July 2017 – Drug and Device Digest

FDA Clearance, Classification: EMBRACE MRI, QUANTX

FDA BRIEF: Week of July 24, 2017

EMBRACE Neonatal MRI System

Aspect Imaging Ltd.


Used on neonates with a head circumference up to 38 centimeters and weight between 1 and 4.5 kilograms. The system has a temperature-controlled incubator placed directly into the MRI system, minimizing movement of the baby. If urgent access to the baby is necessary during the imaging process, the baby can typically be removed from the system in less than 30 seconds.


  • First magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)
  • No need to take babies out of the NICU
  • Safer imaging


  • Device Classification Name: Nuclear MRI System
  • Regulation Number: 892.100
  • Classification Product Code: LNH
  • Subsequent Product Code: MOS


  • Does not require a safety zone or a radiofrequency shielded room
  • Fully enclosed, medical device implants in close proximity to the system are not required to be “MR Conditional” or “MR Safe.”
  • Contraindicated for patients weighing more than 4.5 kilograms or with a head circumference of more than 38 centimeters
  • Contraindicated for all infants with metallic or electronically active implants since the MRI may cause tissue near the implant to heat or the implant to malfunction


  • Efficacy: Non-clinical testing including images of phantoms simulating an infant brain- of sufficient quality for use by an independent board-certified radiologist
  • Safety: Performance testing – electrical and mechanical safety measures


Quantitative Insights, Inc


Computer-aided diagnosis (CADx) software device used to assist radiologists in the assessment and characterization of breast abnormalities using MR image data. The software automatically registers images, and segments and analyzes user-selected regions of interest (ROI). QuantX extracts image data from the ROI to provide volumetric analysis and computer analytics based on morphological and enhancement characteristics. These imaging (or radiomic) features are then synthesized by an artificial intelligence algorithm into a single value, the QI score, which is analyzed relative to a database of reference abnormalities with known ground truth.

QuantX is indicated for evaluation of patients presenting for high-risk screening, diagnostic imaging workup, or evaluation of extent of known disease. Extent of known disease refers to both the assessment of the boundary of a particular abnormality as well as the assessment of the total disease burden in a particular patient. In cases where multiple abnormalities are present, QuantX can be used to assess each abnormality independently.

This device provides information that may be useful in the characterization of breast abnormalities during image interpretation. For the QI score and component radiomic features, the QuantX device provides comparative analysis to lesions with known outcomes using an image atlas and histogram display format.

QuantX may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software also includes tools that allow  users to measure and document images, and output in a structured report.

Limitations: QuantX is not intended for primary interpretation of digital mammography images.

REG PATHWAY: De Novo request

  • Regulation Number: 21 CFR 892.2060
  • Regulation Name: Radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer
  • Regulatory Class: Class II
  • Product Code: POK

GENERIC DEVICE TYPE: Radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer.

  •  image processing device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography
  • characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user
  • diagnostic and patient management decisions are made by the clinical user


  • Incorrect lesion(s) characterization leading to false positive results
  • Incorrect lesion(s) characterization leading to false negative results
  • Misused to analyze images from an unintended patient population or on images acquired with incompatible imaging hardware
  • Device failure could lead to the absence of results, delay of results or incorrect results


  • General Controls and Special Controls

Image Credits: Aspect Imaging, Quantitative Insights

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