The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Spectral Ct On Rails.
| Device ID | K212875 |
| 510k Number | K212875 |
| Device Name: | Spectral CT On Rails |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Philips Medical Systems Nederland B.V. Veenpluis 6 BEST, NL 5684 PC |
| Contact | Maya Tolchinsky |
| Correspondent | Maya Tolchinsky Philips Medical Systems Nederland B.V. Veenpluis 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 | 2021-09-09 |
| Decision Date | 2022-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838103627 | K212875 | 000 |