Planmed Clarity 2D, Planmed Clarify S
FDA 510(k) K211720 · Planmed OY
510(k) numberK211720
Submission
- Device name
- Planmed Clarity 2D, Planmed Clarify S
- Applicant
- Planmed OY
Helsinki, FI - Received
- June 4, 2021
- Decision date
- July 18, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Fujifilm Corporation
| 510(k) | Device | Decision |
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| K250318 | Planmed XFISFV · Traditional | 09/26/2025SE |
| K213278 | Planmed VerityOAS · Traditional | 04/28/2022SE |
| K192317 | Planmed Clarity 2D and Clarity SMUE · Traditional | 10/23/2020SE |
| K180918 | Planmed VerityOAS · Traditional | 11/30/2018SE |
| K163328 | Planmed ClarityMUE · Traditional | 12/28/2017SE |
| K143435 | Planmed VerityOAS · Traditional | 05/14/2015SE |
| K121418 | Planmed VerityJAK · Traditional | 02/01/2013SE |
| K121963 | Planmed Nuance DigiguideMUE · Traditional | 11/21/2012SE |
| K042671 | Planmed Sophie Nuance ClassicIZH · Traditional | 11/19/2004SE |
| K021945 | Planmed Sophie & Sophie Classic (with Digispot and Cytoguide)IZH · Traditional | 02/21/2003SE |
Questions and answers
When was Planmed Clarity 2D, Planmed Clarify S cleared by the FDA?
Planmed Clarity 2D, Planmed Clarify S (K211720) received a 510(k) decision of Substantially Equivalent on July 18, 2022, 409 days after the submission was received.
What is the product code of K211720?
The FDA product code is MUE – Full Field Digital, System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1715.