Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Virtual Imaging · Predicate Candidate Screening

4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K063262AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SVirtual Imaging2006-12-26570
K922313P-LINKVirtual Imaging1992-07-10700
K891695VIEW 1000Virtual Imaging1989-10-272190
K864854VIEW(TM) IMAGE PROCESSING AND VIEWING STATIONVirtual Imaging1987-02-26770

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