The following data is part of a premarket notification filed by Zebra Medical Vision Ltd. with the FDA for Healthppt.
| Device ID | K211803 |
| 510k Number | K211803 |
| Device Name: | HealthPPT |
| Classification | Radiological Computer-assisted Prioritization Software For Lesions |
| Applicant | Zebra Medical Vision Ltd. Shefayim Commercial Center, PO Box 25 Sefayim, IL 6099000 |
| Contact | Shlomit Cymbalista |
| Correspondent | Shlomit Cymbalista Zebra Medical Vision Ltd. Shefayim Commercial Center, PO Box 25 Sefayim, IL 6099000 |
| Product Code | QFM |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-11 |
| Decision Date | 2021-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290018016107 | K211803 | 000 |