The following data is part of a premarket notification filed by Datacom Technology Corp. with the FDA for Datacom Dc Pacs.
| Device ID | K083182 |
| 510k Number | K083182 |
| Device Name: | DATACOM DC PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | DATACOM TECHNOLOGY CORP. NO.58, FU CHIUN STREET Hsin Chu City Tw-hsq Taiwan, CN 30067 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min DATACOM TECHNOLOGY CORP. NO.58, FU CHIUN STREET Hsin Chu City Tw-hsq Taiwan, CN 30067 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-28 |
| Decision Date | 2009-03-04 |
| Summary: | summary |