Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes image processing and quantitative analysis of medical images, but there is no mention of AI, ML, deep learning, or any related terms. The focus is on calculating specific metrics from the MR data.

Therapeutic

No
CoverScan is described as a medical image management and processing software that provides measurements and metrics from medical images to assist in diagnosis, clinical management, and monitoring. It does not actively treat or cure a disease or condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section states that the metrics derived from the images, "when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients." This explicitly indicates a diagnostic purpose.

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as a "software package" and a "post-processing software system comprised of several software modules." It is installed on general-purpose workstations and hosted on AWS, with no mention of proprietary hardware components being part of the device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
CoverScan's Function: CoverScan is a software package that processes and analyzes medical images (specifically MR data) acquired from within the patient's body. It does not analyze samples taken from the body.
Intended Use: The intended use clearly states it's for the display, analysis, and post-processing of DICOM compliant medical images and MR data. It derives metrics from these images, which are then interpreted by a physician.
Device Description: The device description reinforces that it uses acquired MR data to produce metrics.

While the metrics derived from the images may assist in diagnosis, the device itself is not performing a diagnostic test on a biological sample. It's a tool for analyzing imaging data.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

CoverScan is a medical image management and processing software package that allows the display, analysis and post-processing of DICOM compliant medical images and MR data.

CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney.

CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time (T1, cT1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration).

These metrics derived from the images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients.

CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T and 3T MRI scanners.

Product codes

LLZ

Device Description

CoverScan is a post-processing software system comprised of several software modules. It uses acquired MR data to produce metrics of quantified tissue characteristics of the heart, lungs, liver, kidneys, pancreas and spleen.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MR data, MRI

Anatomical Site

heart, lungs, liver, spleen, pancreas and kidney.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Metrics produced by CoverScan can be used by healthcare professionals (HCPs) in a clinical setting for the purposes of assessing multiple organs.

The intended device users are trained Perspectum internal operators. Operators use CoverScan to conduct quantitative analysis of tissue characteristics and function to produce a quantitative report. The end-users for the output from the device, the report, are clinicians who receive and interpret reports.

Installation of Modules 1-5 of CoverScan are installed on general purpose workstations at Perspectum's image analysis centre by specialist members of staff. Workstations need to meet the minimum technical requirements.

Module 6 of CoverScan is hosted on Amazon Web Services (AWS) there is no user interface for these modules.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Internal verification and validation testing confirms that the product specifications are met. All of the different components of the CoverScan software have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate according to its intended use.

The main groups of tests performed include:
Product Risk Assessment
Software modules verification tests
Software validation test

Device performance was assessed with purpose-built phantoms and in-vivo acquired data from volunteers covering a range of physiological values for sT1, cT1, T1 and PDFF.
The change to add the Siemens 3T Scan data was made and performance testing using well established methods demonstrated equal performance between the subject and the predicate.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K212565

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

March 3, 2023

Perspectum Ltd. % Ioan Wigley Head of Regulatory Affairs Gemini One 5220 John Smith Drive Oxford, Oxfordshire OX4 2LL United Kingdom

Re: K230294

Trade/Device Name: CoverScan (CoverScan v1.1) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: November 28, 2022 Received: February 2, 2023

Dear Ioan Wigley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Dghk

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

Submission Number (if known)

K230294

Device Name

CoverScan (CoverScan v1.1)

Indications for Use (Describe)

CoverScan is a medical image management and processing software package that allows the display, analysis and post-processing of DICOM compliant medical images and MR data.

CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart. lungs. liver, spleen, pancreas and kidney.

CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time (T1. srT1. T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration).

These metrics derived from the images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients.

CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T and Siemens 3T MRI scanners.

Type of Use (Select one or both, as applicable)

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

RA0913

Image /page/3/Picture/2 description: The image shows the logo for Perspectum. The word "Perspectum" is written in a bold, sans-serif font in blue color. To the right of the word is a circular graphic divided into four colored sections: light blue, green, pink, and dark blue. The logo has a clean and modern design.

