FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
SKR 3000
K Number: K250665
·
Decision Jun 17, 2025
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
25
Review Days
104
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Basic Information
- Device Name
- SKR 3000
- K Number
- K250665
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Konica Minolta, Inc.
- Date Received
- March 5, 2025
- Decision Date
- June 17, 2025
- 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 Konica Minolta, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K241319 | SKR 3000 | Nov 21, 2024 | Substantially Equivalent |
| K240281 | Bone Suppression Software | May 31, 2024 | Substantially Equivalent |
| K230906 | Konicaminolta DI-X1 | Apr 25, 2023 | Substantially Equivalent |
| K223267 | SKR 3000 | Nov 17, 2022 | Substantially Equivalent |
| K220993 | Ultrasound System SONIMAGE MX1 | Jun 23, 2022 | Substantially Equivalent |
| K213908 | SKR 3000 | Jan 31, 2022 | Substantially Equivalent |
| K212685 | KONICAMINOLTA DI-X1 | Sep 13, 2021 | Substantially Equivalent |
| K210619 | SKR 3000 | Aug 24, 2021 | Substantially Equivalent |
| K210066 | ImagePilot | May 6, 2021 | Substantially Equivalent |
| K191645 | SKR 4000 | Aug 16, 2019 | Substantially Equivalent |