The following data is part of a premarket notification filed by Zebra Medical Vision, Ltd. with the FDA for Healthcxr.
| Device ID | K192320 |
| 510k Number | K192320 |
| Device Name: | HealthCXR |
| 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 | 2019-08-26 |
| Decision Date | 2019-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290018016046 | K192320 | 000 |