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Lvivo Software Application Platform Lvivo_Platform

by Dia Imaging Analysis, Ltd.

Lvivo Software Application Platform Lvivo_Platform is an ultrasound imaging system application software (FDA Class II; FDA product code QIH, Automated Radiological Image Processing Software) made by Dia Imaging Analysis, Ltd., cleared under FDA 510(k) K202546 on 29 Sep 2020 and listed in FDA GUDID since 31 Aug 2022 (UDI-DI 07290019352006), 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) K202546

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 Number07290019352006 UDI-DI Date31 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK202546 Date29 Sep 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K202546 decided 29 Sep 2020 Active
  • FDA GUDID UDI-DI 07290019352006 listed 31 Aug 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K202546
  2. Listed FDA GUDID 07290019352006

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lvivo Software Application Platform
Generic name
Ultrasound imaging system application software
Model / reference
Lvivo_Platform
Primary DI / UDI-DI
07290019352006
510(k) Number
FDA product code
QIH
GMDN term
Ultrasound imaging system application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
Other properties (14, all answered No)