DC Neuro is an image processing software package designed to run on standard PC hardware (workstation). The required workstation hardware consists of standard, "off-the-shelf" computer components. DC Neuro software receives image data from medical imaging devices such as Magnetic Resonance Imaging systems or from image archives, PACS. DC Neuro can be used to perform image viewing, image manipulation, image quantification, communication, and printing.

DC Neuro provides both analysis and viewing capabilities which integrate both anatomical and physiologic/functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic analysis, and vessel analysis in both 2D and/or 3D views.

BOLD fMRI: The BOLD analysis is useful in quantifying small susceptibility changes in the human brain, created by the execution of a specific task.

Diffusion/Fiber tracking: The diffusion of water molecules through brain tissue can be measured with diffusion-weighted MRI scanning. Actual diffusion properties depend on the local tissue. With fiber tracking, the directional dependency can be used to visualize the white matter structure in the brain.

Dynamic Analysis: Dynamic analysis is intended for visualization and analysis of MR dynamic studies, showing changes in contrast over time, where such techniques are useful or necessary.

Vessel Analysis: Allows the visualization of vascular morphology from MR images.

3D Visualization: 3D rendering allows the visualization of bone, vascular structures, and selected anatomy as three dimensional object surfaces projected on a flat screen.

Device Description

DC Neuro is a software package available for viewing, printing, storing, transferring, and quantifying DICOM magnetic resonance imaging (MRI) studies. The DC Neuro software is able to run on "off the shelf" standard PC components using the Microsoft Windows XP Professional Operating Software.

DC Neuro provides both analysis and viewing capabilities that integrate both anatomical and physiologic/functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic analysis, and vessel analysis in both 2D and/or 3D views.

DC Neuro software provides automated processing of DICOM images. Imaging cxams are transferred to the DC Neuro system in DICOM format either directly from the MR system or from a picture archiving and communications system (PACS) or via supported digital media. The DC Neuro system reads the incoming image headers and automatically sorts the images into exams consisting of multiple data sets. Pre-set processing algorithms may be performed on the incoming data as defined by the user such as image co-registration, fMRI analysis, diffusion analysis, dynamic analysis, vessel analysis, and 3D displays.

DC Neuro is a software package that uses standard PC hardware, with a standard uscr/operator interface (keyboard and mouse), and a standard Operating System: Microsoft Windows XP Professional.

AI/ML Overview

The provided text is a 510(k) summary for the Invivo Corporation's DC Neuro device. It outlines the device's functions, intended use, and claims substantial equivalence to predicate devices. However, the document does not contain any information about a study proving the device meets specific acceptance criteria.

The 510(k) submission process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies against pre-defined acceptance criteria. The document states: "No new hazards are introduced by Invivo Corporation's DC Neuro, as compared to predicated devices and image processing functionality," and concludes that "Invivo Corporation's DC Neuro is substantially equivalent to the Philips ViewForum 2003 workstation, and the Philips BOLD fMRI. Diffusion/Fiber Tracking, Dynamic and Vessel Analyses, and 3D visualization image processing functionality."

Therefore, based solely on the provided text, I cannot complete the requested tables and answer the questions related to acceptance criteria and a study proving their fulfillment. The information necessary to do so is absent from this 510(k) summary.

In summary, the provided document does not include:

A table of acceptance criteria or reported device performance against such criteria.
Information about sample sizes for test sets or data provenance.
Details about the number or qualifications of experts used for ground truth.
Adjudication methods for a test set.
A multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with AI assistance.
A standalone (algorithm only) performance study.
The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
The sample size for the training set.
How the ground truth for the training set was established.

Summary

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Invivo Corporation - DC Neuro Premarka Notification [510(k)] Submission

K081242
pg. 1 of 3

510(K) SUMMARY

This summary is being submitted in accordance with 21 CFR 807.92.

