Extron 5; Extron 7
FDA 510(k) K230871 · DRTECH Corporation
510(k) numberK230871
Submission
- Device name
- Extron 5; Extron 7
- Applicant
- DRTECH Corporation
Seongnam-Si, KR - Received
- March 30, 2023
- Decision date
- August 17, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code OWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253726 | uAngio AVIVA CXOWB · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 08/21/2026SE |
| K261413 | Extron 3;EXTRON 6OWB · Traditional | DRTECH Corporation | 08/19/2026SE |
| K254205 | Zenition 30OWB · Traditional | Philips Medical Systems Nederland B.V. | 08/07/2026SE |
| K260607 | Shield System (Siemens 30x40)OWB · Special | Radiaction , Ltd. | 07/31/2026SE |
| K253670 | SmartCT (R3.0 (L10))OWB · Abbreviated | Philips Medical Systems B.V. | 07/10/2026SE |
| K252735 | C-beamOWB · Traditional | Pulmera, Inc. | 05/22/2026SE |
| K252503 | Intelligent NROWB · Traditional | Canon, Inc. | 04/30/2026SE |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional | Siemens Medical Solutions USA, Inc. | 04/24/2026SE |
| K253752 | ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional | Siemens Medical Solutions USA, Inc. | 04/23/2026SE |
| K252229 | Belliger AceOWB · Traditional | Genoray Co., Ltd. | 04/02/2026SE |
More from Genoray Co., Ltd.
| 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 |
| K232082 | Expd 4343SMQB · Special | 02/13/2024SE |
Questions and answers
When was Extron 5; Extron 7 cleared by the FDA?
Extron 5; Extron 7 (K230871) received a 510(k) decision of Substantially Equivalent on August 17, 2023, 140 days after the submission was received.
What is the product code of K230871?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.