The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Adac Model Dps-3300m Digital Processing System.
Device ID | K844298 |
510k Number | K844298 |
Device Name: | ADAC MODEL DPS-3300M DIGITAL PROCESSING SYSTEM |
Classification | System, Image Processing, Radiological |
Applicant | ADAC LABORATORIES 255 SAN GERONIMO WAY Sunnvale, CA 94086 |
Contact | Rebecca Anderson |
Correspondent | Rebecca Anderson ADAC LABORATORIES 255 SAN GERONIMO WAY Sunnvale, CA 94086 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-30 |
Decision Date | 1985-03-01 |