The following data is part of a premarket notification filed by Nanoxai Ltd. with the FDA for Healthost.
| Device ID | K213944 |
| 510k Number | K213944 |
| Device Name: | HealthOST |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | NanoxAI Ltd. Shefayim Commercial Center, PO Box 25 Shefayim, IL 6099000 |
| Contact | Shlomit Cymbalista |
| Correspondent | Neta Sherman NanoxAI Ltd. Shefayim Commercial Center, PO Box 25 Shefayim, IL 6099000 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-17 |
| Decision Date | 2022-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290018016114 | K213944 | 000 |
| 07290018016145 | K213944 | 000 |