
| K901019 | DIACAM GAMMA CAMERA SYSTEM | Siemens Gammasonics, Inc. | 1990-04-04 | 29 | 0 |
| K895668 | DIGICAM LHP (VIDEO INTERFACE OPTION) | Siemens Gammasonics, Inc. | 1989-11-15 | 56 | 0 |
| K891266 | NEUROFOCAL COLLIMATOR | Siemens Gammasonics, Inc. | 1989-04-17 | 40 | 0 |
| K885242 | MICRODELTA II | Siemens Gammasonics, Inc. | 1989-03-30 | 98 | 0 |
| K884995 | SIEMENS PACS/1-B (OPTICAL DISK OPTION) | Siemens Gammasonics, Inc. | 1989-02-28 | 89 | 0 |
| K883324 | DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE) | Siemens Gammasonics, Inc. | 1989-02-27 | 206 | 0 |
| K885318 | DIGITRON 3, LV ANALYSIS PROTCOL | Siemens Gammasonics, Inc. | 1989-02-17 | 49 | 0 |
| K880690 | SIEMENS PACS/I-A | Siemens Gammasonics, Inc. | 1988-10-31 | 252 | 0 |
| K881481 | DIGITRON STENOSIS PROTOCOL | Siemens Gammasonics, Inc. | 1988-10-12 | 187 | 0 |
| K883072 | DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM | Siemens Gammasonics, Inc. | 1988-09-14 | 56 | 0 |
| K871778 | DIGISPOT IMAGER | Siemens Gammasonics, Inc. | 1987-05-29 | 23 | 0 |
| K870818 | BODYSCAN | Siemens Gammasonics, Inc. | 1987-03-16 | 13 | 0 |
| K861515 | OSTEOPAK BMD (BONE MINERAL DENSITOMETER) | Siemens Gammasonics, Inc. | 1987-02-02 | 285 | 0 |
| K861429 | DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE | Siemens Gammasonics, Inc. | 1986-07-25 | 100 | 0 |
| K861637 | WEIGHTED ACQUISITION MODULE | Siemens Gammasonics, Inc. | 1986-06-10 | 41 | 0 |
| K861252 | NON-CIRCULAR ORBITING OPTION | Siemens Gammasonics, Inc. | 1986-04-16 | 13 | 0 |
| K860454 | BASICAM S COUNTER BALANCE CAMERA | Siemens Gammasonics, Inc. | 1986-02-21 | 16 | 0 |
| K850463 | BASICAM COUNTER BALANCE CAMERA | Siemens Gammasonics, Inc. | 1985-04-10 | 63 | 0 |
| K850397 | ORBITOR II COUNTER BALANCE CAMERA | Siemens Gammasonics, Inc. | 1985-03-26 | 53 | 1 |
| K842895 | WBA - I.R.I.S. | Siemens Gammasonics, Inc. | 1984-08-27 | 35 | 0 |
| K841905 | DOT-A, DOT-AR PXP-E, PXP-ER | Siemens Gammasonics, Inc. | 1984-08-09 | 94 | 0 |
| K833811 | CARDIAC CAMERA | Siemens Gammasonics, Inc. | 1983-12-27 | 104 | 0 |
| K832737 | ECT PROCESSOR | Siemens Gammasonics, Inc. | 1983-09-29 | 49 | 0 |
| K820124 | INTEGRAL SECTOR MODULE | Siemens Gammasonics, Inc. | 1982-03-05 | 46 | 0 |
| K811842 | IMAGER 2000 REAL TIME SYSTEM | Siemens Gammasonics, Inc. | 1981-11-20 | 142 | 0 |
| K811843 | BIOPSY TRANSDUCER | Siemens Gammasonics, Inc. | 1981-08-25 | 55 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda