EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP
FDA 510(k) clearance K243443 · decided 2025-03-19
Clearance details
- K-number
- K243443
- Device name
- EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP
- Applicant
- DRTECH Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-11-06
- Decision date
- 2025-03-19
- Days to decision
- 133 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Gyeonggi-Do, KR
- Third-party review
- No
- Expedited review
- No
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| Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) (K243556) | Iray Imaging Technology (Haining) Limited | 2025-03-18 |
| ExamVue Apex (K244010) | Jpi Healthcare Co, Ltd. | 2025-02-24 |
| Yushan X-Ray Flat Panel Detector (K243171) | Innocare Optoelectronics Corp. | 2024-12-19 |
| SKR 3000 (K241319) | Konica Minolta, Inc. | 2024-11-21 |
Recalls involving this device
No recalls on record reference this clearance.