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510(k) K232021

Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T by Philips Healthcare (Suzhou) Co., Ltd. — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2023
Date Received
July 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coil, Magnetic Resonance, Specialty
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Philips Healthcare (Suzhou) Co., Ltd.

  • K252992 — CT Rembra RT; CT Areta RT; CT Rembra (March 23, 2026)
  • K260519 — Smart Fit TorsoCardiac 1.5T (March 20, 2026)
  • K242329 — CT Collaboration Live (November 18, 2024)
  • K232491 — CT 5300 (May 3, 2024)
  • K233600 — Smart Fit Knee 3.0T (February 5, 2024)
  • K223311 — Philips CT 3500 (December 22, 2022)
  • K212441 — Philips Incisive CT (April 27, 2022)
  • K212864 — dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T (December 1, 2021)
  • K211168 — Philips Incisive CT on Trailer (November 22, 2021)
  • K203514 — Precise Position (June 17, 2021)

Other clearances for product code MOS

  • K252587 — HD 8Ch Wrist Array (April 14, 2026)
  • K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Rece (April 1, 2026)
  • K260519 — Smart Fit TorsoCardiac 1.5T (March 20, 2026)
  • K252179 — GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Rece (February 10, 2026)
  • K253738 — 3.0T AIR 32CH HNA (January 23, 2026)
  • K254190 — dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS Hea (January 14, 2026)
  • K253182 — InkSpace Imaging Small Body Array (SBA12PH30x) (October 20, 2025)
  • K243428 — e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Co (July 17, 2025)
  • K244054 — 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247 (February 28, 2025)
  • K243675 — InkSpace Imaging Small Body Array (December 20, 2024)