Home / 510(k) Clearances / K223484

510(k) K223484

IGAR System (1001.A) by Insight Medbotics, Inc. — Product Code MOS

K223484 is an FDA 510(k) premarket notification submitted by Insight Medbotics, Inc. for the device "IGAR System (1001.A)". The FDA issued a decision of Substantially Equivalent on July 20, 2023. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2023
Date Received
November 18, 2022
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 for product code MOS

  • K260947 — 0.55T 12Ch Breast Coil (April 23, 2026)
  • 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)

FDA data resources