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510(k) K212230

TruSPECT Radiological Image Processing Station by Spectrum Dynamics Medical, Ltd. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2021
Date Received
July 16, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Spectrum Dynamics Medical, Ltd.

  • K254001 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 4 (January 13, 2026)
  • K253532 — TruSPECT Processing Station (December 30, 2025)
  • K230600 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 4 (April 28, 2023)
  • K190457 — VERITON CT whole body SPECT/CT system (July 12, 2019)
  • K182484 — VERITON CT whole body SPECT/CT system (November 9, 2018)
  • K180514 — VERITON NM (April 25, 2018)
  • K161740 — D-SPECT Scanner, D-SPECT L Scanner (November 4, 2016)

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)