The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Autoquant Quantitative Perfusion Spect (qps) & Quantitative Gated Spect (qgs).
| Device ID | K980715 |
| 510k Number | K980715 |
| Device Name: | AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS) |
| Classification | System, Tomography, Computed, Emission |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Dennis W Henkelman |
| Correspondent | Dennis W Henkelman ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-24 |
| Decision Date | 1998-05-06 |
| Summary: | summary |