The following data is part of a premarket notification filed by Sobha Renaissance Information Technology Pvt Ltd with the FDA for Rchive Pacs.
| Device ID | K063253 |
| 510k Number | K063253 |
| Device Name: | RCHIVE PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | SOBHA RENAISSANCE INFORMATION TECHNOLOGY PVT LTD 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto SOBHA RENAISSANCE INFORMATION TECHNOLOGY PVT LTD 1600 MANCHESTER WAY Corinth, TX 76210 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-27 |
| Decision Date | 2006-12-12 |
| Summary: | summary |