MAGNETOM Avanto Fit

FDA 510(k) K190757 · Siemens Medical Solution USA, Inc.

Substantially Equivalent

510(k) numberK190757

Submission

Device name
MAGNETOM Avanto Fit
Applicant
Siemens Medical Solution USA, Inc.
Malvern, PA, US
Received
March 25, 2019
Decision date
May 31, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 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 Avanto Fit cleared by the FDA?

MAGNETOM Avanto Fit (K190757) received a 510(k) decision of Substantially Equivalent on May 31, 2019, 67 days after the submission was received.

What is the product code of K190757?

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