Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Suni Medical Imaging, 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) |
|---|---|---|---|---|---|
| K162585 | SuniIQ Digital Radiography System | Suni Medical Imaging, Inc. | 2016-11-04 | 49 | 0 |
| K083917 | X-RAY, TOMOGRAPHY, COMPUTED, DENTAL | Suni Medical Imaging, Inc. | 2009-06-02 | 154 | 0 |
| K070219 | SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM | Suni Medical Imaging, Inc. | 2007-02-07 | 15 | 0 |
| K060149 | SUNIPAN IMAGING SYSTEM & ACCESSORIES | Suni Medical Imaging, Inc. | 2006-02-03 | 14 | 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