Data / Medical devices / United Kingdom / Danelis Medical Limited
Danelis Medical Limited: FDA-registered device maker in Rhayader Powys, United Kingdom, 15 510(k) clearances
Danelis Medical Limited is registered with the FDA (registration 3013844297) in Rhayader Powys, United Kingdom. It lists 7 device types. The FDA files 15 510(k) clearances under its listings, the newest dated July 22, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013844297
- Address
- The Hollies Bryngwy, Rhayader Powys, United Kingdom, LD6 5BN
- Owner or operator
- Danelis Medical Limited (10061863)
- Roles
- Exporter to the US
- First device listed
- November 26, 2019
- Registered through
- 2026
- Brand names listed
- 6VT-D, BK5000, Canon Aplio i series, GE LOGIQ E9 LOGIQ E9 XDClear 2, HM70A, LOGIQ E10, MTurbo, Noblus and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Exporter to the US | accessdata.fda.gov |
| Biopsy Needle Guide Kit | OIJ | 2 | Exporter to the US | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Exporter to the US | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Exporter to the US | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Exporter to the US | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Exporter to the US | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| July 22, 2024 | K240704 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 11, 2023 | K223830 | Ultrasound System 2300 | IYN | Substantially Equivalent | Bk Medical Aps | accessdata.fda.gov |
| July 19, 2019 | K191467 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 | IYN | Substantially Equivalent | Canon Medical Systems Corporation | accessdata.fda.gov |
| December 20, 2017 | K173555 | LOGIQ E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| October 4, 2017 | K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| November 17, 2016 | K163077 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| December 21, 2015 | K153408 | HM70A Diagnostic Ultrasound System | IYN | Substantially Equivalent | Samsung Medison Co., Ltd. | accessdata.fda.gov |
| August 19, 2015 | K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| August 12, 2015 | K151663 | RS80A Diagnostic Ultrasound System | IYN | Substantially Equivalent | Samsung Medison Co., Ltd. | accessdata.fda.gov |
| July 9, 2015 | K151451 | Aplio 500/400/300 Diagnostic Ultrasound System V6.0 | IYN | Substantially Equivalent | Toshibamedical Systems Corporation | accessdata.fda.gov |
| January 14, 2015 | K142368 | NOBLUS DIAGNOSTIC ULTRASOUND SCANNER | IYN | Substantially Equivalent | Hitachi Aloka Medical, Ltd. | accessdata.fda.gov |
| May 15, 2014 | K141093 | 6VT-D ULTRASOUND TRANSDUCER | ITX | Substantially Equivalent | Ge Vingmed Ultrasound AS | accessdata.fda.gov |
| March 25, 2013 | K130173 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | IYN | Substantially Equivalent | FUJIFILM Sonosite, Inc. | accessdata.fda.gov |
| December 22, 2008 | K081148 | SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER | IYO | Substantially Equivalent | Siemens Medical Solutions USA, Inc., Ultrasound DI | accessdata.fda.gov |
| July 11, 2008 | K081802 | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | ITX | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Automated Radiological Image Processing Software
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Biopsy Needle Guide Kit
Updated July 22, 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.