SURGIVISIO Device
FDA 510(k) K220627 · Ecential Robotics
510(k) numberK220627
Submission
- Device name
- SURGIVISIO Device
- Applicant
- Ecential Robotics
Gieres, FR - Received
- March 4, 2022
- Decision date
- March 18, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code OWB
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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 |
|---|---|---|
| K261113 | Op.n Spine Navigation and Robotic GuidanceOLO · Traditional | 07/22/2026SE |
| K242914 | Op.n(TM) NavigationOLO · Traditional | 03/07/2025SE |
| K233228 | Spine Navigation and Robotic-Assistance DeviceOLO · Traditional | 06/14/2024SE |
| K231886 | SURGIVISIO DeviceOLO · Special | 07/27/2023SE |
| K221028 | SURGIVISIO DeviceOLO · Traditional | 07/06/2022SE |
| K220946 | SURGIVISIO DeviceOWB · Special | 04/15/2022SE |
Questions and answers
When was SURGIVISIO Device cleared by the FDA?
SURGIVISIO Device (K220627) received a 510(k) decision of Substantially Equivalent on March 18, 2022, 14 days after the submission was received.
What is the product code of K220627?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.