Red Dot Radiological Computer-Assisted Prioritization Software
by Behold.Ai Technologies Limited
510(k) K191556
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191556 | Date28 Feb 2020 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Red Dot
- 510(k) Number
- FDA Product Code
- QFM
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2080
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Red Dot is a Radiological Computer-Assisted Prioritization Software designed to assist radiologists in identifying and prioritizing lesions within medical imaging studies. Classified as a Class II device under FDA regulations, it leverages AI algorithms to enhance diagnostic workflows by flagging potential abnormalities for further review, thereby supporting more efficient and accurate lesion assessment in radiology.
Supplied as a digital software solution, the Red Dot operates in radiology settings and is intended for single-use per imaging session. It requires no physical sterilization but must be used in compliance with FDA-cleared specifications (K191556, QFM). The device is regulated under 21 CFR 892.2080 and has received a Traditional 510(k) clearance from the FDA Radiology Advisory Committee. No third-party reprocessing is applicable, as it is a software-based tool.
Questions
AI-generated answers, 1 Oct 2026
What is the Red Dot software designed to do in radiology workflows?
The Red Dot is a Radiological Computer-Assisted Prioritization Software that uses AI algorithms to analyze medical imaging studies and flag potential abnormalities or lesions for radiologists to review. This helps streamline diagnostic workflows by highlighting areas that may require further attention, improving efficiency and accuracy in lesion assessment.
How is the Red Dot supplied and used in clinical settings?
The Red Dot is supplied as a digital software solution, meaning it is not a physical device but rather a cloud-based or locally installed tool. It is intended for single-use per imaging session, meaning each new imaging study requires the software to be applied fresh without carryover from prior sessions. No physical sterilization is required, but it must be used strictly in compliance with FDA-cleared specifications.
Is the Red Dot software reusable or single-use, and why?
The Red Dot is designed for single-use per imaging session. This approach ensures that the software’s AI-driven analysis is tailored to the specific study being reviewed, without any risk of data contamination or carryover from previous cases. Since it operates digitally, there is no physical degradation or need for reprocessing, making single-use both practical and safe for clinical use.
Does the Red Dot require sterilization, and if not, how is its safety ensured?
The Red Dot does not require physical sterilization because it is a software-based tool with no physical components that could harbor pathogens. Its safety is ensured through compliance with FDA-cleared specifications (K191556, QFM) and adherence to regulatory guidelines under 21 CFR 892.2080. The software’s AI algorithms are validated to meet performance standards, and its use is governed by the same rigorous controls as other Class II medical devices.
What regulatory pathway does the Red Dot follow, and who oversees its compliance?
The Red Dot follows the Traditional 510(k) clearance pathway under the FDA’s Radiology Advisory Committee (RA). It was granted clearance as substantially equivalent to a predicate device and is regulated under 21 CFR 892.2080. Compliance is overseen by the FDA, ensuring the software meets performance and safety standards for radiology applications. No third-party reprocessing is applicable, as it is a software-only solution.