syngo Application Software
FDA 510(k) K163285 · Siemens Medical Solution USA, Inc.
510(k) numberK163285
Submission
- Device name
- syngo Application Software
- Applicant
- Siemens Medical Solution USA, Inc.
Malvern, PA, US - Received
- November 22, 2016
- Decision date
- February 14, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Avara Software
| 510(k) | Device | Decision |
|---|---|---|
| K220433 | syngo Application Software (VE21)LLZ · Traditional | 08/16/2022SE |
| K201156 | ARTIS pheno (VE2)OWB · Traditional | 06/29/2020SE |
| K193178 | Biograph HorizonKPS · Traditional | 02/12/2020SE |
| K190780 | syngo Application SoftwareLLZ · Traditional | 09/12/2019SE |
| K190757 | MAGNETOM Avanto FitLNH · Traditional | 05/31/2019SE |
| K181407 | Artis zee/zeego & Artis Q/Q.zenOWB · Traditional | 08/15/2018SE |
| K163286 | ARTIS phenoOWB · Traditional | 03/09/2017SE |
Questions and answers
When was syngo Application Software cleared by the FDA?
syngo Application Software (K163285) received a 510(k) decision of Substantially Equivalent on February 14, 2017, 84 days after the submission was received.
What is the product code of K163285?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.