Atlas FDA

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

Source-Ray, Inc. — Predicate Candidate Screening

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

77 daysmedian FDA review time
394 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K163063UC-5000 Mobile X-RaySource-Ray, Inc.2016-12-12400
K133959PODIATRY X-RAY SYSTEMSource-Ray, Inc.2015-01-223940
K090655PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260Source-Ray, Inc.2009-07-141250
K071392PXS-810, PODIATRY X-RAY SYSTEMSource-Ray, Inc.2007-08-03770
K062472OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSource-Ray, Inc.2006-10-31680
K052001MODEL SR-115 PORTABLE X-RAY SYSTEMSource-Ray, Inc.2005-08-11170
K043062MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEMSource-Ray, Inc.2004-12-13380
K030494SR-130Source-Ray, Inc.2003-05-20900

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