K230294

Date Prepared:	28 November 2022
----------------	------------------

Submitter Details

Owner Address: Gemini One, 5520 John Smith Drive, Oxford Business Park, Oxford. OX4 2LL

Perspectum Ltd

Contact Person:

loan Wigley

Subject and Predicate Device

	Predicate Device	Subject Device
510(k) number	K212565	Unknown
Legal Manufacturer	Perspectum Ltd.	Perspectum Ltd.
Owner/Operator Number	10056574	10056574
Device Name	CoverScan v1.0	CoverScan v1.1
Proprietary/Common name	CoverScan	CoverScan
510k Review Panel	Radiology	Radiology
Regulation Number	892.2050	892.2050
Risk Class	Class II	Class II
Product Class code	LLZ	LLZ
Classification	System, Image Processing, Radiological	System, Image Processing, Radiological

Device Name

Device Trade Name	Common Name
CoverScan v1.1	CoverScan, CoverScan v1

Device Description

CoverScan is a post-processing software system comprised of several software modules. It uses acquired MR data to produce metrics of quantified tissue characteristics of the heart, lungs, liver, kidneys, pancreas and spleen.

4

Image /page/4/Picture/1 description: The image shows the word "Perspectum" in a bold, sans-serif font. The word is colored in a dark blue. To the right of the word is a circular logo that is divided into four sections. The top three sections are colored light blue, green, and pink, while the bottom section is colored dark blue.

Metrics produced by CoverScan can be used by healthcare professionals (HCPs) in a clinical setting for the purposes of assessing multiple organs.

CoverScan v1.1 is a new version of CoverScan that supports the use of Siemens 3T scan data to enable more scan sites to utilise CoverScan.

Intended Use

CoverScan is a medical image management and processing software package that allows the display, analysis and post-processing of DICOM compliant medical images and MR data.

CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney.

CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time (T1, cT1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration).

These metrics derived from the images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients.

Indications for use

CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T and 3T MRI scanners.

Substantial equivalence

The modified CoverScan v1.1 device has the following similarities to the previously cleared CoverScan v1 device.

Characteristic	Subject and Predicate Device Comparison
	CoverScan v1.0 (Predicate device)	CoverScan v1.1 (Subject Device)
Product Code	LLZ	LLZ
Regulation
Number	892.2050	892.2050
Class	II	II
Intended Use &
Indications for
Use	CoverScan is a medical image
management and processing software
package that allows the display, analysis
and postprocessing of DICOM compliant
medical images and MR data.
CoverScan provides both viewing and
analysis capabilities to ascertain quantified
metrics of multiple organs such as the
heart, lungs, liver, spleen, pancreas and
kidney.
CoverScan provides measurements in
different organs to be used for the
assessment of longitudinal and transversal
relaxation time and rate (T1, SR-T1, cT1, T2),
fat content (proton density fat fraction or
PDFF) and metrics of organ function (e.g.,
left ventricular ejection fraction and lung
fractional area change on deep
inspiration).
These metrics derived from the images,
when interpreted by a licensed physician,
yield information that may assist in
diagnosis, clinical management and
monitoring of patients.	CoverScan is a medical image
management and processing
software package that allows the
display, analysis and post-processing
of DICOM compliant medical images
and MR data.
CoverScan provides both viewing
and analysis capabilities to ascertain
quantified metrics of multiple organs
such as the heart, lungs, liver, spleen,
pancreas and kidney.
CoverScan provides measurements
in different organs to be used for the
assessment of longitudinal and
transversal relaxation time (T1, SR-T1,
cT1, T2), fat content (proton density
fat fraction or PDFF) and metrics of
organ function (e.g., left ventricular
ejection fraction and lung fractional
area change on deep inspiration).
These metrics derived from the
images, when interpreted by a
licensed physician, yield information
that may assist in diagnosis, clinical
management and monitoring of
patients.
Indications for
use	CoverScan is not intended for
asymptomatic screening. This device is
intended for use with Siemens 1.5T MRI
scanners	CoverScan is not intended for
asymptomatic screening. This device
is intended for use with Siemens 1.5T
and Siemens 3T MRI scanners.
The Subject device underwent additional performance testing to show that the performance was the
same as the predicate.
Limitations of
Use	Indicated where MRI is not
contraindicated.	Same as predicate
Device Users	Trained Perspectum internal operators.	Same as predicate
Use Environment	Installation of Modules 1-5 of CoverScan
are installed on general purpose
workstations at Perspectum's image
	Module 6 of CoverScan is hosted on
Amazon Web Services (AWS) there is no
user interface for these modules.
Clinical Setting	CoverScan is a software device that is
intended to be installed on general
workstations at Perspectum's image
centre. The intended device users will log
on to the workstations, access the device,
and use the device on general-use HD
monitors.
CoverScan is a post-processing software,
the intended device users are trained
Perspectum internal operators. Operators
use CoverScan to conduct quantitative
analysis of tissue characteristics and
function to produce a quantitative report.
The end-users for the output from the
device, the report, are clinicians who
receive and interpret reports.	Same as predicate
Principles of
Operation	CoverScan offers comprehensive
functionality for image analysis and
visualisation, CoverScan contains multiple
modules for the quantitative analysis of
tissue characteristics and function.
Visualisation and quantification tools for
image analysis depend on the module.	Same as predicate
	Module 1 (Liver module)
cT1
Full segmentation of the outer liver
contour and liver vasculature of the cT1
parametric map.
ROI placed method on the cT1 map with
IQR and median metrics from the placed
ROIs potentially across multiple acquired
slices.
PDFF
Full liver segmentation of the PDFF
parametric map where IQR and median
metrics are reported from the
segmentation.
ROI placed method on the PDFF map with
IQR and median metrics from the placed
ROIs potentially across multiple acquired
slices	Same as predicate

