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Imbio RV/LV 2.1

by Imbio, LLC

Imbio RV/LV 2.1 is a Class II device made by Imbio, LLC, cleared under FDA 510(k) K203256 on 9 Mar 2021 and listed in FDA GUDID since 10 Aug 2021 (UDI-DI 00850894007636), 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) K203256

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 Number00850894007636 UDI-DI Date10 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK203256 Date9 Mar 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203256 decided 9 Mar 2021 Active
  • FDA GUDID UDI-DI 00850894007636 listed 10 Aug 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203256
  2. Listed FDA GUDID 00850894007636

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Imbio RV/LV
Generic name
X-ray image interpretive software
Model / reference
2.1
Primary DI / UDI-DI
00850894007636
510(k) Number
FDA product code
QIH
GMDN term
X-ray image interpretive software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: X-ray image interpretive software

Cleared under the same submission (K203256)

Similar devices

Other devices filed under FDA product code QIH (Automated Radiological Image Processing Software).

Other devices from Imbio, LLC

  • Imbio Freya 5.0.0

    Class II

  • Imbio LDA 2.4.1

    Class II

  • Imbio LDA 5.0.2

    Class II

  • Imbio LDA 2.5.2

    Class II

See all devices from Imbio, LLC →

Properties

  • Prescription use
  • Manufacturing date
Other properties (13, all answered No)