Data / Medical devices / United States / Syntermed, Inc.
Syntermed, Inc.: FDA-registered device maker in Atlanta, GA, United States, 4 510(k) clearances
Syntermed, Inc. is registered with the FDA (registration 1066019) in Atlanta, GA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 30, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1066019
- FEI number
- 3003079232
- Address
- 333 Sandy Springs Cir NE Ste 107, Atlanta, GA, United States, 30328
- Owner or operator
- SYNTERMED, INC. (9041128)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 25, 2016
- Registered through
- 2027
- Brand names listed
- Emory Cardiac Toolbox, Emory Cardiac Toolbox 4.3, NeuroQ
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer, Repackager or relabeler | 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 30, 2023 | K223422 | Emory Cardiac Toolbox 4.3 | KPS | Substantially Equivalent | Syntermed | accessdata.fda.gov |
| August 16, 2018 | K180077 | NeuroQ 3.8 | KPS | Substantially Equivalent | Syntermed | accessdata.fda.gov |
| May 17, 2013 | K130451 | NEUROQ 3.6 | KPS | Substantially Equivalent | Syntermed, Inc. | accessdata.fda.gov |
| February 22, 2013 | K123646 | EMORY CARDIAC TOOLBOX 4.0 | KPS | Substantially Equivalent | Syntermed, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Tomography, Computed, Emission
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Image Processing, Radiological
Updated March 30, 2023. 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.