The following data is part of a premarket notification filed by Zebra Medical Vision Ltd. with the FDA for Healthjoint.
| Device ID | K202487 |
| 510k Number | K202487 |
| Device Name: | HealthJOINT |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-31 |
| Decision Date | 2020-12-04 |