ImageQube is intended for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, MRI, NM, DR, US, nuclear medicine, Angio and secondary capture devices such as film digitizers or other imaging sources. The ImageQube Web system is designed for acquisition, storage, and distribution of all modalities. Device is also designed for primary interpretation of all modalities except manmography. Device is not to be used for primary imaging diagnosis in mammography and will be conspicuously labeled as such during display of mammography images. The acquired medical images and demographic information may be displayed, processed, reviewed optionally utilizing Rational Imaging PACS Multi-planar Reconstruction (MPR), Anatomic Triangulation (AT) and 3D display, sent to and retrieved by radiologists at remote sites, stored, archived or printed.

Device Description

ImageQube is designed for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, CR, MRI, NM, DR, US, Angio, nuclear medicine, and secondary capture devices such as film digitizers or other imaging sources.. The acquired medical images and demographic information may be displayed, processed, reviewed, sent to and retrieved by radiologists at remote sites, stored, archived or printed. Multi-planar Reconstruction (MPR). Anatomic Triangulation (AT) and 3D display are optionally available.

AI/ML Overview

The provided text describes the 510(k) summary for the ImageQube device, which is an Image Processing system (PACS). The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of its performance against specific acceptance criteria. Therefore, several of the requested sections cannot be fully populated from the provided document.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report device performance in terms of metrics like sensitivity, specificity, accuracy, or other benchmarked performance indicators. The comparison is feature-based against a predicate device.

Feature	Acceptance Criteria (Implied)	Reported ImageQube Performance
Multimedia Enterprise Distribution of images and data via Internet or Intranet	Equivalence to predicate	Y (Equivalent to Amicas Light Beam)
Automatically receive DICOM images from any Imaging Acquisition Device	Equivalence to predicate	Y (Equivalent to Amicas Light Beam)
Inter-vendor communication (Receive RIS from HL7 compliant systems)	Equivalence to predicate	Y (Equivalent to Amicas Light Beam)
DICOM compliance	Equivalence to predicate	Y (Equivalent to Amicas Light Beam)
IHE compliance	Equivalence to predicate	Y (Equivalent to Amicas Light Beam)
Image Server API	Functional API	IQViewer (Equivalent to LightView)
Secure Web Based Administration	Equivalence to predicate	Y (Equivalent to Amicas Light Beam)
Maximum Intensity Projection (MIP)	Not present in ImageQube	N (Predicate has it)
Cross Sectional Viewing	Equivalence to predicate	Y (Equivalent to Amicas Light Beam)
Plain Film Studies	Equivalence to predicate	Y (Equivalent to Amicas Light Beam)
Individual User Templates	Equivalence to predicate	Y (Equivalent to Amicas Light Beam)
Image review and manipulation tools	Equivalence to predicate	Y (Equivalent to Amicas Light Beam)
Image Measurement tools	Equivalence to predicate	Y (Equivalent to Amicas Light Beam)
Transmission	Functional transmission	Lurawave® (Predicate uses JPEG2000)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document describes a feature-based comparison for substantial equivalence, not a performance study using a test set of medical images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The document describes a PACS system, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The ImageQube is a PACS system for image management and display; it's not a standalone diagnostic algorithm. The "standalone" performance in this context would refer to its ability to perform its core functions (acquire, process, archive, distribute images) which is implicitly covered by the "Substantial Equivalence" claim.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth is established as this is a comparison of technical features and functionality of a PACS system.

