Swift Ray 1— 510(k) K251678
Substantially EquivalentSwift Medical, Inc.
FDA 510(k) clearance K251678 for Swift Ray 1, Substantially Equivalent on 2026-02-24. Applicant: Swift Medical, Inc.. Device class: 2.
Summary
Swift Medical's Swift Ray 1 is filed under product code QJF (Autofluorescence Imaging Adjunct Tool For Wounds). Beyond the name and that code name, the record gives no description.
Class II, 21 CFR 878.4550. General, Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).
Swift Medical filed from Toronto, Canada. FDA found it substantially equivalent 270 calendar days after receipt (May 30, 2025 to February 24, 2026).
Clearance details
- Applicant
- Swift Medical, Inc.
- Product code
- Product code QJF
- Device class
- Class 2
- Regulation
- 21 CFR 878.4550
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Toronto, CA
Recent devices under product code QJF
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