PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION

K083555 · Emsoma Co., Ltd. · LLZ · Dec 16, 2008 · Radiology

Device Facts

• Record ID: K083555
• Device Name: PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION
• Applicant: Emsoma Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Dec 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

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 Story

PetaVision is a PACS software system for radiologists and physicians; enables electronic storage, retrieval, and viewing of medical images (CR, CT, MR). Inputs include DICOM-compliant images from various modalities; system manages image acquisition, database storage, and worklist management (patient ID, study details). Features include image manipulation, enhancement, compression, and quantification tools. Display modes include standard film-view simulation and Cine View for sequential image review (e.g., MRI/CT stacks). Radiologists use the interface to review images and generate/approve reports. System facilitates clinical decision-making by allowing rapid access and comparison of patient studies. Intended for clinical environments; not for mammography.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PACS software; DICOM protocol compliant; supports image acquisition, storage, and display; features include image manipulation, enhancement, compression, and quantification; Cine View mode for sequential image display; database-driven worklist management.

Indications for Use

Indicated for use by radiologists and physicians to store, view, and process medical images (CR, CT, MR, etc.) for diagnostic purposes. Not intended for mammographic applications.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• MEDIFACE PACS (K010259)

Submission Summary (Full Text)

{0}------------------------------------------------

## 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_

11:16 PM 10:25 11:29:01:01 1990:201 ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍ

19.11 11.

DEC 1 6 2008

1. Company and Correspondent making the submission:

8 23 11

Name - EMSOMA Co., Ltd.

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

030, Korea

Telephone - [phone]

Fax - [phone]

Contact - Mr. WeonBum, Lee

Internet - http://www.emsoma.com

- 2. 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) |

- 4. Classifications Names & Citations : e program ( 21CFR 892.2050, LLZ, Imaging Processing System, Radiological, Class2
5. Description :

#### 5.1 General

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

EMSOMA Co., Ltd.

## 00000018

20 800 (1981) - 1987-14) 3089 8 1 ් පිහිටා දින දින කරන දින දින කියෝ 1 - 2000 ද

{1}------------------------------------------------

#### 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.

- 2) 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

3) 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

新资讯 - 国际娱乐官网 2017

- Stiffannis

4) DICOM image display برب برابر ب . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Image display mode is most general one that simulate as if film is read at the film view box. Cine View Mode can show a senes of images, as seeing movie with a certain focused area fixed in a certain time interval for reading. Cine View Mode is very helpful in reading a series of images acquired from like MRI and CT modality.

indication for use : ട്

Contract Cases meterlan fresion a RAJA Profour

And The Sun State of School State of Children and Code

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

- 8. 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.

- 9. EMSOMA Co., Ltd. will update and include in this summary any information deemed seasonably necessary by the FDA. :

| END | | Children and Children Children Children Children |
|------------------|-----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| | | |
| | | 的一个人的人物,将为了用户。 上一篇: 我们的时候,在这个 |
| | | ி வாழிப்புகள்<br>1000 - 1000 - 1000 |
| | | ි පිහිටා ගෙන හිමි (March 1) |
| | | ート アイバー アドレス第14年 新記は『料理』に代表 |
| | | |
| | | ਾ ਅਤੇ ਇਸ ਦੀ ਇੱਕ ਸਾਰਕ ਦਾ ਸਾਲ ਕਾਰਕ ਕਾਰਕ ਕਾਰਕਾਰ ਦਾ ਸ<br>100 17 Supportunities Count in Collection Comes |
| | 1 11:50 1 | 11:40 【字号: 【字号: 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【<br>이 대한 사람들이 지원을 |
| | | |
| | | ,可以看到了我的意思想的人都得到明露。<br>: # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # |
| | | 11 10 14:10 10 10 11 12:00 12:00 11:00 11:00 11:00 11:00 11:00 11:00 11:00 11:00 11:00 11:00 11:00 11:00 11:00 11:00 11:00 11:00 11: |
| | | |
| EMSOMA Co., Ltd. | | 00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 |
| | | ക്കുന്നു. ഇവിടെ വിശ്വാസമുഖ്യ ചെയ്തു. പ |

{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.

{4}------------------------------------------------

### 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 [phone] or [phone] 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

{5}------------------------------------------------

## Indications for Use

成功能够被控制的体系的意见。

510(k) Number (if known):

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

Indications for Use:

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.

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)

1955 1982961 359

· 00000017

11 115 201

קיירה מקום מקום משואים במקום

125 - 1 - 2 - 2 - 2 - 1 - 1 - 1 - 1 - 1 - 1 -

11:20:00 : トェット (gr) 800mm 3.

ന്നതിനു പ്രസ്ത്രിച്ചിരിച്ചിരിക്കുന്നത്.

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

> Concurrence of CDRH, Office of Device Evaluation (ODE) 11 minde ・おなんでした