ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno
FDA 510(k) K254173 · Siemens Medical Solutions USA, Inc.
510(k) numberK254173
Submission
- Device name
- ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno
- Applicant
- Siemens Medical Solutions USA, Inc.
Malvern, PA, US - Received
- December 23, 2025
- Decision date
- April 24, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K252503 | Intelligent NROWB · Traditional | Canon, Inc. | 04/30/2026SE |
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| K252229 | Belliger AceOWB · Traditional | Genoray Co., Ltd. | 04/02/2026SE |
| K252099 | TriniasOWB · Abbreviated | Shimadzu Corporation | 03/24/2026SE |
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| K254184 | syngo Application SoftwareQIH · Traditional | 04/29/2026SE |
| K253752 | ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional | 04/23/2026SE |
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| K254016 | MI View&GOQIH · Special | 02/10/2026SE |
Questions and answers
When was ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno cleared by the FDA?
ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (K254173) received a 510(k) decision of Substantially Equivalent on April 24, 2026, 122 days after the submission was received.
What is the product code of K254173?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.