XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0
FDA 510(k) K181415 · Canon Medical Systems Corporation
510(k) numberK181415
Submission
- Device name
- XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0
- Applicant
- Canon Medical Systems Corporation
Otawara-Shi, JP - Received
- May 30, 2018
- Decision date
- September 10, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Genoray Co., Ltd.
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| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)OWB · Traditional | 03/10/2026SE |
| K253597 | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemIYN · Traditional | 01/20/2026SE |
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| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingOWB · Traditional | 10/10/2025SE |
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…JAK · Traditional | 09/26/2025SE |
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…LNH · Traditional | 07/22/2025SE |
Questions and answers
When was XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 cleared by the FDA?
XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 (K181415) received a 510(k) decision of Substantially Equivalent on September 10, 2018, 103 days after the submission was received.
What is the product code of K181415?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.