The following data is part of a premarket notification filed by Dome Imaging Systems, Inc. with the FDA for Pacscache.
| Device ID | K983815 |
| 510k Number | K983815 |
| Device Name: | PACSCACHE |
| Classification | System, Image Processing, Radiological |
| Applicant | DOME IMAGING SYSTEMS, INC. 400 FIFTH AVENUE Waltham, MA 02451 |
| Contact | Morteza Minaee |
| Correspondent | Morteza Minaee DOME IMAGING SYSTEMS, INC. 400 FIFTH AVENUE Waltham, MA 02451 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-28 |
| Decision Date | 1999-01-14 |
| Summary: | summary |