Home / 510(k) Clearances / K964141

510(k) K964141

GE STERILE DISPOSABLE EQUIPMENT COIL COVER by Contour Fabricators, Inc. — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1997
Date Received
October 15, 1996
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 Contour Fabricators, Inc.

  • K090773 — CFI ULTRASOUND PROBE DRAPE (September 18, 2009)
  • K970900 — INSTRUMENT HOLDER (May 22, 1997)
  • K971040 — CABLE HOLDER, SUCTION TUBE HOLDER (April 16, 1997)
  • K970185 — STERILE DISPOSABLE EQUIPMENT MAGNET COVER (April 10, 1997)
  • K963453 — CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) (November 15, 1996)
  • K820692 — BANDBAG, WRAP, STERILE (May 3, 1982)
  • K782155 — GENERAL EQUIPMENT COVER (January 17, 1979)

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)