FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Caption Guidance
K Number: K200755
·
Decision Apr 16, 2020
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
7
Applicant Total
4
Review Days
24
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Basic Information
- Device Name
- Caption Guidance
- K Number
- K200755
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Caption Health
- Date Received
- March 23, 2020
- Decision Date
- April 16, 2020
- Product Code
- QJU
- 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 |
|---|---|---|---|
| QJU | Image Acquisition And/Or Optimization Guided By Artificial Intelligence | FDA class 2 | Radiology |
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