Arterys Software v2.0
FDA 510(k) K162513 · Arterys, Inc.
510(k) numberK162513
Submission
- Device name
- Arterys Software v2.0
- Applicant
- Arterys, Inc.
San Francisco, CA, US - Received
- September 8, 2016
- Decision date
- October 28, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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More from Avara Software
| 510(k) | Device | Decision |
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| K252539 | Tempus PixelQIH · Special | 09/03/2025SE |
| K203744 | Arterys MICAQIH · Traditional | 03/14/2022SE |
| K192437 | Arterys MICAQIH · Traditional | 03/25/2020SE |
| K182034 | Arterys MICALLZ · Traditional | 10/17/2018SE |
| K173542 | Arterys Oncology DLLLZ · Traditional | 01/25/2018SE |
| K171544 | Arterys ViewerLLZ · Traditional | 07/18/2017SE |
| K163253 | Arterys Cardio DLLLZ · Traditional | 01/05/2017SE |
Questions and answers
When was Arterys Software v2.0 cleared by the FDA?
Arterys Software v2.0 (K162513) received a 510(k) decision of Substantially Equivalent on October 28, 2016, 50 days after the submission was received.
What is the product code of K162513?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.