FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
EVS 3643
K Number: K151942
·
Decision Oct 21, 2015
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
25
Review Days
99
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Basic Information
- Device Name
- EVS 3643
- K Number
- K151942
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DRTECH Corporation
- Date Received
- July 14, 2015
- Decision Date
- October 21, 2015
- 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 |
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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 |
| K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP | Mar 19, 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 |