UltraSight AI Guidance
FDA 510(k) clearance K223347 · decided 2023-07-24
Clearance details
- K-number
- K223347
- Device name
- UltraSight AI Guidance
- Applicant
- Ultrasight, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-11-01
- Decision date
- 2023-07-24
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- QJU
- Device class
- 2
- Regulation number
- 892.2100
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Rehovot, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ThinkSono Guidance (K260338) | ThinkSono GmbH | 2026-07-15 |
| HeartFocus (K260780) | Deski | 2026-06-03 |
| UltraSight Guidance (K251416) | Ultrasight , Ltd. | 2025-12-17 |
| HeartFocus (V.1.1.1) (K242807) | Deski | 2025-04-04 |
| Cardiac Guidance (K243065) | Caption Health, Inc. | 2025-01-15 |
| Caption Guidance (K201992) | Caption Health | 2020-09-18 |
| Caption Guidance (K200755) | Caption Health | 2020-04-16 |
| Caption Guidance (DEN190040) | Bay Labs, Inc. | 2020-02-07 |
Recalls involving this device
No recalls on record reference this clearance.