The following data is part of a premarket notification filed by Philips Medical Systems (cleveland) Inc. with the FDA for Philips Ct Big Bore.
| Device ID | K171850 |
| 510k Number | K171850 |
| Device Name: | Philips CT Big Bore |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Philips Medical Systems (Cleveland) Inc. 595 Miner Road Cleveland, OH 44143 |
| Contact | Michael Chilbert |
| Correspondent | Michael Chilbert Philips Medical Systems (Cleveland) Inc. 595 Miner Road 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 | 2017-06-21 |
| Decision Date | 2017-11-09 |
| Summary: | summary |