ARTIS pheno
FDA 510(k) K163286 · Siemens Medical Solution USA, Inc.
510(k) numberK163286
Submission
- Device name
- ARTIS pheno
- Applicant
- Siemens Medical Solution USA, Inc.
Malvern, PA, US - Received
- November 22, 2016
- Decision date
- March 9, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K253726 | uAngio AVIVA CXOWB · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 08/21/2026SE |
| K261413 | Extron 3;EXTRON 6OWB · Traditional | DRTECH Corporation | 08/19/2026SE |
| K254205 | Zenition 30OWB · Traditional | Philips Medical Systems Nederland B.V. | 08/07/2026SE |
| K260607 | Shield System (Siemens 30x40)OWB · Special | Radiaction , Ltd. | 07/31/2026SE |
| K253670 | SmartCT (R3.0 (L10))OWB · Abbreviated | Philips Medical Systems B.V. | 07/10/2026SE |
| K252735 | C-beamOWB · Traditional | Pulmera, Inc. | 05/22/2026SE |
| K252503 | Intelligent NROWB · Traditional | Canon, Inc. | 04/30/2026SE |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional | Siemens Medical Solutions USA, Inc. | 04/24/2026SE |
| K253752 | ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional | Siemens Medical Solutions USA, Inc. | 04/23/2026SE |
| K252229 | Belliger AceOWB · Traditional | Genoray Co., Ltd. | 04/02/2026SE |
More from Genoray Co., Ltd.
| 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 |
| K163285 | syngo Application SoftwareLLZ · Traditional | 02/14/2017SE |
Questions and answers
When was ARTIS pheno cleared by the FDA?
ARTIS pheno (K163286) received a 510(k) decision of Substantially Equivalent on March 9, 2017, 107 days after the submission was received.
What is the product code of K163286?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.