Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Health Images, Inc. · Predicate Candidate Screening

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

164 daysmedian FDA review time
339 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K964778HI-STAR MRI IMAGING SYSTEMHealth Images, Inc.1997-02-24890
K944724HEALTH IMAGE INC. HI STARHealth Images, Inc.1995-08-303390
K944228HEALTH IMAGES, INC. HI-STANDARDHealth Images, Inc.1995-07-203230
K911746H.I.STANDARD CALIBRE UPGRADEHealth Images, Inc.1991-08-161200
K890092HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICEHealth Images, Inc.1989-06-231640

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