The following data is part of a premarket notification filed by Skanray Technologies Limited with the FDA for Skanmobile, Skanmobile-dr.
| Device ID | K212940 |
| 510k Number | K212940 |
| Device Name: | Skanmobile, Skanmobile-Dr |
| Classification | System, X-ray, Mobile |
| Applicant | Skanray Technologies Limited Plot# 15-17, Hebbal Industrial Area,Hebbal Mysore, IN 570016 |
| Contact | Vasundhara R |
| Correspondent | Ankur Naik IZiel Healthcare 14, Hadapsar Industrial Estate, Hadapsar Pune, IN 411013 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-15 |
| Decision Date | 2022-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08904269403683 | K212940 | 000 |
| 08904269403522 | K212940 | 000 |