The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Dicom 3.0 Software Version 2.0.
| Device ID | K973239 |
| 510k Number | K973239 |
| Device Name: | DICOM 3.0 SOFTWARE VERSION 2.0 |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Dennis W Henkelman |
| Correspondent | Dennis W Henkelman ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-28 |
| Decision Date | 1997-11-26 |
| Summary: | summary |