BriefCase-Quantification
FDA 510(k) K242203 · Aidoc Medical , Ltd.
510(k) numberK242203
Submission
- Device name
- BriefCase-Quantification
- Applicant
- Aidoc Medical , Ltd.
Tell-Aviv, IL - Received
- July 26, 2024
- Decision date
- November 22, 2024
- 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 |
|---|---|---|
| K261317 | BriefCase-TriageQAS · Special | 05/14/2026SE |
| K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large…QAS · Traditional | 02/26/2026SE |
| K251195 | BriefCase-TriageQAS · Traditional | 01/27/2026SE |
| K252970 | BriefCase-Triage: CARE Multi-triage CT BodyQAS · Traditional | 01/07/2026SE |
| K253265 | BriefCase-TriageQAS · Special | 11/06/2025SE |
| K251406 | BriefCase-TriageQAS · Special | 05/30/2025SE |
| K250248 | BriefCase-TriageQAS · Special | 02/14/2025SE |
| K243548 | BriefCase-TriageQFM · Special | 12/11/2024SE |
| K242837 | BriefCase-TriageQAS · Special | 10/18/2024SE |
| K241727 | BriefCase-TriageQAS · Special | 07/12/2024SE |
Questions and answers
When was BriefCase-Quantification cleared by the FDA?
BriefCase-Quantification (K242203) received a 510(k) decision of Substantially Equivalent on November 22, 2024, 119 days after the submission was received.
What is the product code of K242203?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.