FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
K Number: K240697
·
Decision Sep 9, 2024
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
34
Applicant Total
2
Review Days
179
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
- See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
- K Number
- K240697
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2090
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- See-Mode Technologies Pte, Ltd.
- Date Received
- March 14, 2024
- Decision Date
- September 9, 2024
- Product Code
- QDQ
- 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 |
|---|---|---|---|
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QDQ), ordered by most recent decision date.
Saige-Dx
FDA 510(k)
FDA Class 2
·Radiology
DeepHealth ProstateAI
FDA 510(k)
FDA Class 2
·Radiology
Lunit INSIGHT MMG (v1.1.10)
FDA 510(k)
FDA Class 2
·Radiology
Lunit INSIGHT DBT (V1.2)
FDA 510(k)
FDA Class 2
·Radiology
Median LCS (internal name) / eyonis LCS (trade name) (1.0)
FDA 510(k)
FDA Class 2
·Radiology
Saige-Dx
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by See-Mode Technologies Pte, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K201369 | AVA (Augmented Vascular Analysis) | Sep 16, 2020 | Substantially Equivalent |