ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
ImSonic Medical China, INC.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9680027 | 3002807317 | IMS GIOTTO S.p.A. | 1 | N | 2026-01-01 | Via Sagittario, 5 Sasso Marconi Bologna IT 40037 |
| 3007421906 | 3003459352 | IMS, INC. | 1 | Y | 2026-01-01 | 12311 S 74th E Ave Suite A Bixby OK US 74008 |
| 3009965750 | 3009965750 | IMS ENGINEERED PRODUCTS, LLC | 1 | N | 2026-01-01 | 1 INNOVATION DR Des Plaines IL US 60016 |
| 3016676354 | 3016676354 | IMS LABS, LLC | 1 | Y | 2020-04-25 | 4425 Bayard St Suite 210 San Diego CA US 92109 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 99544 | 1594765925 | K990192 | BIOPSY-DIGIT | IZH | 1999-03-12 |
| 99544 | 1816973591 | K982049 | BIOPSY M | IZH | 1998-07-14 |
| 99544 | 1917131602 | K925212 | GIOTTO PATIENT BED | IZH | 1993-01-15 |
| 99544 | 1732926472 | K203509 | SMART FINDER | IZH | 2021-07-14 |
| 99544 | 2012501061 | K200424 | Giotto Class (Models - 3000X-YY and 4000X-YY) | MUE | 2020-06-18 |
| 99544 | 1883689215 | K113607 | BIOPSY DIGIT S BIOPSY SL | IZH | 2012-08-10 |
| 99544 | 1224756249 | K111434 | GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L | MUE | 2011-10-27 |
| 155952 | 1640521206 | K031414 | POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE | LYY | 2003-06-26 |
| 99544 | 1584641950 | K012953 | GIOTTO IMAGE | IZH | 2001-11-30 |
| 167208 | 1661760598 |
ImSonic Medical China, INC.
IMS Giotto S.p.A.
IMS GIOTTO S.p.A.
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