The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Plus Computed Tomography System.
| Device ID | K033326 |
| 510k Number | K033326 |
| Device Name: | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 595 MINER RD. Highland Hgts., OH 44143 |
| Contact | Robert L Turocy |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-10-16 |
| Decision Date | 2003-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838083325 | K033326 | 000 |
| 00884838059528 | K033326 | 000 |