IRISeg
FDA 510(k) K251763 · Intuitive Surgical, Inc.
510(k) numberK251763
Submission
- Device name
- IRISeg
- Applicant
- Intuitive Surgical, Inc.
Sunnyvale, CA, US - Received
- June 9, 2025
- Decision date
- December 16, 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 |
|---|---|---|
| K261823 | da Vinci Surgical System, Model IS5000NAY · Traditional | 09/08/2026SE |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000)FDS · Traditional | 08/07/2026SE |
| K261824 | da Vinci Surgical System, Model IS5000NAY · Traditional | 07/31/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | 07/14/2026SE |
| K260695 | da Vinci Firefly Imaging SystemNAY · Traditional | 05/22/2026SE |
| K253986 | da Vinci Force Feedback InstrumentsNAY · Traditional | 03/11/2026SE |
| K253978 | Universal Seal (5-12 mm)GCJ · Traditional | 02/24/2026SE |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorNAY · Traditional | 01/16/2026SE |
| K251739 | da Vinci Surgical System (IS5000)NAY · Traditional | 01/16/2026SE |
| K252675 | da Vinci SP Surgical System (SP1098)NAY · Traditional | 12/15/2025SE |
Questions and answers
When was IRISeg cleared by the FDA?
IRISeg (K251763) received a 510(k) decision of Substantially Equivalent on December 16, 2025, 190 days after the submission was received.
What is the product code of K251763?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.