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510(k) K253182

InkSpace Imaging Small Body Array (SBA12PH30x) by Inkspace Imaging, Inc. — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2025
Date Received
September 26, 2025
Clearance Type
Special
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 Inkspace Imaging, Inc.

  • K243675 — InkSpace Imaging Small Body Array (December 20, 2024)
  • K233444 — InkSpace Imaging Small Body Array (January 8, 2024)
  • K223487 — InkSpace Imaging Body Array (December 8, 2022)
  • K213397 — InkSpace Imaging Pediatric Body Array (December 17, 2021)

Other clearances for product code MOS

  • 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)
  • 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)
  • K243316 — XENOVIEW 3.0T Chest Coil (November 19, 2024)
  • K242879 — dS Knee Coil 8ch 1.5T (October 18, 2024)
  • K243033 — dS Wrist coil 8ch 1.5T (October 18, 2024)
  • K242096 — dS FootAnkle Coil 8ch 1.5T (August 12, 2024)