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510(k) K912181

E-Z LIFT CRANK IMAGING TABLE by Med-Tron Products, Inc. — Product Code IYZ

K912181 is an FDA 510(k) premarket notification submitted by Med-Tron Products, Inc. for the device "E-Z LIFT CRANK IMAGING TABLE". The FDA issued a decision of Substantially Equivalent on July 17, 1991. 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
July 17, 1991
Date Received
May 16, 1991
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)
  • K912135 — XY IMAGING TABLE (July 17, 1991)
  • K911561 — XYZ IMAGING TABLE WITH FOOT PUMP (July 15, 1991)
  • K911564 — E-Z LIFT IMAGING TABLE WITH FOOT PUMP (July 15, 1991)
  • K905827 — FULL VIEW OMEGA TABLE (January 28, 1991)
  • K903988 — PANORAMIC OMEGA IMAGING TABLE (October 23, 1990)
  • K903901 — SCANNING COT (September 21, 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)
  • K912481 — ECT CARBON FIBER PALLET, MODIFICATION (August 2, 1991)
  • K912286 — CARDIAC SPECT PALLET (August 2, 1991)
  • K912135 — XY IMAGING TABLE (July 17, 1991)
  • K911561 — XYZ IMAGING TABLE WITH FOOT PUMP (July 15, 1991)
  • K911564 — E-Z LIFT IMAGING TABLE WITH FOOT PUMP (July 15, 1991)
  • K903901 — SCANNING COT (September 21, 1990)
  • K903767 — ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL (September 7, 1990)

FDA data resources