510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042408Substantially Equivalent

Iqqa-Chest Software Package

Edda Technology, Inc., Deer Field IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042408 is the FDA 510(k) clearance record for IQQA-CHEST SOFTWARE PACKAGE, a class II device, cleared for Edda Technology, Inc. on under FDA product code OMJ (Chest X-Ray Computer Aided Detection). FDA's definition for product code OMJ reads: "To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review". FDA records list 5 510(k) clearances for Edda Technology, Inc., from to . As of , FDA records show no recalls naming K042408.

Clearance record

Decision date
Received
(35 days to decision)
Product code
OMJ Chest X-Ray Computer Aided Detection
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Edda Technology, Inc. P.O. Box 7007, Deer Field IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMJ

Trailing 12 months

FDA records hold no clearances under product code OMJ in the trailing twelve months.

FDA records show no clearances under product code OMJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OMJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260