The following data is part of a premarket notification filed by Philips Medical Systems (cleveland), Inc. with the FDA for Iqon Spectral Ct.
| Device ID | K163711 |
| 510k Number | K163711 |
| Device Name: | IQon Spectral CT |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, OH 44143 |
| Contact | Steven Goldberg |
| Correspondent | Steven Goldberg 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 | 2016-12-30 |
| Decision Date | 2017-04-05 |
| Summary: | summary |