FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Auto Lung Nodule Detection
K Number: K201560
·
Decision Aug 31, 2021
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
36
Applicant Total
40
Review Days
447
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Basic Information
- Device Name
- Auto Lung Nodule Detection
- K Number
- K201560
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2070
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Samsung Electronics Co., Ltd.
- Date Received
- June 10, 2020
- Decision Date
- August 31, 2021
- Product Code
- MYN
- 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 |
|---|---|---|---|
| MYN | Analyzer, Medical Image | FDA class 2 | Radiology |
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