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510(k) K211964

SubtlePET by Subtle Medical, Inc. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2021
Date Received
June 24, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

Other clearances by Subtle Medical, Inc.

  • K243250 — SubtleHD (1.x) (February 12, 2025)
  • K240290 — AiMIFY (1.x) (August 21, 2024)
  • K241329 — SubtleSYNTH (1.x) (July 11, 2024)
  • K233699 — SubtleREFORMAT (1.x) (April 29, 2024)
  • K223623 — SubtleMR (2.3.x) (May 11, 2023)
  • K203182 — SubtleMR (February 26, 2021)
  • K191688 — SubtleMR (September 16, 2019)
  • K182336 — SubtlePET (November 30, 2018)

Other clearances for product code KPS

  • K260524 — uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panviv (April 3, 2026)
  • K253564 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo (February 13, 2026)
  • K254001 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 4 (January 13, 2026)
  • K253844 — AnyScan 3.0 NM Scanner Family (December 30, 2025)
  • K251370 — Cartesion Prime (PCD-1000A/3) V10.21 (December 1, 2025)
  • K251401 — PennPET Explorer Positron Emission Tomograph (November 25, 2025)
  • K252477 — Hybrid Viewer (00859873006240) (September 9, 2025)
  • K250170 — PHAROS (August 15, 2025)
  • K251561 — Biograph Trinion (July 31, 2025)
  • K251839 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (July 17, 2025)