FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Cruxcan (CRX-1000)
K Number: K183637
·
Decision Feb 12, 2019
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
2
Review Days
48
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Basic Information
- Device Name
- Cruxcan (CRX-1000)
- K Number
- K183637
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cruxell Corp.
- Date Received
- December 26, 2018
- Decision Date
- February 12, 2019
- Product Code
- MUH
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
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Other Clearances by Cruxell Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K211317 | CRUXVIEW | Jul 29, 2021 | Substantially Equivalent |