Total clearances
5
2020-12-18 → 2024-11-15
Name variants in FDA filings: Ultromics Limited / Ultromics, Ltd.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| QUO |
— |
— |
— |
2 |
2024-09-23 |
| SDJ |
— |
— |
— |
1 |
2024-11-15 |
| QIH |
Automated Radiological Image Processing Software |
Class II |
Radiology |
1 |
2021-12-20 |
| POK |
— |
— |
— |
1 |
2020-12-18 |
Filings
All 510(k) clearances (5)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2024-11-15 |
K240860 |
EchoGo Amyloidosis (1.0) |
SDJ |
— |
— |
| 2024-09-23 |
K240013 |
EchoGo Heart Failure (2.0) |
QUO |
— |
— |
| 2022-11-23 |
K222463 |
EchoGo Heart Failure |
QUO |
— |
— |
| 2021-12-20 |
K213275 |
EchoGo Core (2.0) |
QIH |
Class II |
Radiology |
| 2020-12-18 |
K201555 |
EchoGo Pro |
POK |
— |
— |