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 |