ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT

K120995 · Erad, Inc. · LLZ · Dec 3, 2012 · Radiology

Device Facts

• Record ID: K120995
• Device Name: ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT
• Applicant: Erad, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

eRAD PACS/ eRAD RIS/PACS is a PACS software product used to receive DICOM images, scheduling information and textual report, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. The eRAD PACS/ eRAD RIS/PACS viewer software is intended for use as a primary diagnostic and analysis tool for diagnostic images. eRAD PACS/ eRAD RIS/PACS is for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. The eRAD PACS/ eRAD RIS/PACS viewer displays images from CT, computed radiography, MRI, mammography, nuclear medicine, PET, secondary capture, ultrasound, x-ray angiography, x-ray fluoroscopy and visible light modalities. Lossy compressed mammography images and digitized film screen mammography images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega-pixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Story

eRAD PACS/RIS is a software-based Picture Archiving and Communication System. It receives DICOM images, scheduling data, and reports; organizes and stores them; and distributes them across networks via web/customized interfaces. Components include acquisition modules, a central systems manager, diagnostic viewers, and archiving storage. The system retrieves prior studies, registers images, and manages worklists. Radiologists use diagnostic workstations to view images and dictate reports; the system supports playback and transcription. Reports are then accessible to referring physicians or exported to other information systems. The device is used in clinical settings (hospitals, imaging centers) by radiologists and authorized personnel. It facilitates clinical decision-making by providing centralized access to patient imaging and diagnostic reports, improving workflow efficiency and diagnostic capability.

Clinical Evidence

Bench testing only. System verification and validation testing were conducted in accordance with international standards and internal design requirements to confirm performance and substantial equivalence to the predicate device.

Technological Characteristics

Software-only PACS system. Supports DICOM standard for image acquisition and communication. Web-based and customized user interfaces for image viewing and report management. Compatible with various imaging modalities (CT, MRI, PET, etc.). Requires FDA-approved 5MP monitors for primary mammography interpretation. Operates as a networked system for image/data storage and retrieval.

Indications for Use

Indicated for use by hospitals, imaging centers, radiologists, and reading practices as a primary diagnostic and analysis tool for viewing and managing medical images (CT, CR, MRI, mammography, nuclear medicine, PET, ultrasound, angiography, fluoroscopy, visible light). Contraindicated for primary interpretation of lossy compressed or digitized film-screen mammography images.

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

• eRAD PACS (K061421)

Submission Summary (Full Text)

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K120995

Image /page/0/Picture/1 description: The image shows a logo for "CeRAD". The logo features a stylized lowercase "e" with curved lines extending from the top and bottom, resembling a crescent shape. To the right of the "e" is the word "RAD" in bold, uppercase letters, with a trademark symbol next to it. The overall design is simple and modern, with a focus on the company's name.

# 510(k) Summary

eRAD, Inc.

C 0 3 2012

### Submitter:

Section 5:

9 Pilgrim Road Greenville, SC 29607

# Contact Person:

Jim Connors Vice President, Product Management eRAD, Inc. O: 864-640-8664 F: 864-234-7412

# Official Correspondent:

Jillian M. Reed Regulatory and Clinical Affairs Consultant Reed Technical Associates, LLC 23 Griswold Lane Winsted, CT 06098 O: 860-238-7734 F: 203-538-3960 [e-mail]

| Date Prepared: | October 5, 2012 |
|----------------------|----------------------------------------|
| Classification Name: | System, Image Processing, Radiological |
| Common Name: | PACS |
| Proprietary Name: | eRAD PACS and eRAD RIS/PACS |
| Predicate Devices: | eRAD PACS- #K061421(July 25, 2006) |

# Device Description:

eRAD PACS/ eRAD RIS/PACS Software Product is a PACS system, comprised of acquisition components, a central systems manager component, diagnostic viewing components, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. After receiving the procedure information or after receiving image objects, the central system manager searches for and retrieves relevant prior procedure data from the archiving a component. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the item from the operator worklist. The image data is

