EDGE PACS

K081752 · Ashva Technologies, Pvt., Ltd. · LLZ · Aug 6, 2008 · Radiology

Device Facts

• Record ID: K081752
• Device Name: EDGE PACS
• Applicant: Ashva Technologies, Pvt., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 6, 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

Edge PACS™ is a software device (server, web viewer, & workstation) used for diagnostic viewing and manipulating medical images. Digital images and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. Edge PACS™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) providing access to reports for fully-integrated electronic patient records. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. 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.

Device Story

Edge PACS is a software-based Picture Archiving and Communication System (PACS) comprising a server, web viewer, and workstation. It ingests digital medical images from diverse sources (CT, MR, US, RF, CR/DR, scanners). The system enables diagnostic viewing, image manipulation (cropping, cine loop editing), storage, and network communication. It integrates with HIS/RIS for electronic patient records. Used in clinical settings by healthcare professionals to retrieve, compare images across visits, and generate reports for patient distribution (CD/email). The device facilitates clinical decision-making by providing centralized access to patient imaging history and statistical data. It does not contact patients or control life-sustaining equipment; human intervention is required for all interpretations.

Clinical Evidence

No clinical data provided. The submission relies on bench testing and verification of software functionality to demonstrate substantial equivalence.

Technological Characteristics

Software-only device; no patient-contacting components. Operates on standard computer hardware (server, workstation, web viewer). Supports DICOM-compatible imaging modalities. Features include image manipulation tools (cropping, cine loop editing), HIS/RIS integration, and secure patient record management. Does not control life-sustaining equipment. No specific algorithm architecture or hardware specifications provided.

Indications for Use

Indicated for diagnostic viewing and manipulation of medical images by clinicians. Supports various imaging modalities (CT, MR, US, RF, CR/DR). Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images. Mammography requires FDA-approved 5 Mpixel monitors.

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

• Voyager PACS System (K062062)

Submission Summary (Full Text)

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K081)52

# 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

April 21, 2008

Submitter's Information: 21 CFR 807.92(a)(1) Mr. Sunder Natrajan, CEO Ashva Technologies Pvt. Ltd., 15 ARK Colony, Urnilla House Eldams RD. Alwarpet. Chennai India 600018 91 44 420 88876 Tel: [phone] Fax:

AUG - 6 2008

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

| Trade Name: | Edge PACS™ |
|------------------------|-----------------------------------------|
| Common Name: | Picture Archiving Communications System |
| Classification Name: | system, image processing, radiological |
| Product code: | LLZ |
| Device Classification: | 892.2050 |

Predicate Device: 21 CFR 807. 92(a)(3)

| Edge PACS™ is substantially equivalent to: | |
|--------------------------------------------|----------------------------------------|
| Manufacturer: | Voyager Imaging |
| Device Name: | Voyager PACS System |
| 510(k) Number: | K062062 |
| Product Code: | LLZ |
| Device Classification Name: | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
| Regulation Number: | Class II - 892.2050 |

# Device Description: 21 CFR 807 92(a)(4)

Edge PACS, is a software device that consists of the Radion Workstation, Edge PACS Web Viewer, and Edge PACS Server and can be used for diagnostic viewing and manipulating of medical images. Digital images (including mammography and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. Edge PACS™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) providing access to reports for fully-integrated electronic patient records.

Edge PACS allows medical imaging centers to easily record patient details with study information along with their images and to prepare reports that can be distributed to the patient either in paper printout or through the Internet (email).

Moreover, it allows the user to retrieve images easily and to compare the images of the patient between different visits or to distribute the patient records in CD's. It also allows generating statistical data from the available details. Overall features include:

- . Prevent unauthorized access of Patient Records
- . Easy search of Patient details

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- Flexibility to design auto patient ID .
- Report transmission by mail .
- . Cropping of live images
- Editing of AVI/cine loops .
- . Distribution of Reports and Images in CD
- . Comparison of images between different visits of patient
- Tagging of significant images/cineloop for future references .
- Generation of statistical data from available details .

# Indications for Use: 21 CFR 807 92(a)(5)

Edge PACS™ is a software device (server, web viewer, & workstation) used for diagnostic viewing and manipulating medical images. Digital images and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software.

Edge PACS™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) providing access to reports for fullyintegrated electronic patient records.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. 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.

### Technological Characteristics: 21 CFR 807 92(a)(6)

Edge PACS™ is a software device that does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

# Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for Edge PACS™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ashva Technologies, Pvt., Ltd. % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

AUG - 6. 2008

Re: K081752

Trade/Device Name: Edge PACSTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 23, 2008 Received: July 24, 2008

Dear Mr. Devine:

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 (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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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 Center for Devices and Radiological Health's (CDRH's) 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 Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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/cdrb/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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## (Indications for Use Form)

1008 1752 510(k) Number:

Device Name:

Edge PACS™

Indications for Use:

Edge PACS™ is a software device (server, web viewer, & workstation) used for diagnostic viewing and manipulating medical images. Digital images and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software.

Edge PACS™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) providing access to reports for fully-integrated electronic patient records.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. 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.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Heula Penne

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number