UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
FDA 510(k) K250328 · Canon Medical Systems Corporation
Submission
- Device name
- UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
- Applicant
- Canon Medical Systems Corporation
Otawara-Shi, JP - Received
- February 5, 2025
- Decision date
- April 30, 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | 05/20/2026SE |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…LNH · Traditional | 03/27/2026SE |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0JAK · Traditional | 03/13/2026SE |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)OWB · Traditional | 03/10/2026SE |
| K253597 | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemIYN · Traditional | 01/20/2026SE |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21KPS · Traditional | 12/01/2025SE |
| K252074 | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemIYN · Traditional | 10/31/2025SE |
| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingOWB · Traditional | 10/10/2025SE |
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…JAK · Traditional | 09/26/2025SE |
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…LNH · Traditional | 07/22/2025SE |
Questions and answers
When was UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program cleared by the FDA?
UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program (K250328) received a 510(k) decision of Substantially Equivalent on April 30, 2025, 84 days after the submission was received.
What is the product code of K250328?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.