FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Koios DS for Breast
K Number: K190442
·
Decision Jul 3, 2019
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
21
Applicant Total
3
Review Days
128
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Basic Information
- Device Name
- Koios DS for Breast
- K Number
- K190442
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2060
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Koios Medical, Inc.
- Date Received
- February 25, 2019
- Decision Date
- July 3, 2019
- Product Code
- POK
- 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 |
|---|---|---|---|
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | FDA class 2 | Radiology |
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