FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
iBreastExam
K Number: K190575
·
Decision Jul 16, 2019
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
3
Review Days
132
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Basic Information
- Device Name
- iBreastExam
- K Number
- K190575
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 884.2990
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ue Lifesciences, Inc.
- Date Received
- March 6, 2019
- Decision Date
- July 16, 2019
- Product Code
- NKA
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| NKA | System, Documentation, Breast Lesion | FDA class 2 | Obstetrics/Gynecology |
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