The following data is part of a premarket notification filed by Philips Medical Systems, Nederland B.v. with the FDA for Iqon Spectral Ct.
| Device ID | K193454 |
| 510k Number | K193454 |
| Device Name: | IQon Spectral CT |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Philips Medical Systems, Nederland B.V. Veenpluis 4-6 Best, NL 5684 Pc |
| Contact | Nimit Shah |
| Correspondent | Nimit Shah Philips Medical Systems, Nederland B.V. Veenpluis 4-6 Best, NL 5684 Pc |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-13 |
| Decision Date | 2020-01-24 |