510(k) clearances

AiORTA - Plan v2.0

ViTAA Medical Solutions, Inc. · Radiology

K254207Substantially EquivalentTraditionalQIH
Open FDA's page for this record
Third party flag
N
City
Montreal
Advisory committee description
Radiology
Address 1
2590 Rue De Rouen
Statement or summary
Summary
Product code
QIH
Zip code
H2K1M6
Applicant
ViTAA Medical Solutions, Inc.
Decision date
2026-03-30
Decision code
SESE
Country code
CA
Device name
AiORTA - Plan v2.0
Advisory committee
RA
Contact
Mitchel Benovoy
K number
K254207
Date received
2025-12-29
Review advisory committee
RA
Postal code
H2K1M6
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Automated Radiological Image Processing Software
Medical specialty description
Radiology
Regulation number
892.2050
Device class
2
Registration number
3036725840, 3003775006, 2936485, 3023217364, 8043933, 3027977501, 3019844085, 3017297314, 3010398867, 9710602, 3021637148, 3017840913, 3001722928, 3021970996, 3042175844, 1826555, 3017936978, 3017489096, 3003768277, 3012747207, 3015763655, 3045078825, 3021907554, 3009731198, 3014310698, 3044776706, 3007194257, 3013552417, 1000432246, 3033527241, 3027986210, 3003594449, 3010102386, 3030655434, 3030598283, 3024812789, 3017102960, 3024820186, 3008496839, 3016759115 +200 more
FEI number
3003405980, 3036725840, 3003775006, 2936485, 3023217364, 3027977501, 3019844085, 3003304172, 3017297314, 3010398867, 3003309342, 3021637148, 3017840913, 3001722928, 3021970996, 3042175844, 1826555, 3017936978, 3017489096, 3012747207, 3015763655, 3045078825, 3021907554, 3009731198, 3014310698, 3044776706, 3003208270, 3007194257, 3013552417, 1000432246, 3003310366, 3033527241, 3027986210, 3003594449, 3010102386, 3030655434, 3030598283, 3024812789, 3017102960, 3024820186 +200 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.