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510(k) K222577

TECHFIT Diagnostic Models by Techfit Digital Surgery, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2023
Date Received
August 25, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Techfit Digital Surgery, Inc.

  • K250297 — TECHFIT Patient-Specific Cranial System (October 27, 2025)
  • K242263 — TECHFIT DISRP® System (December 11, 2024)
  • K230276 — TECHFIT DISRP® System (June 23, 2023)
  • K220199 — AFFINITY Proximal Tibia System (March 21, 2022)

Other clearances for product code LLZ

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  • K253111 — Aeka Imaging (March 13, 2026)
  • K251964 — Mimics Thoracic Planner (March 12, 2026)
  • K253551 — VELYS™ Hip Navigation (March 6, 2026)
  • K253486 — SKIA-Head (Model: SKIA-ST00) (February 23, 2026)
  • K260205 — AS Software Version Asera (February 19, 2026)
  • K253927 — LiveMedica Enterprise PACS (February 6, 2026)
  • K251577 — LAIA XR (February 6, 2026)
  • K253639 — View (January 8, 2026)
  • K253784 — 3DICOM MD Cloud (January 8, 2026)