UltraSight AI Guidance— 510(k) K223347
Substantially EquivalentUltrasight, Inc.
FDA 510(k) clearance K223347 for UltraSight AI Guidance, Substantially Equivalent on 2023-07-24. Applicant: Ultrasight, Inc.. Device class: 2.
Clearance details
- Applicant
- Ultrasight, Inc.
- Product code
- Code QJU
- Device class
- Class 2
- Regulation
- 21 CFR 892.2100
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rehovot, IL
Recent devices under product code QJU
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