Lunit INSIGHT DBT v1.1
FDA 510(k) K242652 · Lunit, Inc.
Submission
- Device name
- Lunit INSIGHT DBT v1.1
- Applicant
- Lunit, Inc.
Seoul, KR - Received
- September 4, 2024
- Decision date
- October 4, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QDQ – Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2090
- Specialty
- Radiology
A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on…
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| K260320 | Lunit INSIGHT MMG (v1.1.10)QDQ · Special | Lunit, Inc. | 04/23/2026SE |
| K253796 | Lunit INSIGHT DBT (V1.2)QDQ · Traditional | Lunit, Inc. | 03/26/2026SE |
| K251474 | Median LCS (internal name) / eyonis LCS (trade name) (1.0)QDQ · Traditional | Median Technologies | 02/06/2026SE |
| K251873 | Saige-DxQDQ · Special | DeepHealth, Inc. | 08/11/2025SE |
More from DeepHealth, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260320 | Lunit INSIGHT MMG (v1.1.10)QDQ · Special | 04/23/2026SE |
| K253796 | Lunit INSIGHT DBT (V1.2)QDQ · Traditional | 03/26/2026SE |
| K231470 | Lunit INSIGHT DBTQDQ · Traditional | 11/06/2023SE |
| K211678 | Lunit INSIGHT MMGQDQ · Traditional | 11/17/2021SE |
| K211733 | Lunit INSIGHT CXR TriageQFM · Traditional | 11/10/2021SE |
Questions and answers
When was Lunit INSIGHT DBT v1.1 cleared by the FDA?
Lunit INSIGHT DBT v1.1 (K242652) received a 510(k) decision of Substantially Equivalent on October 4, 2024, 30 days after the submission was received.
What is the product code of K242652?
The FDA product code is QDQ – Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, a Class II (moderate risk) device regulated under 21 CFR 892.2090.