The following data is part of a premarket notification filed by Philips Medical Systems Nederland, B.v. with the FDA for Ingenia 3.0t, Ingenia 3.0t Cx, Ingenia Elition And Mr 7700 With Distributed Multi Nudclei.
Device ID | K213516 |
510k Number | K213516 |
Device Name: | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition And MR 7700 With Distributed Multi Nudclei |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | Philips Medical Systems Nederland, B.V. Veenpluis 4-6 Best, NL 5684pc |
Contact | Jan Van De Kerkhof |
Correspondent | Jan Van De Kerkhof Philips Medical Systems Nederland, B.V. Veenpluis 4-6 Best, NL 5684pc |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-11-03 |
Decision Date | 2022-03-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838104129 | K213516 | 000 |
00884838104112 | K213516 | 000 |