Syncra Tilt Option for Angio Diagnost 5

FDA 510(k) K940696 · Philips Medical Systems North America, Inc.

Substantially Equivalent

510(k) numberK940696

Submission

Device name
Syncra Tilt Option for Angio Diagnost 5
Applicant
Philips Medical Systems North America, Inc.
Shelton, CT, US
Received
February 16, 1994
Decision date
March 16, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KXJ – Table, Radiologic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1980
Specialty
Radiology

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Questions and answers

When was Syncra Tilt Option for Angio Diagnost 5 cleared by the FDA?

Syncra Tilt Option for Angio Diagnost 5 (K940696) received a 510(k) decision of Substantially Equivalent on March 16, 1994, 28 days after the submission was received.

What is the product code of K940696?

The FDA product code is KXJ – Table, Radiologic, a Class II (moderate risk) device regulated under 21 CFR 892.1980.