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iQ Flex Edge

by First Source Inc.

iQ Flex Edge (500MC901) is a radiological imaging system transport kit (FDA Class I; FDA product code IYB, Tube Mount, X-Ray, Diagnostic) made by First Source Inc., listed in FDA GUDID since 25 Aug 2026 (UDI-DI G221500MC901), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberG221500MC901 UDI-DI Date25 Aug 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
iQ Flex
Generic name
Radiological imaging system transport kit
Model / Ref / Catalog
Edge, 500MC901
Primary DI / UDI-DI
G221500MC901
FDA product code
IYB
GMDN term
Radiological imaging system transport kit
Device class
Class I
Regulation number
892.1770
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code IYB (Tube Mount, X-Ray, Diagnostic).

Other devices from First Source Inc.

  • iQ Flex Pro

    Class II
  • iQ View V5

    Class II
  • iQ Flex MD Open recall

    Class II
  • iQ Elevation 1

    Class I

See all devices from First Source Inc. →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)