Focus 35C Detector, Trimax 35C Detector
FDA 510(k) K192512 · Iray Technology Taicang , Ltd.
510(k) numberK192512
Submission
- Device name
- Focus 35C Detector, Trimax 35C Detector
- Applicant
- Iray Technology Taicang , Ltd.
Taicang, CN - Received
- September 12, 2019
- Decision date
- October 16, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K220536 | Digital flat panel detectorMQB · Traditional | 04/28/2022SE |
| K220668 | Wireless Digital Flat Panel DetectorMQB · Special | 04/01/2022SE |
| K213646 | Focus HD 35 DetectorMQB · Special | 03/29/2022SE |
| K213529 | Focus HD 43 DetectorMQB · Special | 03/29/2022SE |
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Questions and answers
When was Focus 35C Detector, Trimax 35C Detector cleared by the FDA?
Focus 35C Detector, Trimax 35C Detector (K192512) received a 510(k) decision of Substantially Equivalent on October 16, 2019, 34 days after the submission was received.
What is the product code of K192512?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.