The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Quantitative Blood Pool Spect (qbs).
| Device ID | K022428 |
| 510k Number | K022428 |
| Device Name: | QUANTITATIVE BLOOD POOL SPECT (QBS) |
| Classification | System, Image Processing, Radiological |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Coleen Coleman |
| Correspondent | Michael Kwan UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-07-25 |
| Decision Date | 2002-08-06 |
| Summary: | summary |