Philips CD Medical Recorder, View Station, Dup[[Lication Station

FDA 510(k) K945460 · Philips Medical Systems North America, Inc.

Substantially Equivalent

510(k) numberK945460

Submission

Device name
Philips CD Medical Recorder, View Station, Dup[[Lication Station
Applicant
Philips Medical Systems North America, Inc.
Shelton, CT, US
Received
November 7, 1994
Decision date
March 14, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAA – System, X-Ray, Fluoroscopic, Image-Intensified
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

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Questions and answers

When was Philips CD Medical Recorder, View Station, Dup[[Lication Station cleared by the FDA?

Philips CD Medical Recorder, View Station, Dup[[Lication Station (K945460) received a 510(k) decision of Substantially Equivalent on March 14, 1995, 127 days after the submission was received.

What is the product code of K945460?

The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.