The following data is part of a premarket notification filed by Zebra Medical Vision Ltd. with the FDA for Healthpnx.
| Device ID | K190362 |
| 510k Number | K190362 |
| Device Name: | HealthPNX |
| Classification | Radiological Computer-assisted Prioritization Software For Lesions |
| Applicant | Zebra Medical Vision Ltd. Shefayim Commercial Center, PO Box 25 Shefayim, IL 6099000 |
| Contact | Flair Bar |
| Correspondent | Flair Bar Zebra Medical Vision Ltd. Shefayim Commercial Center, PO Box 25 Shefayim, 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 | 2019-02-15 |
| Decision Date | 2019-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290018016015 | K190362 | 000 |
| 07290018016077 | K190362 | 000 |