Image Acquisition And/Or Optimization Guided By Artificial Intelligence
The Image Acquisition And/Or Optimization Guided By Artificial Intelligence is a Class 2 radiology device intended to aid in the acquisition and/or optimization of radiological images and diagnostic signals by analyzing system output and providing guidance or feedback to the operator for improving image quality. It requires 510(k) clearance and is regulated under 21 CFR 892.2100 within the Radiology medical specialty. The product code is QJU. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QJU
- Device Class
- FDA class 2
- Regulation Number
- 892.2100
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
Definition
A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260780 | HeartFocus | Jun 03, 2026 | Substantially Equivalent | Deski |
| K251416 | UltraSight Guidance | Dec 17, 2025 | Substantially Equivalent | Ultrasight , Ltd. |
| K242807 | HeartFocus (V.1.1.1) | Apr 04, 2025 | Substantially Equivalent | Deski |
| K243065 | Cardiac Guidance | Jan 15, 2025 | Substantially Equivalent | Caption Health, Inc. |
| K223347 | UltraSight AI Guidance | Jul 24, 2023 | Substantially Equivalent | Ultrasight, Inc. |
| K201992 | Caption Guidance | Sep 18, 2020 | Substantially Equivalent | Caption Health |
| K200755 | Caption Guidance | Apr 16, 2020 | Substantially Equivalent | Caption Health |
| DEN190040 | Caption Guidance | Feb 07, 2020 | Unknown | Bay Labs, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.