MR 5300 and MR 7700 R11 MR Systems
FDA 510(k) K223442 · Philips Medical Systems Nederlands B.V.
510(k) numberK223442
Submission
- Device name
- MR 5300 and MR 7700 R11 MR Systems
- Applicant
- Philips Medical Systems Nederlands B.V.
Best, NL - Received
- November 14, 2022
- Decision date
- December 23, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MR 5300 and MR 7700 R11 MR Systems cleared by the FDA?
MR 5300 and MR 7700 R11 MR Systems (K223442) received a 510(k) decision of Substantially Equivalent on December 23, 2022, 39 days after the submission was received.
What is the product code of K223442?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.