FDR Visionary Suite
FDA 510(k) K233719 · Shimadzu Corporation
510(k) numberK233719
Submission
- Device name
- FDR Visionary Suite
- Applicant
- Shimadzu Corporation
Kyoto, JP - Received
- November 21, 2023
- Decision date
- March 28, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KPR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…KPR · Traditional | DRTECH Corporation | 09/08/2026SE |
| K260488 | MULTIX Impact; MULTIX Impact CKPR · Traditional | Siemens Medical Solutions USA, Inc. | 08/31/2026SE |
| 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 |
|---|---|---|
| K252099 | TriniasOWB · Abbreviated | 03/24/2026SE |
| K233722 | RADspeed ProKPR · Traditional | 02/23/2024SE |
| K191877 | FLUOROspeedJAA · Special | 08/05/2019SE |
| K190373 | SonialVision G4JAA · Special | 03/15/2019SE |
| K173517 | RADspeed fitKPR · Traditional | 03/30/2018SE |
| K152294 | FDR Visionary SuiteKPR · Traditional | 07/15/2016SE |
| K152244 | RADspeed ProKPR · Traditional | 06/20/2016SE |
| K142341 | X-Ray TV System Sonialvision G4JAA · Abbreviated | 03/06/2015SE |
| K131075 | X-Ray TV System Sonial Vision G4JAA · Abbreviated | 03/28/2014SE |
| K123508 | TriniasOWB · Abbreviated | 02/26/2014SE |
Questions and answers
When was FDR Visionary Suite cleared by the FDA?
FDR Visionary Suite (K233719) received a 510(k) decision of Substantially Equivalent on March 28, 2024, 128 days after the submission was received.
What is the product code of K233719?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.