(14 days)
No
The summary describes a standard PACS system with image processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is a Picture Archiving and Communication System (PACS) software designed for viewing, storing, and processing medical images, but it does not directly treat or diagnose patients.
No
The PetaVision is described as PACS (Picture Archiving and Communication System) software that stores, transfers, displays, and processes medical images without performing any diagnostic analysis or interpretation. Its purpose is to manage image data rather than to diagnose conditions.
Yes
The device description explicitly states "PetaVision™ is PACS (Picture Archiving and Communication System) software" and focuses solely on the software's capabilities for image handling and processing, without mentioning any associated hardware components included as part of the device.
Based on the provided information, the PetaVision device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- PetaVision's Function: The description clearly states that PetaVision is a PACS (Picture Archiving and Communication System) software. Its primary functions are related to the management and display of medical images acquired from imaging devices like CR, CT, and MR. It handles the acceptance, transfer, display, storage, and digital processing of these images.
- No Specimen Analysis: There is no mention of PetaVision being used to analyze biological specimens or providing diagnostic information based on such analysis. Its input is medical images, not biological samples.
Therefore, PetaVision falls under the category of medical imaging software or a PACS system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 may 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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:
The main functions of Peta Vision 114 are as follows.
- 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. - 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. - 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. - DICOM image display
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, CT, MR and other devices
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radlologist and physician doctor
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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_
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19.11 11.
DEC 1 6 2008
- 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 - +82-2-3462-2008
Fax - +82-2-3462-2088
Contact - Mr. WeonBum, Lee
Internet - http://www.emsoma.com
-
- 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) |
-
- 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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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
-
- 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.
- Image Acquisition
-
- 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
- Worklist
- 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
-
- 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.
- Conclusions :
-
- EMSOMA Co., Ltd. will update and include in this summary any information deemed seasonably necessary by the FDA. :
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| 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 (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
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
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