SIGNA Architect

FDA 510(k) K202966 · Ge Healthcare (Ge Medical Systems, LLC)

Substantially Equivalent

510(k) numberK202966

Submission

Device name
SIGNA Architect
Applicant
Ge Healthcare (Ge Medical Systems, LLC)
Waukesha, WI, US
Received
September 30, 2020
Decision date
November 13, 2020
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 SIGNA Architect cleared by the FDA?

SIGNA Architect (K202966) received a 510(k) decision of Substantially Equivalent on November 13, 2020, 44 days after the submission was received.

What is the product code of K202966?

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