Sheeted HealX - 1
2024-09-10
SWIFT MEDICAL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3001744314 | 3001744314 | SWIFT MEDICAL | 1 | N | 2026-01-01 | 1 King Street West Suite 4800 - 355 Toronto Ontario CA M5H 1A1 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 191827 | 1930608093 | K251678 | Swift Ray 1 | QJF | 2026-02-24 |
| 191827 | 1271418326 | ||||
| 191827 | 1771300373 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QJF | 1 | 2026-02-24 |
GUDID#
HealX - 1
2019-10-04
Ray 1 - Ray 1 is a portable hyperspectral imaging tool that allows qualified healthcare professionals, to assess wounds, at the point of care: i) to capture and digitally record images of fluorescence emitted from a wound when exposed to excitation light and ii) to capture and digitally record images through measuring surface temperature distribution.
2022-04-18
Swift Vision - SV403
2021-03-15
Medline NE1® WMS - S4
2019-10-04
Healogics Photo+ - S3
2019-10-04
PointClickCare Skin and Wound - S2
2019-10-04
Swift Skin and Wound - S1
2019-10-04