The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Precedence Spect/ct Imaging System.
Device ID | K051351 |
510k Number | K051351 |
Device Name: | PRECEDENCE SPECT/CT IMAGING SYSTEM |
Classification | System, Tomography, Computed, Emission |
Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Contact | Coleen A Coleman |
Correspondent | Morten Simon 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 | 2005-05-24 |
Decision Date | 2005-06-08 |
Summary: | summary |