The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Option U1 For The Dps-plus System.
| Device ID | K915305 |
| 510k Number | K915305 |
| Device Name: | OPTION U1 FOR THE DPS-PLUS SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Larry Hernadez |
| Correspondent | Larry Hernadez ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-21 |
| Decision Date | 1992-02-26 |