Sireskop SX

FDA 510(k) K951358 · Siemens Medical Solutions USA, Inc.

Substantially Equivalent

510(k) numberK951358

Submission

Device name
Sireskop SX
Applicant
Siemens Medical Solutions USA, Inc.
Iselin, NJ, US
Received
March 24, 1995
Decision date
May 15, 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 Sireskop SX cleared by the FDA?

Sireskop SX (K951358) received a 510(k) decision of Substantially Equivalent on May 15, 1995, 52 days after the submission was received.

What is the product code of K951358?

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