The following data is part of a premarket notification filed by Philips Medical Systems (cleveland) Inc. with the FDA for Ingenuity Tf.
| Device ID | K172406 |
| 510k Number | K172406 |
| Device Name: | Ingenuity TF |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Philips Medical Systems (Cleveland) Inc. 595 Miner Rd Cleveland, OH 44143 |
| Contact | Christine Anderson |
| Correspondent | Christine Anderson Philips Medical Systems (Cleveland) Inc. 595 Miner Rd Cleveland, OH 44143 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-09 |
| Decision Date | 2017-10-06 |
| Summary: | summary |