The following data is part of a premarket notification filed by Real View Imaging Ltd. with the FDA for Holoscope-i.
| Device ID | K210072 |
| 510k Number | K210072 |
| Device Name: | HOLOSCOPE-i |
| Classification | System, Image Processing, Radiological |
| Applicant | Real View Imaging Ltd. 4 Hatnufa St. Yokneam, IL 2069202 |
| Contact | Yehudit Kraizer |
| Correspondent | Yehudit Kraizer Real View Imaging Ltd. 4 Hatnufa St. Yokneam, IL 2069202 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-11 |
| Decision Date | 2021-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290018862018 | K210072 | 000 |