ZIOSTATION is an image processing workstation software package designed to run on standard PC hardware. The required hardware consists of standard 'off-the-shelf' computer components. It receives image data from standard modalities (medical image scanning devices) or from image archives. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It can be used as a just a workstation or as a client-server within a network. It is intended for use by trained medical imaging professionals to aid in their reading and review of such data.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammograpic images may only be interpreted using an FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Description

ZIOSTATION is a software-only imaging workstation that installs on one or more of a customer's standard PCs and integrates with a customer's 'off the shelf' PC-based computer components to provide viewing, quantification, manipulation, communication, printing, and management capabilities for medical images. It provides access to both local and centralized (networked) image data.

ZIOSTATION can acquire and work with image data from multiple DICOM-compliant modalities and image archives. It provides querying and listing based on user-selected criteria. It provides for multiple types of 2D and 3D image displays. It provides interactive menus and tools for image manipulation and measurement. ZIOSTATION provides workflow enhancement and optional specialist tools for clinical applications.

ZIOSTATION uses only lossless compression for images used for diagnostic purposes. It does use lossy compression when exporting to JPEG and AVI files, but its labeling indicates that those files are not to be used for clinical evaluations.

AI/ML Overview

The ZIOSTATION is a PACS system that has not conducted any clinical studies to establish specific acceptance criteria or performance metrics directly from the provided text. The document states that the device has been "thoroughly tested by Ziosoft in accordance with their software development and validation procedures" and "independently evaluated by trained physicians specializing in medical imaging disciplines." However, no specific acceptance criteria or performance data from these evaluations are presented in the document.

Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device, the Barco Voxar 3D Enterprise (K061326). The "acceptance criteria" in this context are implicitly met by showing that ZIOSTATION's features and intended use are essentially identical to the predicate device, and that it does not introduce any new safety or efficacy concerns.

Given the information in the provided text, the specific details requested for a study proving device adherence to acceptance criteria (such as sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not available. The document focuses on regulatory clearance through substantial equivalence rather than explicit performance evaluation against predefined numerical criteria.

Therefore, the table of acceptance criteria and reported device performance cannot be filled with numerical values, and many of the questions regarding study design cannot be answered from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, no specific numerical acceptance criteria or performance metrics are reported for ZIOSTATION. The submission relies on substantial equivalence to a predicate device.

Acceptance Criteria (Not Explicitly Stated - Inferred from Equivalence Claim)	Reported Device Performance (Not Explicitly Stated - Inferred from Equivalence Claim)
Functional Equivalence: Must perform core image processing and management functions similarly to the predicate device.	ZIOSTATION provides identical basic functions (view, quantify, manipulate, communicate, print, and manage medical images) as the predicate device (Voxar 3D Enterprise).
Technical Equivalence: Must be compatible with standard hardware, DICOM compliant, and offer comparable imaging capabilities (2D, 3D, measurement, segmentation, remote rendering).	ZIOSTATION is compatible with PC/Windows OS, DICOM 3.0, acquires data from multiple sources, offers 2D/3D imaging, measurement tools, segmentation tools, and remote rendering, all "same" as the predicate.
Clinical Application Equivalence: Must provide comparable optional specialist tools and workflow enhancements for clinical applications.	ZIOSTATION offers "optional specialist tools and workflow enhancements for clinical applications such as coronary, colon, and vessel analysis," which are "same" as the predicate.
Intended Use Equivalence: Must have the same intended use by trained medical imaging professionals.	ZIOSTATION is "intended for use by trained medical imaging professionals to aid in their reading and review of such data," which is "same" as the predicate.
Safety and Efficacy: Must not raise new safety or efficacy concerns compared to the predicate.	Ziosoft "demonstrated that ZIOSTATION is safe and effective for its intended use" and "does not raise any new safety or efficacy concerns."
Interpretation Restrictions: Must adhere to specific restrictions for mammographic image interpretation.	"Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by FDA." (This is a condition of use rather than a performance metric.)

2. Sample size used for the test set and the data provenance

Not specified. The document mentions internal testing and independent evaluation by physicians but provides no details on sample size or data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified. The document vaguely states "independently evaluated by trained physicians specializing in medical imaging disciplines" but does not quantify the number of experts or their specific qualifications (e.g., years of experience, subspecialty). No explicit "ground truth" establishment process for a test set is described.

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

Not specified. No details on adjudication methods for any evaluation are provided.

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

No indication of an MRMC study. The ZIOSTATION is an image processing workstation, not specifically an AI-driven diagnostic aid that would typically undergo such a study to measure reader improvement. The document does not describe AI functionality or a reader improvement study.

