deepLive
FDA 510(k) K240610 · Damae Medical
510(k) numberK240610
Submission
- Device name
- deepLive
- Applicant
- Damae Medical
Paris, FR - Received
- March 5, 2024
- Decision date
- July 9, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQQ – System, Imaging, Optical Coherence Tomography (Oct)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1560
- Specialty
- Radiology
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
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|---|---|---|---|
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| K253101 | HyperVue Imaging System - IntegratedNQQ · Traditional | Spectrawave, Inc. | 12/15/2025SE |
| K252851 | deepLive (OSP12 + DMS)NQQ · Special | Damae Medical | 10/07/2025SE |
| K251198 | HyperVue SoftwareNQQ · Traditional | Spectrawave, Inc. | 07/16/2025SE |
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| K243016 | Starlight Imaging CatheterNQQ · Special | Spectrawave, Inc. | 03/20/2025SE |
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More from Gentuity, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K252851 | deepLive (OSP12 + DMS)NQQ · Special | 10/07/2025SE |
Questions and answers
When was deepLive cleared by the FDA?
deepLive (K240610) received a 510(k) decision of Substantially Equivalent on July 9, 2024, 126 days after the submission was received.
What is the product code of K240610?
The FDA product code is NQQ – System, Imaging, Optical Coherence Tomography (Oct), a Class II (moderate risk) device regulated under 21 CFR 892.1560.