The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Spectral Ct.
| Device ID | K203020 |
| 510k Number | K203020 |
| Device Name: | Spectral CT |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best, NL 5684 Pc |
| Contact | Yaara Oltchik |
| Correspondent | Yaara Oltchik 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 | 2020-10-02 |
| Decision Date | 2021-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838101111 | K203020 | 000 |