ART.1-US— 510(k) K253078
Substantially EquivalentSeetreat Pty, Ltd.
FDA 510(k) clearance K253078 for ART.1-US, Substantially Equivalent on 2026-05-14. Applicant: Seetreat Pty, Ltd.. Device class: 2.
Clearance details
- Applicant
- Seetreat Pty, Ltd.
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sydney, AU
Recent devices under product code MUJ
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