The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Adac Dps-4070 Digital Radiography Sys.
Device ID | K843708 |
510k Number | K843708 |
Device Name: | ADAC DPS-4070 DIGITAL RADIOGRAPHY SYS |
Classification | System, Image Processing, Radiological |
Applicant | ADAC LABORATORIES 4747 HELLYER AVENUE San Jose , CA 95138 - |
Contact | Rebecca Andersen |
Correspondent | Rebecca Andersen ADAC LABORATORIES 4747 HELLYER AVENUE San Jose , CA 95138 - |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-21 |
Decision Date | 1985-04-16 |