Siremobil Compact

FDA 510(k) K963093 · Siemens Medical Solutions USA, Inc.

Substantially Equivalent

510(k) numberK963093

Submission

Device name
Siremobil Compact
Applicant
Siemens Medical Solutions USA, Inc.
Iselin, NJ, US
Received
August 8, 1996
Decision date
September 3, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

Fluoroscopy of the human body.

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Questions and answers

When was Siremobil Compact cleared by the FDA?

Siremobil Compact (K963093) received a 510(k) decision of Substantially Equivalent on September 3, 1996, 26 days after the submission was received.

What is the product code of K963093?

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