Atlas FDA

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

General X-Ray, Inc. — Predicate Candidate Screening

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

19 daysmedian FDA review time
33 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K800998ATLAS-S X-RAY SYSTEM W/KETROMAT GEN.General X-Ray, Inc.1980-05-28330
K790451X-RAY UNITS, GX-101, UCIS-510 AND GX-111General X-Ray, Inc.1979-03-28230
K790511MOBILE X-RAY UNITGeneral X-Ray, Inc.1979-03-26100
K790393PORTABLE X-RAY UNIT, MATRIX S GX-101General X-Ray, Inc.1979-03-26280
K790512PORTABLE X-RAY UNITGeneral X-Ray, Inc.1979-03-26100
K790443PORTABLE X-RAY UNITGeneral X-Ray, Inc.1979-03-26190
K790392510 CARBINETTE X-RAY UNITGeneral X-Ray, Inc.1979-03-26280
K781976MOBILE X-RAY UNITGeneral X-Ray, Inc.1978-12-0470
K781675X-RAY COLLIMATORGeneral X-Ray, Inc.1978-12-04660
K781975MOBILE CARRIERGeneral X-Ray, Inc.1978-12-0470
K781676X-RAY STAND, PORTABLEGeneral X-Ray, Inc.1978-10-17180
K781590PORTABLE X-RAY UNITGeneral X-Ray, Inc.1978-10-03150
K781030X-RAY UNIT, PORTABLE GX-101 AECGeneral X-Ray, Inc.1978-07-17280
K780963X-RAY SYSTEMGeneral X-Ray, Inc.1978-06-27150

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