The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Digital Processing System.
Device ID | K840052 |
510k Number | K840052 |
Device Name: | DIGITAL PROCESSING SYSTEM |
Classification | Camera, Scintillation (gamma) |
Applicant | ADAC LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IYX |
CFR Regulation Number | 892.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-06 |
Decision Date | 1984-03-22 |