Syngo Carbon Clinicals (VA41)
FDA 510(k) K251059 · Siemens Healthineers AG
510(k) numberK251059
Submission
- Device name
- Syngo Carbon Clinicals (VA41)
- Applicant
- Siemens Healthineers AG
Forchheim, DE - Received
- April 4, 2025
- Decision date
- October 24, 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 |
|---|---|---|
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureLNH · Traditional | 07/31/2026SE |
| K253690 | LungMapsQIH · Traditional | 06/15/2026SE |
| K253023 | BIOGRAPH OneOUO · Traditional | 01/15/2026SE |
| K253495 | syngo.MR Applications (VB80)LLZ · Traditional | 11/20/2025SE |
| K241898 | Symbia SPECT and SPECT/CT SystemsKPS · Special | 07/26/2024SE |
| K183575 | ACUSON S3000, S2000 Diagnostic Ultrasound SystemIYN · Traditional | 03/20/2019SE |
Questions and answers
When was Syngo Carbon Clinicals (VA41) cleared by the FDA?
Syngo Carbon Clinicals (VA41) (K251059) received a 510(k) decision of Substantially Equivalent on October 24, 2025, 203 days after the submission was received.
What is the product code of K251059?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.