The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Digital Radiography Sys-dps7100.
Device ID | K834287 |
510k Number | K834287 |
Device Name: | DIGITAL RADIOGRAPHY SYS-DPS7100 |
Classification | System, X-ray, Fluoroscopic, Image-intensified |
Applicant | ADAC LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JAA |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-25 |
Decision Date | 1984-01-10 |