Home / 510(k) Clearances / K945449

510(k) K945449

UNICATH LLU ANGIOGRAPHIC SYSTEM by Xre Corp. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1995
Date Received
November 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

Other clearances by Xre Corp.

  • K973744 — UNICATH SP BI-PLANE (MODEL M269 & M289) (December 29, 1997)
  • K961193 — FULL FRAME ZOOM SYSTEM (June 17, 1996)
  • K960998 — XRE COLLIMATOR (April 3, 1996)
  • 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)

Other clearances for product code IZI

  • K243645 — IC-Flow™ Imaging System 2.0 (September 22, 2025)
  • K243077 — Affirm 800 (June 27, 2025)
  • K231986 — Modus IR (March 25, 2024)
  • K234090 — EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) (March 20, 2024)
  • K231075 — Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (June 20, 2023)
  • K230727 — SPY Portable Handheld Imaging (SPY-PHI) System (June 5, 2023)
  • K222240 — EXPLORER AIR® II (February 28, 2023)
  • K214097 — Explorer Air II (February 25, 2022)
  • K202391 — DIR 800 (January 21, 2021)
  • K192761 — Asimov-MKS Imaging System (January 17, 2020)