The following data is part of a premarket notification filed by Meddiff Technologies Pvt. Ltd with the FDA for Instapacs/instarispacs.
| Device ID | K120718 |
| 510k Number | K120718 |
| Device Name: | INSTAPACS/INSTARISPACS |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDDIFF TECHNOLOGIES PVT. LTD 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto MEDDIFF TECHNOLOGIES PVT. LTD 1600 MANCHESTER WAY Corinth, TX 76210 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-08 |
| Decision Date | 2012-04-19 |
| Summary: | summary |