Upgrade Kit MR GUI PRO, MrJ 3300 Plus

Q: What is the product code of K192690?

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

FDA 510(k) K192690 · Asg Superconductors S.P.A.

Substantially Equivalent

510(k) numberK192690

Submission

Device name: Upgrade Kit MR GUI PRO, MrJ 3300 Plus
Applicant: Asg Superconductors S.P.A.
Genova, IT
Received: September 26, 2019
Decision date: October 24, 2019
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 Upgrade Kit MR GUI PRO, MrJ 3300 Plus cleared by the FDA?

Upgrade Kit MR GUI PRO, MrJ 3300 Plus (K192690) received a 510(k) decision of Substantially Equivalent on October 24, 2019, 28 days after the submission was received.

What is the product code of K192690?

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