FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
MX30N(MX30TQS)
K Number: K160346
·
Decision Apr 14, 2016
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
134
Applicant Total
20
Review Days
66
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Basic Information
- Device Name
- MX30N(MX30TQS)
- K Number
- K160346
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wide Corporation
- Date Received
- February 8, 2016
- Decision Date
- April 14, 2016
- Product Code
- PGY
- 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 |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | FDA class 2 | Radiology |
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Other Clearances by Wide Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K222719 | CX50N | May 9, 2023 | Substantially Equivalent |
| K222716 | MX50N | May 8, 2023 | Substantially Equivalent |
| K222722 | CW60N | Oct 31, 2022 | Substantially Equivalent |
| K222717 | CL24N | Oct 31, 2022 | Substantially Equivalent |
| K210493 | CX30N (CX30PQX) | Apr 14, 2021 | Substantially Equivalent |
| K210491 | CW120N | Apr 8, 2021 | Substantially Equivalent |
| K170781 | MX50N(MX50YQS) | Apr 4, 2017 | Substantially Equivalent |
| K170783 | CX50N(CX50YQS) | Mar 31, 2017 | Substantially Equivalent |
| K160354 | MX50T(MX50TQS) | May 2, 2016 | Substantially Equivalent |
| K160353 | MX50N(MX50YQS) | Apr 22, 2016 | Substantially Equivalent |