The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Gemini Imaging System.
Device ID | K013521 |
510k Number | K013521 |
Device Name: | GEMINI IMAGING SYSTEM |
Classification | System, X-ray, Tomography, Computed |
Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Contact | Coleen A Coleman |
Correspondent | Michael Kwan UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2001-10-23 |
Decision Date | 2001-11-07 |
Summary: | summary |