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510(k) K213735

dS Sentinelle Breast 16ch 1.5T Coil by Invivo Corporation (Business Trade Name: Philips) — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2022
Date Received
November 29, 2021
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 Invivo Corporation (Business Trade Name: Philips)

  • K232762 — dS Breast Coil 7ch 1.5T (October 3, 2023)
  • K222325 — 8ch Wrist Coil (August 31, 2022)
  • K222257 — 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil (August 23, 2022)
  • K213727 — dS Sentinelle Breast 16ch 3.0T Coil (August 8, 2022)
  • K213351 — ds Head 32ch 3.0T (October 29, 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)