510(k) K243688
- Device
- Saige-Dx (3.1.0)
- Applicant
- DeepHealth, Inc.
- 510(k) number
- K243688
- Product code
- QDQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-19
- Date received
- 2024-11-29
- Regulation
- 892.2090
- Classification name
- Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- B. Nathan Hunt
- Address
- 212 Elm St. Somerville MA US 02144 02144
FDA Registration Numbers
- 3016819165
- 3026970882
- 3021230777
- 3025343020
- 3015173173
- 3030412475
- 3023522713
- 3018733944
- 3016759115
- 3005496266
- 3042248552
Source Documents
Other 510(k) Records For Product Code QDQ
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|---|---|---|---|
| K253682 | DeepHealth ProstateAI | Quantib B.V. | 2026-04-29 |
| K260320 | Lunit INSIGHT MMG (v1.1.10) | Lunit, Inc. | 2026-04-23 |
| K253796 | Lunit INSIGHT DBT (V1.2) | Lunit, Inc. | 2026-03-26 |
| K251474 | Median LCS (internal name) / eyonis LCS (trade name) (1.0) | Median Technologies | 2026-02-06 |
| K251873 | Saige-Dx | DeepHealth, Inc. | 2025-08-11 |
| K243341 | Genius AI Detection 2.0 | Hologic, Inc. | 2025-07-31 |
| K243679 | MammoScreen® (4) | Therapixel | 2025-07-03 |
| K242683 | QP-Prostate® CAD | Quibim S.L. | 2025-03-18 |
| K241770 | Prostate MR AI (VA10A) | Siemens Healthcare GmbH | 2025-03-05 |
| K241831 | Transpara (2.1.0) | Screenpoint Medical B.V. | 2024-11-25 |
| K241747 | Saige-Dx | DeepHealth, Inc. | 2024-11-18 |
| K240417 | ProFound Detection (V4.0) | Icad, Inc. | 2024-11-08 |
| K242652 | Lunit INSIGHT DBT v1.1 | Lunit, Inc. | 2024-10-04 |
| K240697 | See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | See-Mode Technologies Pte, Ltd. | 2024-09-09 |
| K240301 | MammoScreen® (3) | Therapixel | 2024-08-01 |