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510(k) K961193

FULL FRAME ZOOM SYSTEM by Xre Corp. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1996
Date Received
March 21, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Other clearances by Xre Corp.

  • K973744 — UNICATH SP BI-PLANE (MODEL M269 & M289) (December 29, 1997)
  • K960998 — XRE COLLIMATOR (April 3, 1996)
  • K945449 — UNICATH LLU ANGIOGRAPHIC SYSTEM (February 27, 1995)
  • K936002 — CINEMAC QAS (September 9, 1994)
  • K933460 — DVFX, MODEL M256 (April 7, 1994)
  • K924828 — BI-N (December 17, 1992)
  • K923654 — POLY DIAGNOST CDX (November 20, 1992)
  • K913685 — UNICATH EP. (November 7, 1991)
  • K912416 — ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM (August 28, 1991)
  • K892849 — UNICATH A (August 9, 1989)

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