The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Ultra-high Energy General Purpose Collimator (uhgp) [for Cardiac Imaging].
| Device ID | K031872 |
| 510k Number | K031872 |
| Device Name: | ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING] |
| Classification | System, Tomography, Computed, Emission |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Charlene Brumbaugh |
| Correspondent | Morten Christensen UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-06-17 |
| Decision Date | 2003-06-20 |
| Summary: | summary |