The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Dps-3300 Micro Nuclear Medicine Imaging Computer.
Device ID | K844783 |
510k Number | K844783 |
Device Name: | DPS-3300 MICRO NUCLEAR MEDICINE IMAGING COMPUTER |
Classification | System, Image Processing, Radiological |
Applicant | ADAC LABORATORIES 255 SAN GERONIMO WAY Sunnvale, CA 94086 |
Contact | Rebecca Andersen |
Correspondent | Rebecca Andersen 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 | 1984-12-10 |
Decision Date | 1985-02-01 |