The PetaVision is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to Image manipulation, enhancement, compression or quantification. And Images may be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic applications.

Device Description

PetaVision™ is PACS (Picture Archiving and Communication System) software for radlologist and physician doctor. By use of PetaVision™ enables images such as xray and scans to be stored electronically and viewed on screens. Doctors and other health professional can access and compare images at the touch of a button Also, PetaVision™ is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to image manipulation, enhancement, compression or quantification. And Images may be acquired from imaging devices such as CR, CT, MR and other devices.

AI/ML Overview

The provided text is a 510(k) summary for the PetaVision PACS device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not available in this document.

Here's an analysis of the provided information concerning the acceptance criteria and study, with clear indication of what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not provided. This document highlights functional equivalence to a predicate PACS system, not specific quantitative performance criteria. It mentions capabilities like image acquisition, worklist management, reading/reporting, and DICOM image display.	Not provided. The document states that the PetaVision performs functions related to image manipulation, enhancement, compression, or quantification, but no performance metrics (e.g., accuracy, speed, robustness) are given. It implies the performance is "substantially equivalent" to the predicate device.

Missing Information: Specific, measurable acceptance criteria (e.g., image display accuracy, processing speed, data transfer rates, system uptime, error rates). Quantitative performance results against such criteria.

2. Sample Size Used for the Test Set and Data Provenance

Not provided. The document does not describe any specific test set of medical images or patient data used for evaluating the PetaVision device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable/Not provided. Since no specific test set or clinical evaluation is described, there's no mention of experts establishing ground truth for such a test. The device is a Picture Archiving and Communication System (PACS) and its primary function is display and management, not diagnostic interpretation in itself.

4. Adjudication Method for the Test Set

Not applicable/Not provided. As no test set is detailed, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This document does not describe an MRMC comparative effectiveness study. PACS systems typically do not undergo MRMC studies in the same way diagnostic AI algorithms do, as their primary function is infrastructure (display, storage, transfer) rather than direct diagnostic interpretation assistance. The efficacy claim is based on substantial equivalence to an existing PACS.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, implicitly. The device itself, PetaVision, is a standalone software system. Its function is to perform operations related to image manipulation, enhancement, compression, transfer, display, and storage without direct human intervention in the execution of these underlying software functions. However, its overall utility is in supporting human radiologists and physicians. No performance study of the algorithm in isolation (e.g., measuring its success rate in image acquisition or display) is detailed in this summary. Instead, the focus is on the functions it provides.

7. The Type of Ground Truth Used

Not applicable/Not provided. As no specific evaluation of diagnostic performance against objective ground truth (e.g., pathology, outcomes data) is presented, the concept of "ground truth" as it pertains to diagnostic accuracy is not relevant here. The device's "ground truth" would be its ability to correctly perform its stated functions (e.g., display an image accurately as originally acquired), but this is not explicitly detailed as a ground truth in the context of a performance study in this summary.

8. The Sample Size for the Training Set

Not applicable/Not provided. PetaVision is described as a Picture Archiving and Communication System (PACS) software. It is not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns or making diagnostic predictions. Its functionality is based on established DICOM standards and imaging processing techniques.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided. As stated above, this device is not an AI/ML algorithm requiring a training set with established ground truth.

Summary of Device and Study as Per Provided Text:

The PetaVision is a Picture Archiving and Communication System (PACS) software designed to acquire, transfer, display, store, and digitally process medical images from various modalities (CR, CT, MR, etc.). It facilitates image manipulation, enhancement, compression, and quantification. It is not intended for mammographic applications.

The study described here is a 510(k) premarket notification aiming to demonstrate substantial equivalence to a predicate device, the MEDIFACE PACS (K010259). The document concludes that PetaVision is safe and effective and substantially equivalent to the predicate device based on the information provided in the premarket notification. This type of submission relies on comparing design, indications for use, technological characteristics, and performance data (if available) to an already cleared device, rather than conducting a de novo clinical performance study against specific acceptance criteria.

The submission does not provide details on specific performance metrics, sample sizes for test sets, data provenance, expert qualifications for ground truth, adjudication methods, or results of MRMC or standalone performance studies against defined acceptance criteria. It primarily focuses on defining the device's functions and claiming equivalence to a predicate PACS system.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: Nov. 5, 2008_

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19.11 11.

DEC 1 6 2008

Company and Correspondent making the submission:

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Name - EMSOMA Co., Ltd.

Address - #302 Kang-rim B/D, Sungnae-dong 448-7, Gangdong-gu, Sebul, 134-

030, Korea

Telephone - +82-2-3462-2008

Fax - +82-2-3462-2088

Contact - Mr. WeonBum, Lee

Internet - http://www.emsoma.com

1. Device :

Trade/proprietary name	: PetaVision
Common Name	: Picture archiving and communication system(PACS)
Classification Name	: Imaging Processing System, Radiological

3. Predicate Device :

Manufacturer	: Mediface Co., Ltd.
Device	: MEDIFACE PACS
510(k) Number	: K010259(Decision Date - Jan. 29. 2001)

1. Classifications Names & Citations : e program ( 21CFR 892.2050, LLZ, Imaging Processing System, Radiological, Class2

Description :

5.1 General

PetaVision™ is PACS (Picture Archiving and Communication System) software for

EMSOMA Co., Ltd.

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510(k) Submission - PetaVision

radlologist and physician doctor. By use of PetaVision™ enables images such as xray and scans to be stored electronically and viewed on screens. Doctors and other health professional can access and compare images at the touch of a button Also, PetaVision™ is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to image manipulation, enhancement, compression or quantification. And Images may be acquired from imaging devices such as CR, CT, MR and other devices:

The main functions of Peta Vision 114 are as follows.

5.2 Main Function

1. Image Acquisition
  It acquires DICOM Image that is transmitted in the form of DICOM Protocol from each of various modalities and loads such data, corresponding to that image, into Database.
1. Worklist
  Worklist contain patients name, sex, patients ID, Study date, Study description, concerned clinic department, name of doctor, reading results and thumbnail image. It shall be available at user's sort out, adjust the size of columns. 11:40

Reading

Report makes It possible to make a report more easily by using intuitive user interface. Radiology doctor has the right to approve or to modify the report before approved. 11 498 580 1 88 11 1 88 111 104

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The PetaVision is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. And Images may

EMSOMA Co., Ltd.

{2}------------------------------------------------

510(k) Submission - PetaVision

be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic applications.

б Comparison with predicate device :

EMSOMA Co., Ltd., believes that the Picture archiving and communication system(PetaVision) is substantially equivalent to the MEDIFACE PACS of Mediface Co., Ltd.. A Andrew a

1. Conclusions :
  In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 based on the information provided in this premarket notification EMSOMA Co concludes that The PetaVision is safe and effective and substantially equivalent to predicate devices as described herein.
1. EMSOMA Co., Ltd. will update and include in this summary any information deemed seasonably necessary by the FDA. :

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{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 2008

EMSOMA Co., Ltd. % Mr. Marc M. Mouser CAS Manager II/Office Coordinator Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607

Re: K083555

Trade/Device Name: Picture archiving and communication system (PACS)/ Peta Vision Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ

Dated: November 6, 2008

Received: December 2, 2008

Dear Mr. Mouser:

We have reviewed vour 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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/cdrh/industry/support/index.html.

Sincerely vours.

hoque Inthang

Joyce M. Whang, Ph.D. Acting 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

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510(k) Number (if known):

Device Name: Picture archiving and communication system (PACS) Peta Vision

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

(Division Sign-Off)

Radiological Devices 510(k) Number

Division of Reproductive, Abdominal and

AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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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).