Imbio PHA (4.0.0)

Imbio, Inc • Radiology • 08/30/2024

510(k)IEC 62304 Class B

Device Purpose

Imbio PHA (4.0.0) is a software device classified as a Medical Image Management And Processing System. The document outlines regulatory obligations and controls applicable to this system, including quality system requirements and labeling standards.

Summary

The document pertains to the Imbio PHA (4.0.0), a device identified as a Medical Image Management And Processing System under regulation 21 CFR 892.2050, with product code QIH. This software is intended for use in medical image management and processing, falling under the category of Class II devices. The correspondence addresses Imbio, Inc. regarding this system, which is associated with the Division of Radiological Imaging Devices and Electronic Products and the Office of Radiological Health. The communication outlines that the device is subject to general controls provisions, including requirements for annual registration, device listing, good manufacturing practices, and truthful, non-misleading labeling. It further specifies that the device must adhere to Quality System (QS) regulations (21 CFR Part 820), encompassing design controls, management of nonconforming products, and corrective and preventive actions. The manufacturer is also reminded of obligations related to medical device reporting for adverse events and compliance with electronic product radiation control provisions if applicable.

AI Regulatory Concerns

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

Imbio PHAMedical Image ManagementImage Processing SystemRadiological ImagingSoftwareMedical DeviceProduct Code QIHVersion 4.0.0Imaging SoftwareQuality System Regulation

Device Metadata

Submission Number

K241847

Company

Imbio, Inc

Panel

Radiology

Product Code

N/A

Data Type

Images

Clinical Function

Assessment

AI Function

Analysis

AI Subclass

quantification/feature localization

Relevant Clinical Questions

Q1. What specific types of medical images is Imbio PHA (4.0.0) designed to manage and process?; What are the core image processing algorithms or analytical capabilities offered by Imbio PHA (4.0.0)?; For what specific clinical conditions or anatomical regions is the Imbio PHA (4.0.0) system primarily intended to provide image management and processing support?; What are the technical specifications for integrating Imbio PHA (4.0.0) with existing hospital IT infrastructure, such as PACS or RIS?; Are there any published studies or performance data demonstrating the accuracy, efficiency, or clinical utility of the Imbio PHA (4.0.0) system?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Post-§524B but no clear network capability detected

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Cybersecurity Evidence

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score10/100

SBOM Evidence⚠ Not in summary - likely in full submission per §524B

Cyber Risk Assessment⚠ Not in summary - likely in full submission per §524B

Postmarket Plan⚠ Not in summary - likely in full submission per §524B

§524B ApplicableYes

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials

- Not detected

ML-BOMMachine Learning Bill of Materials(algorithm, labeling)

✓ Detected

SaaSBOMSoftware-as-a-Service Bill of Materials(infrastructure)

✓ Detected

HBOMHardware Bill of Materials

- Not detected

CBOMCryptography Bill of Materials

- Not detected

VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange

- Not detected

OBOMOperations Bill of Materials

- Not detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of ML-BOM, SaaSBOM detected in AI-generated device summary.

• SBOM not mentioned in AI-generated device summary. Under §524B (effective Oct 2023), cyber devices must provide a SBOM.

• Cybersecurity risk assessment not referenced in AI-generated device summary. FDA cybersecurity guidance (2023) expects this for cyber devices.

• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.

• Not detected in AI-generated device summary: SBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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