The following data is part of a premarket notification filed by Philips Medical Systems, Nederlands B.v. with the FDA for Ingenia 1.5t And Ingenia 1.5t S R5.2.
| Device ID | K153324 |
| 510k Number | K153324 |
| Device Name: | Ingenia 1.5T And Ingenia 1.5T S R5.2 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS, NEDERLANDS B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
| Contact | Henrie Daniels |
| Correspondent | Henrie Daniels PHILIPS MEDICAL SYSTEMS, NEDERLANDS B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-18 |
| Decision Date | 2016-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838068421 | K153324 | 000 |
| 00884838055322 | K153324 | 000 |
| 00884838009820 | K153324 | 000 |