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• • Terminated Z-1477-04 FDA Unclassified (pre-2012) ·initiated 16 Jun 2004 ·on shared 510(k) K945293

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Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 5 Jan 1995 Cleared FDA 510(k) K945293
2. 16 Jun 2004 Recall initiated FDA recalls Z-1477-04

510(k) Number

K945293 ↗

FDA product code

IZI

Device class

Class II

Regulation

21 CFR Part 892.1600

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Other devices filed under FDA product code IZI (System, X-Ray, Angiographic).

• INTEGRATED INNOVA - S5I SYSTEM OPTION by GE Healthcare
• BRANSIST SAFIRE by SHIMADZU CORPORATION
• SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400 by Shimadzu Medical Systems
• OPTIMA ARCHIVAL AND RETRIEVAL SYSTEM by Diagnostic Archives, Inc.
• ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION by GE MEDICAL SYSTEMS, INC.
• SPY FLUORESCENT IMAGING SYSTEM by Novadaq Technologies Inc
• DICOMNET by Lockheed Martin Communications Systems
• ATLAS 2000 VASCULAR ROAD MAPPING SYSTEM by Squires & Assoc., Inc.
• ALLURA XPER FD10 by Philips Medical Systems North America, Inc.
• SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 by Novadaq Technologies Inc

• Symbia Intevo Bold combination

  Class IIb

  CE/MDR

• Biograph Vision 600 Combination

  Class IIb

  CE/MDR

• CS-20-1 Uniform Phantom Combi

  Class IIb

  CE/MDR

• Biograph Vision Quadra Combination

  Class IIb

  CE/MDR

See all devices from Siemens Medical Solutions USA, Inc. →