510(k) K251416
- Device
- UltraSight Guidance
- Applicant
- Ultrasight , Ltd.
- 510(k) number
- K251416
- Product code
- QJU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-17
- Date received
- 2025-05-07
- Regulation
- 892.2100
- Classification name
- Image Acquisition And/Or Optimization Guided By Artificial Intelligence
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Noa Avisar
- Address
- 8 Pinhas St. Ness Ziona IL 7403631 7403631
FDA Registration Numbers
- 3040362673
- 3032008018
- 3029923647
Source Documents
Other 510(k) Records For Product Code QJU
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242807 | HeartFocus (V.1.1.1) | Deski | 2025-04-04 |
| K243065 | Cardiac Guidance | Caption Health, Inc. | 2025-01-15 |
| K223347 | UltraSight AI Guidance | Ultrasight, Inc. | 2023-07-24 |
| K201992 | Caption Guidance | Caption Health | 2020-09-18 |
| K200755 | Caption Guidance | Caption Health | 2020-04-16 |
| DEN190040 | Caption Guidance | Bay Labs, Inc. | 2020-02-07 |