The following data is part of a premarket notification filed by Philips Medical Systems Nethrlands Bv with the FDA for Philips Spectral Ct Applications.
| Device ID | K150665 |
| 510k Number | K150665 |
| Device Name: | Philips Spectral CT Applications |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | PHILIPS MEDICAL SYSTEMS NETHRLANDS BV VEENPLUIS 4-6 Best, NL 5684 Pc |
| Contact | None Provided |
| Correspondent | Susan Quick PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. 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 | 2015-03-16 |
| Decision Date | 2015-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838083653 | K150665 | 000 |
| 00884838083646 | K150665 | 000 |