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Iqqa-Chest Software Package

by EDDA Technology, Inc.

510(k) K042408

Iqqa-Chest Software Package is a Class II device made by EDDA Technology, Inc., cleared under FDA 510(k) K042408 on 8 Oct 2004, active as of 9 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 9 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 9 Oct 2026.

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042408 Date8 Oct 2004ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OMJ
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K042408

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K042408
UDI-DISize and differences
EDDA TECHNOLOGY IQQA-Chest
EDDA Technology, Inc.
IQQA-Chest00868466000206 —On the market

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