Syntermed, Inc.
Atlanta, GA, US
SYNTERMED, INC. appears in FDA device records in Atlanta, GA. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Syntermed, Inc. between 2000 and 2023. The busiest year on record is 2004, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2002 | 2 |
| 2004 | 3 |
| 2007 | 2 |
| 2008 | 1 |
| 2013 | 3 |
| 2018 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223422 | Emory Cardiac Toolbox 4.3 | KPS | Substantially Equivalent | |
| K180077 | NeuroQ 3.8 | KPS | Substantially Equivalent | |
| K130902 | EMORY CARDIAC TOOLBOX 3.2 | KPS | Substantially Equivalent | |
| K130451 | NEUROQ 3.6 | KPS | Substantially Equivalent | |
| K123646 | EMORY CARDIAC TOOLBOX 4.0 | KPS | Substantially Equivalent | |
| K072307 | QUANTITATIVE NEUROQ 3.0 | KPS | Substantially Equivalent | |
| K071503 | SYSTEM, TOMOGRAPHY, COMPUTED EMISSION | KPS | Substantially Equivalent | |
| K070089 | SYNTERMED LIVE | LLZ | Substantially Equivalent | |
| K042258 | BP-SPECT V1.O | KPS | Substantially Equivalent | |
| K041022 | NEUROQ - PET DP | KPS | Substantially Equivalent | |
| K040141 | EMORY CARDIAC TOOLBOX VERSION 2.6 | KPS | Substantially Equivalent | |
| K020300 | NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS) | KPS | Substantially Equivalent | |
| K014033 | EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS | KPS | Substantially Equivalent | |
| K001276 | MEDICAL IMAGE MERGE (MIM) | KPS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1066019 | 3003079232 | SYNTERMED, INC. | 333 Sandy Springs Cir NE Ste 107, Atlanta, GA 30328 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain