The following data is part of a premarket notification filed by Skanray Technologies Private Limited with the FDA for Intraskan Dc Plus.
| Device ID | K170967 |
| 510k Number | K170967 |
| Device Name: | Intraskan DC Plus |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | Skanray Technologies Private Limited Plot 15-17, Hebbal Industrial Area Mysore, IN 570016 |
| Contact | Mahadevan J. |
| Correspondent | Parul Chansoria ELEXES Medical Consulting Pvt. Ltd 6484, Tralee Village Dt Dr Dublin, CA 94568 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-31 |
| Decision Date | 2017-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08904269400446 | K170967 | 000 |
| 08904269400477 | K170967 | 000 |
| 08904269400521 | K170967 | 000 |
| 08904269400538 | K170967 | 000 |
| 08904269400545 | K170967 | 000 |
| 08904269400552 | K170967 | 000 |
| 08904269400569 | K170967 | 000 |
| 08904269400576 | K170967 | 000 |
| 08904269400583 | K170967 | 000 |
| 08904269400590 | K170967 | 000 |
| 08904269400453 | K170967 | 000 |
| 08904269400460 | K170967 | 000 |