Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
FDA 510(k) K251397 · Philips Medical Systems Nederland B.V.
510(k) numberK251397
Submission
- Device name
- Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
- Applicant
- Philips Medical Systems Nederland B.V.
Best, NL - Received
- May 6, 2025
- Decision date
- June 4, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System cleared by the FDA?
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System (K251397) received a 510(k) decision of Substantially Equivalent on June 4, 2025, 29 days after the submission was received.
What is the product code of K251397?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.