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Image /page/5/Picture/1 description: The image shows the word "Perspectum" in a bold, dark blue font. To the right of the word is a circular logo that is divided into several colored sections. The top half of the circle is divided into three sections colored light blue, green, and pink. The bottom half of the circle is a solid dark blue color.

analysis centre by specialist members of staff. Workstations need to meet the minimum technical requirements.

Same as predicate.

6

Image /page/6/Picture/1 description: The image shows the word "Perspectum" in a bold, sans-serif font. The word is in a dark blue color. To the right of the word is a circular logo that is divided into four sections. The top left section is light blue, the top right section is pink, the bottom section is dark blue, and the middle section is green.

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Image /page/7/Picture/1 description: The image shows the word "Perspectum" in a dark blue font. To the right of the word is a circular logo that is divided into four colored sections: light blue, green, pink, and dark blue. The dark blue section of the logo also contains a smaller, concentric circle within it.

| PDFF parametric maps are calculated

using the LMS IDEAL method (1)
Module 2 (Pancreas module)
sT1
ROI placed method on the T1 map with IQR
and median metrics from the placed ROIs
potentially across multiple acquired slices
PDFF
ROI placed method on the PDFF map with
IQR and median metrics from the placed
ROIs potentially across multiple acquired
slices
PDFF parametric maps are calculated
using the LMS IDEAL method (1)	Same as predicate
Module 3 (Kidney module)
T1
ROI placed method on the T1 map with IQR
and median metrics from the placed ROIs
potentially across multiple acquired slices	Same as predicate
Module 4 (Cardiac function module)
Operators may use modules within
CoverScan to analyse and quantify cardiac
images with the below capabilities:
Left Ventricular function
Ejection fraction
End Diastolic Volume – left ventricle
End Systolic Volume - left ventricle	Same as predicate

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Image /page/8/Picture/1 description: The image shows the word "Perspectum" in a bold, dark blue font. To the right of the word is a circular logo that is divided into four sections. The top three sections are colored light blue, green, and pink, while the bottom section is dark blue. The logo is meant to represent a global perspective.

| | Stroke Volume
Left Ventricle Muscle Mass
Left Ventricular Wall Thickness
Global and regional LV function and
volume analysis
Global RV function analysis
T1 mapping Module
Assessment of native and post contrast T1
Relaxation times T1, T1and R2 maps with
customizable color LUT and polar map
display
Assessment of ECV % per slice and
segment including polar map display and
map generation with customizable color
LUT
T2 Mapping Module
Global and Regional Segmental T2 times | |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| | Module 5 (Lung)
Basic calculations to determine the
percentage change in area from
inspiration to expiration from datasets
exported from analysis conducted in Osirix
MD. | Same as predicate |
| | Module 6 (Metric consolidation)
A compiled clinical report containing
metrics from modules 1-5, rounding of
these numbers along with a reference
range. Basic logic algorithm applied to
determine if there is evidence of heart
impairment from cardiac metrics exported
from analysis conducted. | Same as predicate |
| Performance
Features | Main software features:
Post-processing, display and allow
manipulation of medical MR images
Image loading and saving
Session file loading and saving
Image viewing
Image manipulation
Image analysis
Image processing
Relaxometry post-processing
Fat fraction postprocessing
Segmentation of regions of interest | Same as predicate |
| Design: MR
Relaxometry | Relaxometry post-processing (T1, T2 and
T2). And subsequently cT1 and sT1. | Same as predicate |
| Design: Liver Fat
Quantification | Fat fraction postprocessing (PDFF) | Same as predicate |
| Design:
Parametric Maps | An operator can use modules 1-3 of
CoverScan to generate T2*, T2 and T1
relaxometry maps fitted from an
appropriate set of MR Inversion Recovery
images which are Gradient Echo (GRE) and
MOLLI acquisition protocols respectively.
Modules within CoverScan may also be
used to generate fat signal fraction (PDFF)
maps calculated from an appropriate set of
MR GRE images using the IDEAL (iterative
decomposition of water and fat with echo
asymmetric and least-squares estimation)
methodology (13).