1. GENERERAL INFORMATION

1.1. Submitter Information

Manufacturer's Name: Address:

Invivo Corporation N27 W23676 Paul Road Pewaukee, WI 53072 2183683.

treiskertajnvivocorp.com

JUN 1 7 2008

Establishment Registration #

1.2. Contact Person Name and Information

Contact:	Theodore J. Reisker
Title:	Director, Product Development
Company:	Invivo Corporation
Address:	N27 W23676 Paul Road
	Pewaukee, WI 53072
Telephone #	(262) 524-1402 ext. 175
Facsimile #:	(262) 524-1403

1.3. Trade name and common name of device

Trade name:	DC Neuro
Common name:	Image Processing System

1.4. Classification of the device

Classification:	Image Processing System, 21 CFR 892.2050
Class:	Class II
Procode:	LLZ

1.5. Predicate Devices

E-mail:

Table 1 summarizes the correspondence between various features in DC Neuro and predicate devices, along with the pertinent 510(k) submission references.

Feature	Predicate Device Name	Predicate510(k)SubmissionReference
Diffusion / FiberTrak	Philips Achieva, Intera, & Panorama 1.0T	K052078
BOLD / fMRI	Philips EasyVision Family WorkstationOption - BOLD Analysis Package	K990329
Dynamic Analysis,Vessels Analysis	Philips Quantitative Analysis Package	K971965
3D Rendering	Philips EasyVision Family WorkstationOption - 3D Volume Rendering	K953095
Image processingworkstation	Philips View Forum	K032096

Summary of Predicate Devices and 510(k) references Table 1:

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Invivo Corporation - DC Neuro Premarket Notification [510(k)] Submission

K081262
pg. 2 of 3

2. BASIS FOR SUBSTANTIAL EQUIVALENCE DETERMINATION 2.1. Device Description

2.1.1. Summary of device functions and the devices major components

2.1.2. Description of device (major components)

DC Neuro is a software package that uses standard PC hardware, with a standard uscr/operator interface (keyboard and mouse), and a standard Operating System: Microsoft Windows XP Professional.

2.2. Intended use

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K081262
pg. 3 of 3

BOLD fMRI: The BOLD analysis is useful in quantifying small susceptibility changes in the human brain, created by the execution of a specific task.

Dynamic Analysis: Dynamic analysis is intended for visualization and analysis of MR dynamic studics, showing changes in contrast over time, where such techniques are useful or necessary.

Vessel Analysis: Allows the visualization of vascular morphology from contrast-enhanced MR images.

3D Visualization: 3D rendering allows the visualization of bone, vascular structures, and selected anatomy as three dimensional object surfaces projected on a flat screen.

2.3. Safety Information

No new hazards are introduced by Invivo Corporation's DC Neuro, as compared to predicated devices and image processing functionality.

2.4. Conclusion

Invivo Corporation's DC Neuro is substantially equivalent to the Philips ViewForum 2003 workstation, and the Philips BOLD fMRI. Diffusion/Fiber Tracking, Dynamic and Vessel Analyses, and 3D visualization image processing functionality.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is simple and uses a monochrome color scheme.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2008

Invivo Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K081262

Trade/Device Name: DC Neuro Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 5, 2008 Received: June 6, 2008

Dear Mr. Job:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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	INDICATIONS FOR USE
own):	K081262

510(k) Number (if knov

Device Name:

DC Neuro

Indications For Use:

BOLD fMRI: The BOLD analysis is useful in quantifying small susceptibility changes in the human brain, created by the execution of a specific task.

Dynamic Analysis: Dynamic analysis is intended for visualization and analysis of MR dynamic studies, showing changes in contrast over time, where such techniques are useful or necessary.

Vessel Analysis: Allows the visualization of vascular morphology from MR images.

AND/OR

3D Visualization: 3D rendering allows the visualization of bone, vascular structures, and selected anatomy as three dimensional object surfaces projected on a flat screen.

Prescription Use J (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arjun Mr. Whang

ductive Abdominal, and 510(k) Numbe

Page 1 of 1

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).