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510(k) K020495

INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL by Surgi-Vision, Inc. — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2002
Date Received
February 14, 2002
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 Surgi-Vision, Inc.

  • K111073 — SURGIVISION INC. CLEARPOINT SYSTEM (June 22, 2011)
  • K020790 — INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCE (May 21, 2002)
  • K011781 — INTERCEPT-URETHRAL MICROCOIL (August 31, 2001)
  • K003436 — SURGI-VISION GUIDEWIRE COIL (February 2, 2001)
  • K002916 — SURGI-VISION PROSTATE COIL (November 28, 2000)
  • K002345 — SURGI-VISION URETHRAL COIL (October 11, 2000)
  • K994436 — SURGI-VISION ESOPHAGEAL STYLET COIL (March 14, 2000)
  • K992193 — ENDO-ESOPHAGEAL MR COIL (September 3, 1999)

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)
  • 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)
  • 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)