Clever One
FDA 510(k) K250005 · Ewoosoft Co., Ltd.
510(k) numberK250005
Submission
- Device name
- Clever One
- Applicant
- Ewoosoft Co., Ltd.
Hwaseong-Si, KR - Received
- January 2, 2025
- Decision date
- May 23, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QIH – Automated Radiological Image Processing Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
Other 510(k)s with product code QIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261795 | Quicktome Software SuiteQIH · Traditional | Omniscient Neurotechnology Pty, Ltd. | 09/10/2026SE |
| K260879 | 4DMQIH · Traditional | Invia, LLC | 09/10/2026SE |
| K251417 | ReVISION 2QIH · Traditional | Argus Cognitive, Inc. | 09/09/2026SE |
| K260525 | NextMR SpineQIH · Traditional | MRI2CT, Inc. | 09/04/2026SE |
| K260811 | Heartvue.ProtonQIH · Traditional | Heartvue.ai, Inc. | 08/26/2026SE |
| K261595 | Ceevra Reveal 4QIH · Traditional | Ceevra, Inc. | 08/25/2026SE |
| K262127 | DS Core CBCT AnatomyQIH · Traditional | Dentsply Sirona | 08/21/2026SE |
| K260584 | BoneMRIQIH · Traditional | Mriguidance B.V. | 08/21/2026SE |
| K261641 | Lower Limb AI (LLAI)QIH · Traditional | AI Planning Logic, Inc. | 08/18/2026SE |
| K253794 | Prostate CoreQIH · Traditional | Lucida Medical, Ltd. | 08/10/2026SE |
More from Lucida Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)LLZ · Special | 07/23/2024SE |
| K231757 | Ez3D-i /E3QIH · Special | 07/14/2023SE |
| K230468 | EzDent WebLLZ · Traditional | 04/21/2023SE |
| K223820 | EzDent-i / E2 / Prora View/ Smart M ViewerLLZ · Traditional | 02/17/2023SE |
| K222069 | Ez3D-i/E3LLZ · Traditional | 09/06/2022SE |
| K222145 | EzDent-i / E2 / Prora View/ Smart M ViewerLLZ · Traditional | 08/12/2022SE |
| K220003 | EzOrtho v1.3LLZ · Traditional | 02/23/2022SE |
| K211795 | EzDent-i/ E2/ Prora View/ Smart M ViewerLLZ · Traditional | 10/04/2021SE |
| K211700 | EzDent WebLLZ · Traditional | 09/28/2021SE |
| K211793 | EzOrthoLLZ · Traditional | 08/23/2021SE |
Questions and answers
When was Clever One cleared by the FDA?
Clever One (K250005) received a 510(k) decision of Substantially Equivalent on May 23, 2025, 141 days after the submission was received.
What is the product code of K250005?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.