Atlas FDA

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

Litton Medical Systems · Predicate Candidate Screening

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

11 daysmedian FDA review time
13 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K770338X-RAY CONTROL & X-RAY HV GENERATORLitton Medical Systems1977-03-01110
K770333FLUOROSCOPE, C-ARMLitton Medical Systems1977-03-01110
K770336X-RAY TUBE, ROTATING ANODELitton Medical Systems1977-03-01110
K770337FLUOROSCOPIC ASSEMBLY, IMAGE INTENS.Litton Medical Systems1977-03-01110
K770334TILTING X-RAY TABLELitton Medical Systems1977-03-01110
K770335COLLIMATOR, AUTOMATICLitton Medical Systems1977-02-28100
K760568SINGLE PHASE X-RAY CONTROLS & HV GENERATORSLitton Medical Systems1976-09-15130
K760569THREE PHASE X-RAY CONTROLS & HV GENERATORSLitton Medical Systems1976-09-15130

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