FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT
K Number: K140342
·
Decision Aug 29, 2014
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
146
Applicant Total
3
Review Days
199
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Basic Information
- Device Name
- QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT
- K Number
- K140342
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1170
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mindways Software, Inc.
- Date Received
- February 11, 2014
- Decision Date
- August 29, 2014
- Product Code
- KGI
- 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 |
|---|---|---|---|
| KGI | Densitometer, Bone | FDA class 2 | Radiology |
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