The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Skylight Imaging System.
| Device ID | K000908 |
| 510k Number | K000908 |
| Device Name: | SKYLIGHT IMAGING SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Janice E Brown |
| Correspondent | Reiner Krumme TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-03-21 |
| Decision Date | 2000-04-05 |