Siemens Gammasonics, Inc.: FDA filings under this applicant name
FDA lists 53 510(k) clearances under the applicant name “Siemens Gammasonics, Inc.” (first 1981, latest 1994), across 14 product codes in 1 review panel. Median 510(k) review time under this name: 64 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Siemens Healthineers, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | 11 | 11 |
| KPS | System, Tomography, Computed, Emission | 9 | 9 |
| LLZ | System, Image Processing, Radiological | 7 | 7 |
| IZI | System, X-Ray, Angiographic | 5 | 5 |
| JWM | System, Tomographic, Nuclear | 4 | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| IYZ | Bed, Scanning, Nuclear | 3 | 3 |
| LMC | Camera, Multi Format, Radiological | 3 | 3 |
| LMD | System, Digital Image Communications, Radiological | 3 | 3 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
Plus 4 more product codes.
Review panels
- Radiology (53)
Most recent Siemens Gammasonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934766 | CARBON FIBER PALLET | IYX | 1994-02-18 | 137 |
| K933664 | POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) | IZI | 1993-12-15 | 140 |
| K933256 | FAN BEAM COLLIMATOR | IYX | 1993-10-29 | 115 |
| K920319 | SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI | LLZ | 1992-10-20 | 270 |
| K923582 | SIENET CAMERA SERVER | LMD | 1992-10-14 | 86 |
| K922373 | MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM | KPS | 1992-08-17 | 89 |
| K922372 | MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM | KPS | 1992-08-17 | 89 |
| K920310 | SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE | LMD | 1992-03-30 | 67 |
| K920309 | SIENET DIAGNOSTIC REPORTING CONSOLE | LLZ | 1992-03-20 | 57 |
| K914313 | HICOR | IZI | 1991-11-27 | 65 |
43 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Siemens Gammasonics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Siemens Medical Solutions USA, Inc. (784 510(k)s)
- Siemens Healthcare Diagnostics, Inc. (245 510(k)s)
- Siemens Corp. (67 510(k)s)
- Siemens Elema AB (63 510(k)s)
- Siemens Hearing Instruments, Inc. (42 510(k)s)
- Siemens Medi Cal Solutions, Inc. (32 510(k)s)
- Siemens AG Medical Solutions (31 510(k)s)
- Siemens Healthcare GmbH (31 510(k)s)
- Siemens Medical Systems, Inc. (25 510(k)s)
- Siemens Healthcare Diagnostics Products GmbH (18 510(k)s)
- Siemens AG (15 510(k)s)
- Siemens Medical Electronics (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Siemens Gammasonics, Inc.?
FDA lists 53 510(k) clearances under the applicant name “Siemens Gammasonics, Inc.” (first 1981, latest 1994), across 14 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Siemens Gammasonics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Gammasonics, Inc. is 64 days.
Which FDA product codes appear under Siemens Gammasonics, Inc.?
The most frequent FDA product codes under this applicant name are IYX (Camera, Scintillation (Gamma), 11); KPS (System, Tomography, Computed, Emission, 9); LLZ (System, Image Processing, Radiological, 7).
Next steps
- See all 53 Siemens Gammasonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYX, Siemens Gammasonics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.