SKR 3000
FDA 510(k) K210619 · Konica Minolta, Inc.
510(k) numberK210619
Submission
- Device name
- SKR 3000
- Applicant
- Konica Minolta, Inc.
Hino-Shi, JP - Received
- March 1, 2021
- Decision date
- August 24, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MQB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253800 | 0909FCE, 0909FCE-HSMQB · Traditional | Rayence Co., Ltd. | 07/31/2026SE |
| K260820 | Vivix-S 4386W (FXRD-4386WA)MQB · Special | Vieworks Co., Ltd. | 06/18/2026SE |
| K252996 | Universal 1417PIMQB · Abbreviated | Konica Minolta Healthcare Americas, Inc. | 06/12/2026SE |
| K252911 | Lux HD 2530 detector (Lux HD 2530)MQB · Special | Iray Imaging Technology (Haining) Limited | 10/09/2025SE |
| K250211 | Yushan X-Ray Flat Panel DetectorMQB · Traditional | Innocare Optoelectronics Corp. | 07/22/2025SE |
| K250665 | SKR 3000MQB · Traditional | Konica Minolta, Inc. | 06/17/2025SE |
| K243734 | Wireless/ Wired X-Ray Flat Panel DetectorsMQB · Special | Allengers Medical Systems Limited | 04/18/2025SE |
| K242770 | Expd 114; Expd 114G; Expd 114P; Expd 114PGMQB · Special | DRTECH Corporation | 03/20/2025SE |
| K243443 | Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…MQB · Special | DRTECH Corporation | 03/19/2025SE |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)MQB · Traditional | Iray Imaging Technology (Haining) Limited | 03/18/2025SE |
More from Iray Imaging Technology (Haining) Limited
| 510(k) | Device | Decision |
|---|---|---|
| K250665 | SKR 3000MQB · Traditional | 06/17/2025SE |
| K241319 | SKR 3000MQB · Traditional | 11/21/2024SE |
| K240281 | Bone Suppression SoftwareLLZ · Traditional | 05/31/2024SE |
| K230906 | Konicaminolta DI-X1LLZ · Special | 04/25/2023SE |
| K223267 | SKR 3000MQB · Special | 11/17/2022SE |
| K220993 | Ultrasound System SONIMAGE MX1IYN · Traditional | 06/23/2022SE |
| K213908 | SKR 3000MQB · Traditional | 01/31/2022SE |
| K212685 | Konicaminolta DI-X1LLZ · Special | 09/13/2021SE |
| K210066 | ImagePilotLLZ · Special | 05/06/2021SE |
| K191645 | SKR 4000MQB · Traditional | 08/16/2019SE |
Questions and answers
When was SKR 3000 cleared by the FDA?
SKR 3000 (K210619) received a 510(k) decision of Substantially Equivalent on August 24, 2021, 176 days after the submission was received.
What is the product code of K210619?
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.