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Radiography 7300 C

Philips Medical Systems DMC GmbH • Radiology • 06/13/2024

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

The Philips Radiography 7300 C is an advanced digital X-ray system designed to enhance general radiographic imaging through artificial intelligence, focusing on improving workflow efficiency and diagnostic image quality. Its core methodology involves AI-driven features like automated collimation and bone suppression to expedite procedures and improve lesion detectability, particularly for lung nodules, without additional radiation.

Summary

The Philips Radiography 7300 C is a ceiling-mounted digital X-ray system engineered for general radiographic procedures, such as chest and orthopedic examinations. Its design incorporates a ceiling-suspended X-ray tube, a flat-panel detector, and versatile patient positioning options (table or wall stand) to optimize imaging. Philips aims for this system to boost patient throughput and elevate diagnostic confidence in clinical environments by combining swift image acquisition with automated workflow enhancements. This fully digital DR system, operating on the Philips Eleva platform, integrates artificial intelligence to significantly improve both operational efficiency and the diagnostic quality of images. A key AI feature, "Smart Collimation Thorax," employs a 3D camera to automatically adjust detector height and suggest optimal X-ray collimation for upright chest exams, which reportedly reduces procedure time by approximately 35 seconds. Additionally, Philips Bone Suppression, a deep-learning algorithm, digitally removes bone superimposition from chest X-rays, generating a supplementary soft-tissue image without necessitating extra radiation exposure, a technique shown in studies to enhance radiologists' ability to detect lung nodules.

AI Regulatory Concerns

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

Keywords

Digital RadiographyX-ray SystemArtificial IntelligenceWorkflow EfficiencyImage QualitySmart CollimationBone SuppressionLung Nodule DetectionDiagnostic ImagingPhilips Eleva Platform

Device Metadata

Submission Number
K233662
Company
Philips Medical Systems DMC GmbH
Panel
Radiology
Product Code
N/A
Data Type
Images
Clinical Function
Assessment
AI Function
Generation
AI Subclass
acquisition guidance

Relevant Clinical Questions

  • Q1. What is the quantitative impact of 'Smart Collimation Thorax' on overall examination time and technologist workload beyond the reported 35-second saving per procedure?; How does the performance of Philips Bone Suppression compare to other existing bone suppression algorithms or dual-energy subtraction techniques in terms of lung nodule detection sensitivity and specificity across diverse patient populations?; Are there specific patient cohorts or examination types where the AI-driven features (Smart Collimation, Bone Suppression) demonstrate more significant benefits or potential limitations?; What is the learning curve for technologists to effectively utilize the AI-powered features, and what training protocols are recommended by Philips to ensure optimal system use?; Beyond lung nodule detection, what other potential clinical applications or diagnostic improvements could be realized using the supplementary soft-tissue images generated by Philips Bone Suppression?

Risk Classification

ESL Analysis
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

Powered by SBOMator™

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 Score20/100
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)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials(platform)
✓ Detected
HBOMHardware Bill of Materials(camera)
✓ Detected
CBOMCryptography Bill of Materials
- Not detected
VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange
- Not detected
OBOMOperations Bill of Materials(environment, operational)
✓ 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, HBOM, OBOM 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, CBOM, VDR/VEX. These may be present in the full FDA submission.

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Radiography 7300 C - Philips Medical Systems DMC GmbH | ESL FDA AI Device Intelligence