The following data is part of a premarket notification filed by Meddiff Technologies Pvt. Ltd. with the FDA for Instarispacs / Instazfp / Instamobi V5.0.
| Device ID | K182572 |
| 510k Number | K182572 |
| Device Name: | InstaRISPACS / InstaZFP / InstaMobi V5.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Meddiff Technologies Pvt. Ltd. Salarpuria Palladium, 3rd Flor, #2021, 100 Ft Road, HAL 2ndStage Bangalore, IN 560 008 |
| Contact | Mr. Sanjeev |
| Correspondent | Carl Alletto OTech Inc 8317 Belew Drive Mckinney, TX 75071 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-18 |
| Decision Date | 2019-04-12 |