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iQ View V5

by First Source Inc.

iQ View V5 (200-CA-308) is a medical device (FDA Class II) made by First Source Inc., cleared under FDA 510(k) K203703 on 24 Mar 2021 and listed in FDA GUDID since 13 Jun 2023 (UDI-DI G221200CA3080), active as of 23 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 23 Oct 2026

Documents

510(k) K203703

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberG221200CA3080 UDI-DI Date13 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK203703 Date24 Mar 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203703 decided 24 Mar 2021 Active
  • FDA GUDID UDI-DI G221200CA3080 listed 13 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203703
  2. Listed FDA GUDID G221200CA3080

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
iQ View
Generic name
Radiology DICOM image processing application software
Model / Ref / Catalog
V5, 200-CA-308
Primary DI / UDI-DI
G221200CA3080
510(k) Number
FDA product code
MQB, IZL, LLZ
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.1680, 892.1720, 892.2050
GUDID distribution status
In Commercial Distribution

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Properties

Other properties (15, all answered No)