# Ultromics Limited

- Location (FDA's records): Oxford, GB
- FDA decisions: 6 (2019–2024): 6 510(k) clearances
- Names in FDA's records: Ultromics Limited (4); Ultromics, Ltd. (2)
- Product codes: QIH (2), QUO (2), POK (1), SDJ (1)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 14 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tomtec Imaging Systems GmbH: 1 (https://510kreport.com/company/tomtec-imaging-systems)
- Koios Medical, Inc.: 1 (https://510kreport.com/company/koios-medical)
- Etiometry, Inc.: 1 (https://510kreport.com/company/etiometry)

## Firms that cite its devices most
- Aisap: 2 (https://510kreport.com/company/aisap)
- InVision Medical Technology Corporation: 1 (https://510kreport.com/company/invision-medical-technology)
- Echo IQ, Ltd.: 1 (https://510kreport.com/company/echo-iq)
- Icardio.Ai: 1 (https://510kreport.com/company/icardio-ai)
- Eko.Ai Pte Ltd. D/B/A Us2.Ai: 1 (https://510kreport.com/company/eko-ai-d-b-a-us2-ai)
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC: 1 (https://510kreport.com/company/ge-medical-systems-ultrasound-primary-care-diagnostics)
- Avicena, LLC: 1 (https://510kreport.com/company/avicena)
- Mycardium AI Limited: 1 (https://510kreport.com/company/mycardium-ai)

## Its most-cited devices
- K222463: EchoGo Heart Failure (2022), cited by 5
- K201555: EchoGo Pro (2020), cited by 4
- K191171: EchoGo Core (2019), cited by 2
- K240860: EchoGo Amyloidosis (1.0) (2024), cited by 2
- K213275: EchoGo Core (2.0) (2021), cited by 1

## Recent decisions
- K240860: EchoGo Amyloidosis (1.0) (Nov 15, 2024)
- K240013: EchoGo Heart Failure (2.0) (Sep 23, 2024)
- K222463: EchoGo Heart Failure (Nov 23, 2022)
- K213275: EchoGo Core (2.0) (Dec 20, 2021)
- K201555: EchoGo Pro (Dec 18, 2020)
- K191171: EchoGo Core (Nov 13, 2019)

Source page: https://510kreport.com/company/ultromics
