FDA.report

510(k) K254207

Device
AiORTA - Plan v2.0
Applicant
ViTAA Medical Solutions, Inc.
510(k) number
K254207
Product code
QIH
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-30
Date received
2025-12-29
Regulation
892.2050
Classification name
Automated Radiological Image Processing Software
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Mitchel Benovoy
Address
2590 Rue De Rouen Montreal CA H2K1M6 H2K1M6

FDA Registration Numbers

Source Documents

510(k) summary PDF

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