Atlas FDA

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

Sterling Diagnostic Imaging, Inc. — Predicate Candidate Screening

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

75 daysmedian FDA review time
117 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K980970IIRAD DIRECTRAY OPERATOR CONSOLESterling Diagnostic Imaging, Inc.1998-06-08840
K980220IISYS PACS SYSTEMSterling Diagnostic Imaging, Inc.1998-02-13220
K974423ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FASterling Diagnostic Imaging, Inc.1997-12-22280
K973206STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHYSterling Diagnostic Imaging, Inc.1997-12-041000
K972660RAVEN DRY PRINTERSterling Diagnostic Imaging, Inc.1997-11-101170
K973028HELIOS LASER IMAGER 1417Sterling Diagnostic Imaging, Inc.1997-10-28750
K964250LINX NETWORKING SYSTEMSterling Diagnostic Imaging, Inc.1996-12-18550

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