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510(k) K241984

Hi-D Imaging 4TAVR by Hi-D Imaging AG — Product Code QIH

K241984 is an FDA 510(k) premarket notification submitted by Hi-D Imaging AG for the device "Hi-D Imaging 4TAVR". The FDA issued a decision of Substantially Equivalent on April 2, 2025. The device falls under product code QIH (Automated Radiological Image Processing Software), a Class II device regulated under 21 CFR 892.2050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2025
Date Received
July 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Radiological Image Processing Software
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.

Other clearances for product code QIH

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  • K253690 — LungMaps (June 15, 2026)
  • K253172 — MediAI-OA (June 15, 2026)
  • K260300 — WatchMate Software (June 15, 2026)
  • K260406 — Brainomix 360 Hyperdensity (June 12, 2026)
  • K260322 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (June 11, 2026)
  • K260497 — DEEPVESSEL Plaque (June 4, 2026)
  • K260077 — OrthoGrid Hip AI® 4.0 (May 29, 2026)
  • K261405 — ANDI 2.2 (May 28, 2026)
  • K260324 — Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning (May 22, 2026)

FDA data resources