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Image /page/1/Picture/0 description: The image shows the logo for eRAD, a medical imaging software company. The logo features a stylized lowercase "e" with three curved lines emanating from it, resembling radio waves. To the right of the "e" is the word "RAD" in bold, sans-serif font. The logo is simple, modern, and easily recognizable.

transmitted to and rendered on the user's workstation using the diagnostic viewing components. After using the workstation to view the images, the user optionally dictates a report into the system, after which, a user can play back the diction and transcribe it to text. Once eRAD PACS's central system manager registers a report, the report is available for access by the referring physician, or it can be exported into an information system. At some configured point in time, the image data and the report information is delivered to the archiving component for backup and long-term storage.

### Intended Use: . .

eRAD PACS/ eRAD RIS/PACS is a PACS software product used to receive DICOM images, scheduling information and textual report, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces.

The eRAD PACS/ eRAD RIS/PACS viewer software is intended for use as a primary diagnostic and analysis tool for diagnostic images. eRAD PACS/ eRAD RIS/PACS is for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.

The eRAD PACS/ eRAD RIS/PACS viewer displays images from CT, computed radiography, MRI, mammography, nuclear medicine, PET, secondary capture, ultrasound, x-ray angiography, x-ray fluoroscopy and visible light modalities.

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

#### Substantial Equivalence:

The modifications to the eRAD PACS/ eRAD RIS/PACS Software do not alter the fundamental scientific technology of the device. The only modification made to the predicate device is making the software available to the user in a software-only option.

# Discussion of Non-Clinical Testing Performed:

Thorough non-clinical system verification and validation testing was conducted in accordance with applicable international standards and internal design requirement to verify that the eRAD PACS/ eRAD RIS/PACS Software Product meet user needs and indications for use. Testing demonstrated that the eRAD PACS/ eRAD RIS/PACS Software Product were substantial equivalent to their predicate devices.

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Image /page/2/Picture/0 description: The image shows a logo with the letters 'eRAD' in a stylized font. The 'e' is formed by three curved lines that resemble a stylized letter 'C' facing right. The 'RAD' is in bold, sans-serif font, with a small circle containing a registered trademark symbol to the right of the 'D'. The overall design is simple and modern.

# Conclusions:

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The information provided in this premarket notification submission has shown that the eRAD PACS/ eRAD RIS/PACS Software Product is substantially equivalent to the predicate devices and are safe and effective for its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

eRAD, Inc. % Ms. Jillian M Reed Regulatory and Clinical Affairs Consultant Reed Technical Associates, LLC 23 Griswold Lane WINSTED CT 06098

December 3, 2012

Re: K120995

Trade/Device Name: eRAD PACS/eRAD RIS/PACS Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 8, 2012 Received: October 9, 2012

Dear Ms. Reed:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2-Ms. Reed

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara

Janine M. Morris. M.S. Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): #K120995

Device Name: eRAD PACS/ eRAD RIS/PACS Software

Indications for Use:

eRAD PACS/ eRAD RIS/PACS is a PACS software product used to receive DICOM images, scheduling information and textual report, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces.

The eRAD PACS/ eRAD RIS/PACS viewer software is intended for use as a primary diagnostic and analysis tool for diagnostic images. eRAD PACS/ eRAD RIS/PACS is for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.

The eRAD PACS/ eRAD RIS/PACS viewer displays images from CT, computed radiography, MRI, mammography, nuclear medicine, PET, secondary capture, ultrasound, x-ray angiography, x-ray fluoroscopy and visible light modalities.

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

Prescription Use XX (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 in-vitro Diagnostics and Radiological Health (OIR)

Michael D'Okon

(Division Sign Off)

Division of Radiological Health

Ollice of In Vitro Diagnostics and Radiological Health

K120995

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