Atlas FDA

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

Emi Medical, Inc. · Predicate Candidate Screening

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

14 daysmedian FDA review time
37 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K791429EMISONIC 4290Emi Medical, Inc.1979-09-21570
K781936SCANNER-EMI 7020 AND 7020REmi Medical, Inc.1978-12-04140
K781519EMI SIMULATOR REMOTE CONTROL CONSOLEEmi Medical, Inc.1978-09-14130
K781051EMISONIC 4201Emi Medical, Inc.1978-07-17250
K780995COMPUTERIZED AXIAL TOMOGRAPHYEmi Medical, Inc.1978-06-2280
K7809305543 INDEPENDENT VIEWING SYSTEMEmi Medical, Inc.1978-06-1480
K780928CT5137 HIGH RESOLUTION OPTIONEmi Medical, Inc.1978-06-1490
K780737CT BLANKETS (BOLUS MATERIAL)Emi Medical, Inc.1978-06-02320
K780736CT 5221 DOSE REDUCING COLLIMATORSEmi Medical, Inc.1978-06-02320
K771978CTR 100LEmi Medical, Inc.1977-11-23370
K772125TOMOGRAPHIC SCANNER, COMPUTERIZEDEmi Medical, Inc.1977-11-21100
K771930EMISONIC 4500 TMEmi Medical, Inc.1977-10-27130
K771811EMI CTR 100Emi Medical, Inc.1977-10-19220

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