MR 5300 and MR 7700 R11 MR Systems
K-Number: K223442 · 2022-12-23
Decision Date2022-12-23
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MR 5300 and MR 7700 R11 MR Systems is a medical device manufactured by Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2022-12-23 under approval number K223442. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MR 5300 and MR 7700 R11 MR Systems?
MR 5300 and MR 7700 R11 MR Systems is a medical device that received FDA 510(k) clearance on 2022-12-23. It is manufactured by Philips Medical Systems Nederlands B.V.. The 510(k) number is K223442.
When was MR 5300 and MR 7700 R11 MR Systems approved by the FDA?
MR 5300 and MR 7700 R11 MR Systems received FDA 510(k) clearance on 2022-12-23, under approval number K223442.
What company makes MR 5300 and MR 7700 R11 MR Systems?
MR 5300 and MR 7700 R11 MR Systems is manufactured by Philips Medical Systems Nederlands B.V..
What is the FDA product code for MR 5300 and MR 7700 R11 MR Systems?
The FDA product code for MR 5300 and MR 7700 R11 MR Systems is LNH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.