FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Saige-Dx
K Number: K241747
·
Decision Nov 18, 2024
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
34
Applicant Total
10
Review Days
153
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Basic Information
- Device Name
- Saige-Dx
- K Number
- K241747
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2090
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DeepHealth, Inc.
- Date Received
- June 18, 2024
- Decision Date
- November 18, 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
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Other Clearances by DeepHealth, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253825 | Saige-Dx | Jun 15, 2026 | Substantially Equivalent |
| K254131 | BAC | May 21, 2026 | Substantially Equivalent |
| K251873 | Saige-Dx | Aug 11, 2025 | Substantially Equivalent |
| K243703 | TechLive | Jun 5, 2025 | Substantially Equivalent |
| K243688 | Saige-Dx (3.1.0) | Dec 19, 2024 | Substantially Equivalent |
| K243705 | Saige-Density (2.5.0) | Dec 19, 2024 | Substantially Equivalent |
| K222275 | Saige-Density | Dec 16, 2022 | Substantially Equivalent |
| K220105 | Saige-Dx | May 12, 2022 | Substantially Equivalent |
| K203517 | Saige-Q | Apr 16, 2021 | Substantially Equivalent |