SubtleHD-CT (1.x)
FDA 510(k) K254120 · Subtle Medical, Inc.
510(k) numberK254120
Submission
- Device name
- SubtleHD-CT (1.x)
- Applicant
- Subtle Medical, Inc.
Menlo Park, CA, US - Received
- December 19, 2025
- Decision date
- May 15, 2026
- 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 |
|---|---|---|
| K254013 | SubtleHD-PET (1.x)LLZ · Traditional | 05/14/2026SE |
| K243250 | SubtleHD (1.x)QIH · Traditional | 02/12/2025SE |
| K240290 | AiMIFY (1.x)LLZ · Traditional | 08/21/2024SE |
| K241329 | SubtleSYNTH (1.x)QIH · Traditional | 07/11/2024SE |
| K233699 | SubtleREFORMAT (1.x)LLZ · Traditional | 04/29/2024SE |
| K223623 | SubtleMR (2.3.x)LLZ · Traditional | 05/11/2023SE |
| K211964 | SubtlePETKPS · Traditional | 09/28/2021SE |
| K203182 | SubtleMRLLZ · Traditional | 02/26/2021SE |
| K191688 | SubtleMRLLZ · Traditional | 09/16/2019SE |
| K182336 | SubtlePETKPS · Traditional | 11/30/2018SE |
Questions and answers
When was SubtleHD-CT (1.x) cleared by the FDA?
SubtleHD-CT (1.x) (K254120) received a 510(k) decision of Substantially Equivalent on May 15, 2026, 147 days after the submission was received.
What is the product code of K254120?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.