FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Sentinel BreastScan II System
K Number: K162767
·
Decision Jan 9, 2017
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
40
Applicant Total
2
Review Days
101
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Sentinel BreastScan II System
- K Number
- K162767
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 884.2980
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- First Sense Medical, LLC
- Date Received
- September 30, 2016
- Decision Date
- January 9, 2017
- Product Code
- LHQ
- Advisory Committee
- Obstetrics/Gynecology
- 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 |
|---|---|---|---|
| LHQ | System, Telethermographic (Adjunctive Use) | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LHQ), ordered by most recent decision date.
Derma-2
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ThermPix Thermovisual Camera
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ThermPix Thermovisual Camera
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Smile-100 System
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
IRIS-XP
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Thermidas IR System (ThIR-A615)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Other Clearances by First Sense Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K160573 | FirstSense Breast Exam | Jun 1, 2016 | Substantially Equivalent |