Shield System (Siemens 30x40)
FDA 510(k) K260607 · Radiaction , Ltd.
510(k) numberK260607
Submission
- Device name
- Shield System (Siemens 30x40)
- Applicant
- Radiaction , Ltd.
Tel Aviv, IL - Received
- February 24, 2026
- Decision date
- July 31, 2026
- 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 |
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| K253670 | SmartCT (R3.0 (L10))OWB · Abbreviated | Philips Medical Systems B.V. | 07/10/2026SE |
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| 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 |
| K252099 | TriniasOWB · Abbreviated | Shimadzu Corporation | 03/24/2026SE |
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Questions and answers
When was Shield System (Siemens 30x40) cleared by the FDA?
Shield System (Siemens 30x40) (K260607) received a 510(k) decision of Substantially Equivalent on July 31, 2026, 157 days after the submission was received.
What is the product code of K260607?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.