The following data is part of a premarket notification filed by Philips Healthcare (cleveland) with the FDA for Ingenuity Tf Pet/mr.
| Device ID | K103483 |
| 510k Number | K103483 |
| Device Name: | INGENUITY TF PET/MR |
| Classification | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Applicant | PHILIPS HEALTHCARE (CLEVELAND) 595 MINER RD. Cleveland, OH 44143 |
| Contact | Eduard Toerek |
| Correspondent | Eduard Toerek PHILIPS HEALTHCARE (CLEVELAND) 595 MINER RD. Cleveland, OH 44143 |
| Product Code | OUO |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2010-11-26 |
| Decision Date | 2011-11-23 |
| Summary: | summary |