Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sony Medical Systems · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
103 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K024188 | UP-DF500 FILMSTATION DIGITAL FILM IMAGER | Sony Medical Systems | 2003-02-04 | 47 | 0 |
| K970999 | SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR | Sony Medical Systems | 1997-05-20 | 62 | 0 |
| K961680 | SONY DKR-700 DIGITAL STILL RECORDER | Sony Medical Systems | 1996-07-03 | 63 | 0 |
| K931170 | SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS) | Sony Medical Systems | 1993-06-14 | 98 | 0 |
| K924708 | CINENET CARDIAC IMAGE NETWORK | Sony Medical Systems | 1992-12-30 | 103 | 0 |
| K921275 | SONY LASER VIDEODISC RECORDING SYSTEM | Sony Medical Systems | 1992-06-10 | 82 | 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