8. The sample size for the training set

Not applicable. The device is a PACS system that processes and displays images; it is not an AI/ML model that requires a training set in the conventional sense.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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JUN 2 8 2005

510(k) Summary of Safety and Effectiveness

Per Title 21 CFR 807 . 92, the following is the 510(k) Summary for the ImageQube manufactured and marketed by Intuitive Imaging Informatics, LLC under the trade-name

(1)	SUBMITTER:	Intuitive Imaging Informatics, LLC30 Hackamore Lane Suite 4Bell Canyon, CA 91307-1061818-347-8919 (phone)818-347-8909 (fax)
	CONTACT:	Donald MundtManager, Regulatory AffairsIntuitive Imaging Informatics, LLC30 Hackamore Lane Suite 4Bell Canyon, CA 91307-1061818-347-8919 (phone)818-347-8909 (fax)
	SUBMISSION DATE:	15 January 2005
(2)	DEVICE NAME:
	TRADE NAME:	ImageQube
	COMMON NAME:	Image Processing system
	CLASSIFICATION NAME:	(per regulation 21 CFR 892.2050) (Class II device)Picture Archiving and Communication System (PACS)
	PRODUCT CODE:	LLZ

(3) PREDICATE DEVICE:

Intuitive Imaging Informatics claims Substantial Equivalence to the following device:

Manufacturer	Trade Name	510(k) Number	Decision Date
Amicas Inc.	Amicas Light BeamWorkstation	K022970	11-22-02

(4) DEVICE DESCRIPTION:

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digitizers or other imaging sources.. The acquired medical images and demographic information may be displayed, processed, reviewed, sent to and retrieved by radiologists at remote sites, stored, archived or printed. Multi-planar Reconstruction (MPR). Anatomic Triangulation (AT) and 3D display are optionally available.

(ર) INTENDED USE OF DEVICE

The ImageQube PACS is intended for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, MRI, NM, DR, US, nuclear medicine, Angio and secondary capture devices such as film digitizers or other imaging sources. The acquired medical images and demographic information may be displayed, processed, reviewed optionally utilizing Multi-planar Reconstruction (MPR), Anatomic Triangulation (AT) and 3D display, sent to and retrieved by radiologists at remote sites, stored, archived or printed.

(6) SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE

The proposed ImageQube, with MPR, AT options, and the predicate device Light Beam are both software suites that process DICOM compliant images and provide a standard set of features pertaining to image processing, archiving and networking. The image manipulation tools and storage techniques are essentially comparable. Workstations are technologically the same with some differences in media type for archival storage. Compression algorithms are different but accomplish the same results. Both products operate on commercially available equipment and are available as either a hardware/software package or software only.

Feature	I3ImageQube	AmicasLight BeamWorkstation
Multimedia Enterprise Distribution of images and data viaInternet or Intranet	Y	Y
Automatically receive DICOM images from any ImagingAcquisition Device	Y	Y
Inter-vendor communication
Receive RIS from HL7 compliant systems	Y	Y
DICOM	Y	Y
IHE	Y	Y
Image Server API	IQViewer	LightView
Secure Web Based Administration	Y	Y
Maximum Intensity Projection (MIP)	N	Y
Cross Sectional Viewing	Y	Y
Plain Film Studies	Y	Y
Individual User Templates	Y	Y
Image review and manipulation tools	Y	Y
Image Measurement tools	Y	Y
Transmission	Lurawave®	JPEG2000

(7) SAFETY

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The potential hazards are identified and controlled by a risk management plan. The plan consists of a risk management summary, a software development and validation process, a software verification plan and conformance to Federal Regulations and Industry Standards.

(8) CONCLUSION

The ImageQube DICOM compliant imaging system acquires, processes, archives and distributes images over the Internet utilizing similar techniques and functions as the predicate device Amicas Light Beam Workstation.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Intuitive Imaging Informatics, LLC % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Medical Device Services Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169

Re: K051037 Trade/Device Name: Intuitive Imaging Informatics ImageQube Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 14, 2005 Received: June 15, 2005

Dear Mr. Christensen:

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 (Premarket Approval), 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.

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.

JUN 2 8 2005

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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 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 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

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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510(k) Number (if known): _ K051037_

Device Name: Intuitive Imaging Informatics ImageQube

Indications for Use

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Stan-Off), Division of Reproductive, Abe and Radiological Devices 510(k) Number

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).