Sony Medical Systems: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sony Medical Systems” (first 1992, latest 2003), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 72 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | 2 | 2 |
| LMB | Device, Digital Image Storage, Radiological | 2 | 2 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| LMC | Camera, Multi Format, Radiological | 1 | 1 |
Review panels
- Radiology (6)
Most recent Sony Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K024188 | UP-DF500 FILMSTATION DIGITAL FILM IMAGER | LMC | 2003-02-04 | 47 |
| K970999 | SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR | JAK | 1997-05-20 | 62 |
| K961680 | SONY DKR-700 DIGITAL STILL RECORDER | LMB | 1996-07-03 | 63 |
| K931170 | SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS) | IZI | 1993-06-14 | 98 |
| K924708 | CINENET CARDIAC IMAGE NETWORK | IZI | 1992-12-30 | 103 |
| K921275 | SONY LASER VIDEODISC RECORDING SYSTEM | LMB | 1992-06-10 | 82 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-01-13.
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.
- Sony Electronics, Inc. (8 510(k)s)
- Sony Medical Electronics Co. (8 510(k)s)
- Sony Corp. of America (2 510(k)s)
- Sony Corporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sony Medical Systems?
FDA lists 6 510(k) clearances under the applicant name “Sony Medical Systems” (first 1992, latest 2003), across 4 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 Sony Medical Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sony Medical Systems is 72 days.
Which FDA product codes appear under Sony Medical Systems?
The most frequent FDA product codes under this applicant name are IZI (System, X-Ray, Angiographic, 2); LMB (Device, Digital Image Storage, Radiological, 2); JAK (System, X-Ray, Tomography, Computed, 1).
Next steps
- See all 6 Sony Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code IZI, Sony Medical Systems'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.