The following data is part of a premarket notification filed by Philips Medical Systems (cleveland), Inc. with the FDA for Philips Ingenuity Ct.
| Device ID | K160743 |
| 510k Number | K160743 |
| Device Name: | Philips Ingenuity CT |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Philips Medical Systems (Cleveland), Inc. 595 Miner Rd Cleveland, OH 44143 |
| Contact | Susan Quick |
| Correspondent | Susan Quick Philips Medical Systems (Cleveland), Inc. 595 Miner Rd Cleveland, OH 44143 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-17 |
| Decision Date | 2016-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838059511 | K160743 | 000 |
| 00884838059504 | K160743 | 000 |
| 00884838059498 | K160743 | 000 |