Ultrasound Workspace (UWS 6.0)
FDA 510(k) K241659 · Philips Ultrasound, LLC
510(k) numberK241659
Submission
- Device name
- Ultrasound Workspace (UWS 6.0)
- Applicant
- Philips Ultrasound, LLC
Bothell, WA, US - Received
- June 10, 2024
- Decision date
- February 10, 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.
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| 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 |
|---|---|---|
| K262311 | Alturion Series Diagnostic Ultrasound SystemIYN · Special | 08/04/2026SE |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional | 07/27/2026SE |
| K260667 | Alturion Series Diagnostic Ultrasound SystemIYN · Traditional | 06/29/2026SE |
| K260680 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN · Special | 05/27/2026SE |
| K260123 | EPIQ Series Diagnostic Ultrasound SystemIYN · Traditional | 05/27/2026SE |
| K252558 | Lumify Diagnostic Ultrasound SystemIYN · Traditional | 05/05/2026SE |
| K253595 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN · Traditional | 03/27/2026SE |
| K252557 | Lumify Diagnostic Ultrasound SystemIYN · Traditional | 12/22/2025SE |
| K251651 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN · Special | 10/09/2025SE |
| K251455 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN · Special | 07/24/2025SE |
Questions and answers
When was Ultrasound Workspace (UWS 6.0) cleared by the FDA?
Ultrasound Workspace (UWS 6.0) (K241659) received a 510(k) decision of Substantially Equivalent on February 10, 2025, 245 days after the submission was received.
What is the product code of K241659?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.