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

Not applicable/Not specified as a standalone algorithm. ZIOSTATION is described as an "image processing workstation software package" intended for use by "trained medical imaging professionals to aid in their reading and review." It is not presented as a standalone diagnostic algorithm.

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

Not specified. Since no specific performance study with a test set is detailed, the type of ground truth used is not mentioned. The primary argument is substantial equivalence to a predicate, not performance against a ground truth dataset.

8. The sample size for the training set

Not applicable/Not specified. ZIOSTATION is an image processing and visualization system, not an AI/machine learning model where a distinct "training set" would typically be referenced for model development. The document does not mention any machine learning components requiring a training set.

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

Not applicable/Not specified. As there's no mention of a training set, the method of establishing ground truth for it is also not discussed.

Summary

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1070205

1. 510(K) SUMMARY - BASIC INFORMATION

This 510(k) Summary is prepared in accordance with 21 CFR 807.92.

1.1 SUBMITTER

MAR 2 3 2007

Applicant:	Ziosoft, Inc.7th Floor, TTD Building1-2-18 Mita, Minato-kuTokyo, 108-0073 Japan
Contact:	Marc Goodman, Noblitt & R
ﺎﺕ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ	Marc Goodman, Noonti & Rueland
	5405 Alton Parkway, Suite A530
	Irvine, CA 92604
	USA

Date Prepared: January 18, 2007

1.2 DEVICE NAME

Device Name:	ZIOSTATION
Common Name:	Image processing, management and visualization system
Classification Name:	System, Image Processing, Radiological

1.3 IDENTIFICATION OF LEGALLY MARKETED DEVICE

Substantial equivalence is claimed to the Barco Voxar 3D Enterprise (K061326).

1.4 DEVICE DESCRIPTION

1.5 INTENDED USE

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used as a just a workstation or as a client-server within a network. It is intended for use by trained medical imaging professionals to aid in their reading and review of such data.

1.6 COMPARISON TO CLEARED DEVICE

Table 1 provides a tabular comparison of ZIOSTATION features with those of the legally marketed devices identified in 1.3 above.

Feature	ZIOSTATION	Voxar 3D Enterprise (K061326)
Basic Function	View, quantify, manipulate, communicate, print, and manage medical images	same
Computer Platform	PC with Windows OS	same
DICOM compliance	DICOM 3.0	same
Data Acquisition	Can acquire medical image data from multiple sources including DICOM files (from image archives) and multiple DICOM-compliant modalities.	same
2D Imaging	2D image viewer with interactive controls	same
3D Imaging	3D image rendering with interactive controls	same
Measurement Tools	yes	yes
Segmentation Tools	yes	yes
Remote Rendering	yes	yes
Clinical Applications	Provides (optional) specialist tools and workflow enhancements for clinical applications such as coronary, colon, and vessel analysis.	same
Prescription Use	yes	same
Intended Users	trained professionals	same

Table 1: Comparison of ZIOSTATION to SE Devices

2. PERFORMANCE INFORMATION

ZIOSTATION has been thoroughly tested by Ziosoft in accordance with their software development and validation procedures, and it has been independently evaluated by trained physicians specializing in medical imaging disciplines.

3. CONCLUSION

Ziosoft has demonstrated that ZIOSTATION is safe and effective for its intended use. A comparison with legally marketed devices indicates that it is substantially equivalent to those devices, and that it does not raise any new safety or efficacy concerns.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or a caduceus-like design, with flowing lines representing movement or connection.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ziosoft, Inc. c/o Mr. Marc Goodman Senior Associate Noblitt and Rueland 5405 Alton Parkway, Suite A530 IRVINE CA 92604

MAR 2 3 2007

Re: K070205

Trade/Device Name: ZIOSTATION Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 18, 2007 Received: January 22, 2007

Dear Mr. Goodman:

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.

Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006 FDA Centennial" in the center. The letters "FDA" are large and bolded. There are three stars below the word "Centennial". The logo is surrounded by a ring of text and stars.

Protecting and Promoting Public Health

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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 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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K070205

Indications for Use Statement

ZIOSTATION is an image processing workstation software package designed to run on standard PC hardware. The required hardware consists of standard `off-the-shelf' computer components. It receives image data from standard modalities (medical image scanning devices) or from image archives. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It can be used as a just a workstation or as a client-server within a network. It is intended for use by trained medical imaging professionals to aid in their reading and review of such data.

Lossy compressed mammographic imaqes and diqitized film screen images must not be reviewed for primary image interpretations. Mammograpic images may only be interpreted using an FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by FDA.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE TO ANOTHER PAGE IF NEEDED

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use		OR	Over-The-Counter Use
(Per 21 CFR 801.109)
	(Division Sign-Off)
	Division of Reproductive, Abdominal,
	and Radiological Devices
510(k) Number	K070205

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).