Magnetom Open Viva with Permanent Magnet

FDA 510(k) K994316 · Siemens Medical Corp.

Substantially Equivalent

510(k) numberK994316

Submission

Device name
Magnetom Open Viva with Permanent Magnet
Applicant
Siemens Medical Corp.
Iselin, NJ, US
Received
December 22, 1999
Decision date
January 14, 2000
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LNH – System, Nuclear Magnetic Resonance Imaging
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1000
Specialty
Radiology

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Questions and answers

When was Magnetom Open Viva with Permanent Magnet cleared by the FDA?

Magnetom Open Viva with Permanent Magnet (K994316) received a 510(k) decision of Substantially Equivalent on January 14, 2000, 23 days after the submission was received.

What is the product code of K994316?

The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.