Sopha Medical Systems, Inc.: FDA clearances and approvals
Sopha Medical Systems, Inc. has 8 FDA 510(k) clearances (first 1987, latest 1996), across 3 product codes in 1 review panel. Median 510(k) review time: 106 days.
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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 4 | 4 |
| IYX | Camera, Scintillation (Gamma) | 3 | 3 |
| IXY | Holder, Radiographic Cassette, Wall-Mounted | 1 | 1 |
Review panels
- Radiology (8)
Most recent Sopha Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952190 | TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE | KPS | 1996-01-18 | 254 |
| K942837 | DST-XL | KPS | 1995-01-05 | 204 |
| K921008 | VECTOR SERIES | KPS | 1992-04-27 | 55 |
| K913641 | SOPHY NXT | KPS | 1991-12-17 | 126 |
| K911346 | SOPHYCAMERA DSX BODYTRAK | IYX | 1991-04-18 | 22 |
| K894931 | SOPHYCAMERA DSX RECTANGULAR | IYX | 1989-10-27 | 86 |
| K872132 | SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS | IXY | 1987-10-26 | 145 |
| K872297 | DS-7 NUCLEAR MEDICINE GAMMA CAMERA | IYX | 1987-08-12 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Sopha Medical Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Sopha Medical Systems, Inc. have?
Sopha Medical Systems, Inc. has 8 FDA 510(k) clearances (first 1987, latest 1996), across 3 product codes in 1 review panel.
How long does FDA take to clear Sopha Medical Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sopha Medical Systems, Inc.'s cleared 510(k)s is 106 days.
What devices does Sopha Medical Systems, Inc. make?
Its most frequent FDA product codes are KPS (System, Tomography, Computed, Emission, 4); IYX (Camera, Scintillation (Gamma), 3); IXY (Holder, Radiographic Cassette, Wall-Mounted, 1).
Has Sopha Medical Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sopha Medical Systems, Inc. Related entities may recall under other names.
Next steps
- See all 8 Sopha Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPS, Sopha Medical Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.