CLISIS SYSTEMS, Discovery RF180
FDA 510(k) K213081 · General Medical Merate S.P.A
510(k) numberK213081
Submission
- Device name
- CLISIS SYSTEMS, Discovery RF180
- Applicant
- General Medical Merate S.P.A
Seriate, IT - Received
- September 23, 2021
- Decision date
- October 26, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Fujifilm Medical System U.S.A., Inc.
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Questions and answers
When was CLISIS SYSTEMS, Discovery RF180 cleared by the FDA?
CLISIS SYSTEMS, Discovery RF180 (K213081) received a 510(k) decision of Substantially Equivalent on October 26, 2021, 33 days after the submission was received.
What is the product code of K213081?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.