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AiORTA - Plan

by Vitaa Medical Solutions Inc.

AiORTA - Plan is a Class II device made by Vitaa Medical Solutions Inc., cleared under FDA 510(k) K250337 on 30 Oct 2025 and listed in FDA GUDID since 30 Mar 2026 (UDI-DI G703AIORTAPLAN0), 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) K250337

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 NumberG703AIORTAPLAN0 UDI-DI Date30 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK250337 Date30 Oct 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K250337 decided 30 Oct 2025 Active
  • FDA GUDID UDI-DI G703AIORTAPLAN0 listed 30 Mar 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K250337
  2. Listed FDA GUDID G703AIORTAPLAN0

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Radiological PACS-dedicated management software
Model / reference
AiORTA - Plan
Primary DI / UDI-DI
G703AIORTAPLAN0
510(k) Number
FDA product code
QIH
GMDN term
Radiological PACS-dedicated management software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Similar devices

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

Other devices from Vitaa Medical Solutions Inc.

Properties

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