FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Focus HD 35 Detector
K Number: K213646
·
Decision Mar 29, 2022
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
21
Review Days
145
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Basic Information
- Device Name
- Focus HD 35 Detector
- K Number
- K213646
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iray Technology Taicang , Ltd.
- Date Received
- November 4, 2021
- Decision Date
- March 29, 2022
- Product Code
- MQB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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Other Clearances by Iray Technology Taicang , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K223010 | Portable X-ray System | Jan 17, 2023 | Substantially Equivalent |
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| K221714 | Flat Panel Detector | Jun 29, 2022 | Substantially Equivalent |
| K221345 | Wireless Digital Flat Panel Detector | Jun 16, 2022 | Substantially Equivalent |
| K220536 | Digital flat panel detector | Apr 28, 2022 | Substantially Equivalent |
| K220668 | Wireless Digital Flat Panel Detector | Apr 1, 2022 | Substantially Equivalent |
| K213529 | Focus HD 43 Detector | Mar 29, 2022 | Substantially Equivalent |
| K220422 | Dental sensors NanoPix1, NanoPix2 | Mar 11, 2022 | Substantially Equivalent |
| K212279 | Digital Intraoral X-ray Imaging System | Oct 7, 2021 | Substantially Equivalent |
| K210312 | PlutoX Digital Intraoral X-Ray Imaging System | Apr 23, 2021 | Substantially Equivalent |