Data / Medical devices / United Kingdom / Ultromics, Ltd.
Ultromics, Ltd.: FDA-registered device maker in Oxford Oxfordshire, United Kingdom, 6 510(k) clearances
Ultromics, Ltd. is registered with the FDA (registration 3016585383) in Oxford Oxfordshire, United Kingdom. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 15, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016585383
- Address
- 4630 Kingsgate, Cascade Way Oxford Business Park South, Oxford Oxfordshire, United Kingdom, OX4 2SU
- Owner or operator
- Ultromics, Ltd. (10062539)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 11, 2020
- Registered through
- 2026
- Brand names listed
- EchoGo Amyloidosis (1), EchoGo Core, EchoGo Heart Failure, EchoGo Heart Failure (2), EchoGo Pro, EchoGo WorkStream (1)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adjunctive Cardiac Amyloidosis Status Indicator | SDJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Adjunctive Heart Failure Status Indicator | QUO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | POK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 15, 2024 | K240860 | EchoGo Amyloidosis (1.0) | SDJ | Substantially Equivalent | Ultromics Limited | accessdata.fda.gov |
| September 23, 2024 | K240013 | EchoGo Heart Failure (2.0) | QUO | Substantially Equivalent | Ultromics Limited | accessdata.fda.gov |
| November 23, 2022 | K222463 | EchoGo Heart Failure | QUO | Substantially Equivalent | Ultromics Limited | accessdata.fda.gov |
| December 20, 2021 | K213275 | EchoGo Core (2.0) | QIH | Substantially Equivalent | Ultromics Limited | accessdata.fda.gov |
| December 18, 2020 | K201555 | EchoGo Pro | POK | Substantially Equivalent | Ultromics, Ltd. | accessdata.fda.gov |
| November 13, 2019 | K191171 | EchoGo Core | QIH | Substantially Equivalent | Ultromics, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of Adjunctive Heart Failure Status Indicator
- All makers of Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- All makers of Automated Radiological Image Processing Software
- All makers of Adjunctive Cardiac Amyloidosis Status Indicator
Updated November 15, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.