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510(k) K903901

SCANNING COT by Med-Tron Products, Inc. — Product Code IYZ

K903901 is an FDA 510(k) premarket notification submitted by Med-Tron Products, Inc. for the device "SCANNING COT". The FDA issued a decision of Substantially Equivalent on September 21, 1990. The device falls under product code IYZ (Bed, Scanning, Nuclear), a Class I device regulated under 21 CFR 892.1350. Med-Tron Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1990
Date Received
August 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Scanning, Nuclear
Device Class
Class I
Regulation Number
892.1350
Review Panel
RA
Submission Type

Other clearances by Med-Tron Products, Inc.

  • K952701 — MED-TRON SPECT IMAGING TABLE (July 6, 1995)
  • K911691 — XYZ CRANK IMAGING TABLE (August 9, 1991)
  • K912181 — E-Z LIFT CRANK IMAGING TABLE (July 17, 1991)
  • K912135 — XY IMAGING TABLE (July 17, 1991)
  • K911564 — E-Z LIFT IMAGING TABLE WITH FOOT PUMP (July 15, 1991)
  • K911561 — XYZ IMAGING TABLE WITH FOOT PUMP (July 15, 1991)
  • K905827 — FULL VIEW OMEGA TABLE (January 28, 1991)
  • K903988 — PANORAMIC OMEGA IMAGING TABLE (October 23, 1990)

Other clearances for product code IYZ

  • K920962 — MULTIPLE ACCESSORY TO GAMMA CAMERAS (April 17, 1992)
  • K915541 — SPECT TABLE, MODEL #056-760 (January 17, 1992)
  • K911691 — XYZ CRANK IMAGING TABLE (August 9, 1991)
  • K912286 — CARDIAC SPECT PALLET (August 2, 1991)
  • K912481 — ECT CARBON FIBER PALLET, MODIFICATION (August 2, 1991)
  • K912181 — E-Z LIFT CRANK IMAGING TABLE (July 17, 1991)
  • K912135 — XY IMAGING TABLE (July 17, 1991)
  • K911564 — E-Z LIFT IMAGING TABLE WITH FOOT PUMP (July 15, 1991)
  • K911561 — XYZ IMAGING TABLE WITH FOOT PUMP (July 15, 1991)
  • K903767 — ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL (September 7, 1990)

FDA data resources