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510(k) K920962

MULTIPLE ACCESSORY TO GAMMA CAMERAS by Nu Age Products — Product Code IYZ

K920962 is an FDA 510(k) premarket notification submitted by Nu Age Products for the device "MULTIPLE ACCESSORY TO GAMMA CAMERAS". The FDA issued a decision of Substantially Equivalent on April 17, 1992. The device falls under product code IYZ (Bed, Scanning, Nuclear), a Class I device regulated under 21 CFR 892.1350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1992
Date Received
February 3, 1992
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 for product code IYZ

  • 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)
  • K912181 — E-Z LIFT CRANK IMAGING TABLE (July 17, 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