Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
S & S X-Ray Products, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031574 | SQUEEZE-EASE MAMMOGRAPHY CUSHION | S & S X-Ray Products, Inc. | 2003-08-04 | 76 | 0 |
| K944040 | PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM | S & S X-Ray Products, Inc. | 1995-07-21 | 337 | 0 |
| K883317 | DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST | S & S X-Ray Products, Inc. | 1989-04-26 | 264 | 0 |
| K850614 | SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY | S & S X-Ray Products, Inc. | 1985-03-26 | 39 | 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