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510(k) K893826

QRSYSTEMS H.D. NUCLEAR IMAGING TABLE by Qrsystems, Inc. — Product Code IYZ

K893826 is an FDA 510(k) premarket notification submitted by Qrsystems, Inc. for the device "QRSYSTEMS H.D. NUCLEAR IMAGING TABLE". The FDA issued a decision of Substantially Equivalent on August 2, 1989. 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
August 2, 1989
Date Received
May 24, 1989
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

  • 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)
  • K912135 — XY IMAGING TABLE (July 17, 1991)
  • K912181 — E-Z LIFT CRANK 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)

FDA data resources