U-Lite PRO
Sonoscanner Sarl
SONOSCANNER
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011688715 | 3011688715 | SONOSCANNER SARL | 1 | N | 2026-01-01 | 6 rue Andre Voguet Ivry-sur-Seine Val-de-Marne FR 94200 |
| 3012229717 | 3012229717 | SONOSCANNER US, LLC | 1 | Y | 2026-01-01 | 16192 Coastal Hwy Lewes DE US 19958 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 182835 | 1074828443 | K232285 | U-Lite PRO | IYN | 2024-01-11 |
| 182835 | 1395048361 | K201988 | T-Lite | IYN | 2020-10-30 |
| 182835 | 1147226148 | K171164 | U-Lite EXP | IYN | 2017-08-03 |
| 182835 | 2016606408 | K143601 | U-Lite | IYN | 2015-03-18 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| IYN | 4 | 2024-01-11 |
PMN#
GUDID#
T Lite - Handheld Ultrasound Scanner T Lite Pro with exchangeables probes
2025-04-17
U Lite - Handheld Ultrasound Scanner U Lite Pro with exchangeables probes
2024-01-16
U Lite - Handheld Ultrasound Scanner U Lite Pro with exchangeables probes
2024-11-18
T-Lite - Handheld Ultrasound Scanner T-Lite with exchangeable probes
2020-11-20
T-Lite - Convex Access probe 2-5Mhz
2020-11-20
T-Lite - Linear Access Probe 5-12.5 Mhz
2020-11-20
T-Lite - MicroConvex Probe R15 4-9Mhz
2020-11-20
T-Lite - Single Crystal Convex Probe 1.5-6Mhz
2020-11-20
T-Lite - Hockey Stick Probe 10-18Mhz
2020-11-20
U-Lite - SCP
2016-12-01
U-Lite - SLP
2016-12-01
U-Lite - SPA
2016-12-01
U-Lite - SEP
2016-12-01
U-Lite - Handheld Ultrasound Scanner with exchangeable probes
2018-04-06
U-Lite - Convex Probe 2-5Mhz
2018-04-06
U-Lite - Linear Probe 10-18Mhz
2018-04-06
U-Lite - Linear Probe 6-18Mhz
2018-04-06
U-Lite - Endocavitary Probe 4-9 Mhz
2018-04-06
U-Lite - Phased Array Probe 1.5-4 Mhz
2018-04-06
U-Lite - Microconvex Probe 4-9 Mhz
2018-04-06