Module 5 within CoverScan can be used to
calculate percentage change in area from
inspiration to expiration change using the
interface that offers tools:

3D rendering tools, such as Multiplanar
Reconstructions, Curved Reconstructions,
3D Volume Rendering, 3D Surface
Rendering, 3D Endoscopy
3D sculpting tools
Measure distance in 3D Volume
Rendering, 3D Curved-MPR or 3D
Orthogonal MultiPlanar
3D rigid registration

Module 4 within CoverScan can be used to
analyse and calculate cardiac metrics to
report:
Left Ventricular function

Ejection fraction
End Diastolic Volume – left ventricle
End Systolic Volume – left ventricle
Stroke Volume
Left Ventricle Muscle Mass
Left Ventricular Wall Thickness
Global and regional LV function and
volume analysis
Global RV function analysis
Assessment of native and post contrast T1
Relaxation times T1, T1* and R2 | Same as predicate |
| | Assessment of ECV % per slice and
segment
Global and Regional Segmental T2 times | |
| Design:
Visualisation | Offers numerous views within modules 1-5
of the CoverScan interface can be used to
assist in analysis, T1, T2* and Proton
Density Fat Fraction (PDFF)) parametric
maps can be created from all supported
scanners. R2 maps can also be utilised to
assess the quality of the map fitting.
Colormaps in the parametric maps are
designed to have maximum contrast on
organ tissue. | Same as predicate |
| Design:
Outputted data | Quantified metrics and images derived
from the analysis of liver tissue
characteristic on parametric maps are
collated into a datafile that may
subsequently be assembled into a report
for evaluation and interpretation by a
clinician.
Based on the placed ROI's (during analysis
in Modules 1-3), for each metric the median
and IQR are given as well as a 'reference
range'. | Same as predicate |
| Design:
Supported
Modalities | DICOM 3.0 compliant MR data from
supported MRI scanners. | Same as predicate |
| Performance
Testing | Perspectum has conducted extensive
validation testing of CoverScan, a medical
image management and processing
system (MIMPS), that is capable of
providing reliable post-processing and
display of images for instantaneous multi-
parametric analysis.

Internal verification and validation testing
confirms that the product specifications
are met.

All of the different components of the
CoverScan software have been stress
tested to ensure that the system as a
whole provides all the capabilities
necessary to operate according to its
intended use.

The main groups of tests performed
include:
Product Risk Assessment
Software modules verification tests
Software validation test

9

RA0913

Image /page/9/Picture/2 description: The image shows the word "Perspectum" in a bold, blue font. To the right of the word is a circular logo. The logo is divided into four sections, with the top three sections colored light blue, green, and pink, respectively, and the bottom section colored dark blue.

10

Image /page/10/Picture/1 description: The image shows the word "Perspectum" in a bold, blue font. To the right of the word is a circular logo. The logo is divided into four colored sections: light blue, green, pink, and dark blue.

11

RA0913

Image /page/11/Picture/2 description: The image shows the word "Perspectum" in a bold, sans-serif font. The word is a dark blue color. To the right of the word is a circular logo that is divided into four sections. The top three sections are light blue, green, and pink, while the bottom section is dark blue.

12

Image /page/12/Picture/1 description: The image shows the word "Perspectum" in a bold, dark blue font. To the right of the word is a circular logo. The logo is divided into four colored sections: light blue, green, pink, and dark blue.

The change to add the Siemens 3T Scan data was made and performance testing using well established methods demonstrated equal performance between the subject and the predicate. In summary, CoverScan v1.1 is substantially equivalent to the predicate device CoverScan v1.0 (K212565).

Conclusion

The subject device does not result in any new potential safety risk when compared to the chosen predicate device and it performs in accordance with its use characteristics and intended use. Based upon comparison of devices and performance testing results CoverScan v1.1 is substantially equivalent to the listed predicate device.