The following data is part of a premarket notification filed by Prognosys Medical Systems Private Limited with the FDA for Prorad 2fc And Prorad 3nc Stationary Radiographic Systems.
| Device ID | K183541 |
| 510k Number | K183541 |
| Device Name: | ProRad 2FC And ProRad 3NC Stationary Radiographic Systems |
| Classification | System, X-ray, Stationary |
| Applicant | Prognosys Medical Systems Private Limited No. 249, Ground Floor, Front Building, 4th Main Road, Chamrajpet Bangalore, IN 560018 |
| Contact | V. Krishna Prasad |
| Correspondent | Shruti Sancheti IZiel Healthcare 14, Hadapsar Industrial Estate, Hadapsar Pune, IN 411013 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-20 |
| Decision Date | 2019-01-24 |
| Summary: | summary |