Expd 4343S
FDA 510(k) K232082 · DRTECH Corporation
510(k) numberK232082
Submission
- Device name
- Expd 4343S
- Applicant
- DRTECH Corporation
Gyeonggi-Do, KR - Received
- July 13, 2023
- Decision date
- February 13, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…KPR · Traditional | 09/08/2026SE |
| K261413 | Extron 3;EXTRON 6OWB · Traditional | 08/19/2026SE |
| K250010 | Extron 3; Extron 5; Extron 7OWB · Traditional | 06/10/2025SE |
| K242770 | Expd 114; Expd 114G; Expd 114P; Expd 114PGMQB · Special | 03/20/2025SE |
| K243443 | Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…MQB · Special | 03/19/2025SE |
| K242591 | XERO-alphaEHD · Traditional | 11/01/2024SE |
| K242847 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…KPR · Special | 10/23/2024SE |
| K240243 | EConsole2LLZ · Traditional | 09/23/2024SE |
| K233530 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…KPR · Traditional | 07/26/2024SE |
| K232753 | Expd 4343D; Expd 3643DMQB · Special | 11/16/2023SE |
Questions and answers
When was Expd 4343S cleared by the FDA?
Expd 4343S (K232082) received a 510(k) decision of Substantially Equivalent on February 13, 2024, 215 days after the submission was received.
What is the product code of K232082?
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.