510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OMJClass II

Chest X-Ray Computer Aided Detection

21 CFR 892.2050 / Radiology
FDA source (opens on fda.gov)

OMJ is the FDA product code for Chest X-Ray Computer Aided Detection, a class II device type, regulated under 21 CFR 892.2050. FDA's definition for this code reads: "To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OMJ
Device name
Chest X-Ray Computer Aided Detection
FDA definition
To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review.
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OMJ

By decision year
1 clearance under product code OMJ with a decision year between 2004 and 2004, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OMJ by decision year
YearClearances
20041

Applicants with the most clearances

Product code OMJ
Applicants holding the most 510(k) clearances under product code OMJ
ApplicantClearances
Edda Technology, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code