Atlas FDA

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

Jamieson Film Co. · Predicate Candidate Screening

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

66 daysmedian FDA review time
84 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K970738KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNITJamieson Film Co.1997-05-07680
K971128CAP-35B III/CINE 275Jamieson Film Co.1997-04-28320
K963334JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE Jamieson Film Co.1996-09-11160
K960043KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEMJamieson Film Co.1996-03-27840
K953563VANGUARD XR-350 CINEANGIOGRAM PROJECTORJamieson Film Co.1995-10-05660
K913241JAMIESON JT-CRP CINE FILM PROCESSORJamieson Film Co.1991-09-24640

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