Devices · Philips Medical Systems Nederlands B.V.

MR 5300 and MR 7700 R11 MR Systems

510(k)K223442RadiologyLNH

Philips Medical Systems Nederlands B.V. is listed for MR 5300 and MR 7700 R11 MR Systems (K223442). The FDA list gives December 23, 2022 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is LNH. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223442

Official FDA database record

Date of final decision: December 23, 2022
Company on the FDA list: Philips Medical Systems Nederlands B.V.
Lead panel: Radiology
Primary product code: LNH
openFDA device name for the code: System, Nuclear Magnetic Resonance Imaging
Device class: 2
Regulation number: 892.1000
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary