Arterys MICA
FDA 510(k) K192437 · Arterys, Inc.
510(k) numberK192437
Submission
- Device name
- Arterys MICA
- Applicant
- Arterys, Inc.
San Francisco, CA, US - Received
- September 6, 2019
- Decision date
- March 25, 2020
- 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 |
|---|---|---|
| K252539 | Tempus PixelQIH · Special | 09/03/2025SE |
| K203744 | Arterys MICAQIH · Traditional | 03/14/2022SE |
| K182034 | Arterys MICALLZ · Traditional | 10/17/2018SE |
| K173542 | Arterys Oncology DLLLZ · Traditional | 01/25/2018SE |
| K171544 | Arterys ViewerLLZ · Traditional | 07/18/2017SE |
| K163253 | Arterys Cardio DLLLZ · Traditional | 01/05/2017SE |
| K162513 | Arterys Software v2.0LLZ · Traditional | 10/28/2016SE |
Questions and answers
When was Arterys MICA cleared by the FDA?
Arterys MICA (K192437) received a 510(k) decision of Substantially Equivalent on March 25, 2020, 201 days after the submission was received.
What is the product code of K192437?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.