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EDDA TECHNOLOGY IQQA-Liver

by EDDA Technology, Inc.

EDDA TECHNOLOGY IQQA-Liver is a Class II device made by EDDA Technology, Inc., cleared under FDA 510(k) K061696 on 13 Nov 2006 and listed in FDA GUDID since 12 Jun 2023 (UDI-DI 00868466000244), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K061696

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00868466000244 UDI-DI Date12 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK061696 Date13 Nov 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061696 decided 13 Nov 2006 Active
  • FDA GUDID UDI-DI 00868466000244 listed 12 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K061696
  2. Listed FDA GUDID 00868466000244

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Edda Technology
Generic name
Radiology DICOM image processing application software
Model / reference
IQQA-Liver
Primary DI / UDI-DI
00868466000244
510(k) Number
FDA product code
LLZ
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)