The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Tomoscan Sr7000 Ct Systems.
| Device ID | K924082 |
| 510k Number | K924082 |
| Device Name: | PHILIPS TOMOSCAN SR7000 CT SYSTEMS |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL |
| Contact | Peter Altman |
| Correspondent | Peter Altman PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-13 |
| Decision Date | 1993-03-10 |