Aerodr System
FDA 510(k) K102349 · Konica Minolta Medical & Graphic, Inc.
510(k) numberK102349
Submission
- Device name
- Aerodr System
- Applicant
- Konica Minolta Medical & Graphic, Inc.
New York, NY, US - Received
- August 19, 2010
- Decision date
- November 24, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260481 | GC85AKPR · Traditional | Samsung Electronics Co., Ltd. | 08/27/2026SE |
| K260482 | DRE DuoKPR · Traditional | Jpi Healthcare Co, Ltd. | 06/15/2026SE |
| K253446 | AeroDR TX c02KPR · Traditional | Dk Medical Systems Co., Ltd. | 04/10/2026SE |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…KPR · Traditional | Carestream Health | 01/20/2026SE |
| K252000 | uDR Arria & uDR ArisKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 11/26/2025SE |
| K251167 | uDR Aurora CXKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 09/19/2025SE |
| K250788 | Definium Tempo SelectKPR · Traditional | Ge Hualun Medical Systems Co. , Ltd. | 08/28/2025SE |
| K250790 | Innovision-DxiiKPR · Traditional | Dk Medical Systems Co., Ltd. | 08/01/2025SE |
More from Dk Medical Systems Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K130936 | Aerodr System with P-31MQB · Traditional | 08/22/2013SE |
| K123499 | AeropilotMQB · Traditional | 12/20/2012SE |
| K120752 | Aerodr Stitching SystemKPR · Traditional | 06/08/2012SE |
| K121109 | Aerodr X70KPR · Traditional | 05/23/2012SE |
| K120477 | Aerosync for Aerodr SystemMQB · Traditional | 04/09/2012SE |
| K120131 | Regius SIGMA2MQB · Special | 02/10/2012SE |
| K113248 | Aerodr System with P-21KPR · Special | 01/17/2012SE |
| K110717 | Konica Minolta Xpress Digital Mammography SystemMUE · Traditional | 12/23/2011SE |
| K103703 | Reguis SigmaMQB · Traditional | 06/02/2011SE |
| K101842 | AciesLLZ · Traditional | 02/04/2011SE |
Questions and answers
When was Aerodr System cleared by the FDA?
Aerodr System (K102349) received a 510(k) decision of Substantially Equivalent on November 24, 2010, 97 days after the submission was received.
What is the product code of K102349?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.