Data / Medical devices / Singapore / 20med Pte Ltd
20med Pte Ltd: FDA-registered device maker in Singapore Central Singapore, Singapore, 11 510(k) clearances
20med Pte Ltd is registered with the FDA (registration 3026047529) in Singapore Central Singapore, Singapore. It lists 9 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 28, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026047529
- Address
- #09-01 20 Collyer Quay, Singapore Central Singapore, Singapore, 049319
- Owner or operator
- 20MED PTE LTD (10087046)
- Roles
- Exporter to the US
- First device listed
- January 5, 2023
- Registered through
- 2026
- Brand names listed
- 20MED CT1, 20MED CT2, 20MED CT3, 20MED CT4, 20MED MR1, 20MED MR2, 20MED MR3, 20MED MR4 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 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 |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Exporter to the US | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | 2 | Exporter to the US | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Exporter to the US | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 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 |
|---|---|---|---|---|---|---|
| March 28, 2022 | K212889 | Syngo.CT Dual Energy | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 10, 2020 | K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| February 14, 2020 | K193248 | Biograph Vision, Biograph mCT Family of PET/CTs | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 12, 2019 | K191050 | MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 15, 2019 | K183548 | SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 6, 2018 | K181613 | MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 27, 2018 | K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| April 4, 2018 | K173079 | Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| March 21, 2014 | K133657 | DISCOVERY PET/CT 710 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 30, 2013 | K131576 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 20, 2012 | K121676 | 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of System, Tomography, Computed, Emission
- All makers of System, Nuclear Magnetic Resonance Spectroscopic
- All makers of Coil, Magnetic Resonance, Specialty
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
Updated March 28, 2022. 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.