Device Information

Device Specifications:
BreView is an advanced visualization tool designed for radiologists to optimize MR breast data review and assessment. It provides functionalities like 2D, 3D, and 4D image loading, automated motion correction, image subtraction, and multi-planar reformats. It also includes semi-automated segmentation tools, a graph view for multi-phase datasets, and the ability to export data via DICOM Secondary Captures.

Indications

BreView is intended to help clinicians with the review of multi-parametric breast magnetic resonance images. This tool combines acquired images, reconstructed images, annotations, and measurements to aid in diagnosis and treatment planning.

• Indication with MedDRA Code: MR breast imaging analysis – MedDRA code: Not specified in the document.

Intended Use

BreView is for trained healthcare professionals to assist in breast MR image assessment. It is intended for diagnostic purposes, but the final assessment is the clinician’s responsibility based on professional judgment and state-of-the-art practices.

Availability

Prescription only.

Study Results

• Nonclinical and Safety Testing: The device underwent verification, validation, and safety testing according to GE HealthCare’s quality systems and the DICOM standards. Testing included risk analysis, technical design reviews, software development, and bench testing to confirm that the non-rigid registration algorithm functions correctly.

Regulatory Information

• Regulation Number: 21 CFR 892.2050
• Regulatory Class: Class II
• Product Code: LLZ
• 510(k) Number: K233714

The device must follow several regulations, including quality system regulations, medical device reporting under 21 CFR Part 803, and DICOM standards for medical imaging.

Manufacturer Information

• Name: GE Medical Systems SCS
• Address: 283 rue de la Miniere, 78530 Buc, France
• Primary Contact: Indu Karun, Regulatory Affairs Leader
• Secondary Contact: Camille Vidal, Senior Director Regulatory Affairs

Predicate Device Information

• Primary Predicate Device: READY View (K113456)
• Secondary Predicate Device: Integrated Registration (K093234)
• Both BreView and READY View perform multi-parametric MR imaging. However, BreView focuses solely on breast imaging, whereas READY View supports a broader range of anatomies. The main difference is that BreView allows image subtraction without requiring non-rigid registration, which READY View does not.

Implications

BreView offers a workflow for radiologists, enabling faster and more efficient breast MR data review. However, its use is limited to trained professionals, and it requires clinical interpretation.

References

1. BreView. K233714. GE Medical Systems SCS: FDA summary: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K233714
2. https://medicaldevices.icij.org/manufacturers/swedish-medical-products-agency-ge-medical-systems-scs
3. https://www.gehealthcare.com/-/jssmedia/documents/us-global/products/interoperability/dicom/gehc-dicom-conformance_advancedvisapps_doc2850967_rev1.pdf