The following data is part of a premarket notification filed by Hopkins Imaging Systems, Inc. with the FDA for Models Priam (family Of Devices) Digital Imaging System.
| Device ID | K000630 |
| 510k Number | K000630 |
| Device Name: | MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | HOPKINS IMAGING SYSTEMS, INC. 1812 FLOWER ST. Duarte, CA 91010 |
| Contact | Richard Hopkins |
| Correspondent | Richard Hopkins HOPKINS IMAGING SYSTEMS, INC. 1812 FLOWER ST. Duarte, CA 91010 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-24 |
| Decision Date | 2000-05-12 |