FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP
K Number: K243443
·
Decision Mar 19, 2025
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
25
Review Days
133
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP
- K Number
- K243443
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DRTECH Corporation
- Date Received
- November 6, 2024
- Decision Date
- March 19, 2025
- Product Code
- MQB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQB), ordered by most recent decision date.
VIVIX-S 4386W (FXRD-4386WA)
FDA 510(k)
FDA Class 2
·Radiology
Universal 1417PI
FDA 510(k)
FDA Class 2
·Radiology
Lux HD 2530 detector (Lux HD 2530)
FDA 510(k)
FDA Class 2
·Radiology
Yushan X-Ray Flat Panel Detector
FDA 510(k)
FDA Class 2
·Radiology
SKR 3000
FDA 510(k)
FDA Class 2
·Radiology
Wireless/ Wired X-Ray Flat Panel Detectors
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by DRTECH Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K250010 | EXTRON 3; EXTRON 5; EXTRON 7 | Jun 10, 2025 | Substantially Equivalent |
| K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | Mar 20, 2025 | Substantially Equivalent |
| K242591 | XERO-alpha | Nov 1, 2024 | Substantially Equivalent |
| K242847 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); | Oct 23, 2024 | Substantially Equivalent |
| K240243 | EConsole2 | Sep 23, 2024 | Substantially Equivalent |
| K233530 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM) | Jul 26, 2024 | Substantially Equivalent |
| K232082 | EXPD 4343S | Feb 13, 2024 | Substantially Equivalent |
| K232753 | EXPD 4343D; EXPD 3643D | Nov 16, 2023 | Substantially Equivalent |
| K231225 | EConsole1 | Oct 18, 2023 | Substantially Equivalent |
| K230871 | EXTRON 5; EXTRON 7 | Aug 17, 2023 | Substantially Equivalent |