Persona C HR
FDA 510(k) K250282 · A.T.S. Applicazione Tecnologie Speciali S.R.L.
510(k) numberK250282
Submission
- Device name
- Persona C HR
- Applicant
- A.T.S. Applicazione Tecnologie Speciali S.R.L.
Torre De' Roveri, IT - Received
- January 31, 2025
- Decision date
- April 30, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
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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 |
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Questions and answers
When was Persona C HR cleared by the FDA?
Persona C HR (K250282) received a 510(k) decision of Substantially Equivalent on April 30, 2025, 89 days after the submission was received.
What is the product code of K250282?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.