The following data is part of a premarket notification filed by Dia Imaging Analysis Ltd with the FDA for Lvivo Seamless.
Device ID | K202546 |
510k Number | K202546 |
Device Name: | LVivo Seamless |
Classification | Automated Radiological Image Processing Software |
Applicant | DiA Imaging Analysis Ltd 77 Haenergia Street Beer-Sheva, IL 8470912 |
Contact | Michal Yaacobi |
Correspondent | George Hattub Medicsense USA 291 Hillside Avenue Somerset, MA 02726 |
Product Code | QIH |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-02 |
Decision Date | 2020-09-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290019352020 | K202546 | 000 |
07290019352006 | K202546 | 000 |