EZPACS, VERSION 3.0

K062878 · Advanced Imaging Solutions, LLC · LLZ · Jun 27, 2007 · Radiology

Device Facts

• Record ID: K062878
• Device Name: EZPACS, VERSION 3.0
• Applicant: Advanced Imaging Solutions, LLC
• Product Code: LLZ · Radiology
• Decision Date: Jun 27, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

EZPACS® is intended for use by radiologists (for primary diagnosis), and other medical professionals who needs access to radiological images and reports. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. 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

EZPACS is a Picture Archiving and Communications System (PACS) software operating on off-the-shelf PCs and monitors running Microsoft Windows. It functions as a diagnostic workstation for radiologists and medical professionals. The system ingests medical images, providing tools for display, manipulation, enhancement, compression, and quantification. Key features include window/level adjustment, magnification, panning, annotation, measurement tools (ROI, distance, angle), cine/stack viewing, and 3D visualization. It supports DICOM standards and teleradiology workflows. By enabling efficient image review and analysis, the device assists clinicians in primary diagnosis and clinical decision-making, potentially improving diagnostic accuracy and patient care workflows.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and functional comparison to predicate devices.

Technological Characteristics

Software-based PACS running on off-the-shelf PCs and monitors with Microsoft Windows OS. Supports DICOM connectivity, JPEG/wavelet compression, multi-monitor configurations, and 3D rendering. Features include standard image processing tools (window/level, ROI, distance/angle measurements, annotation).

Indications for Use

Indicated for radiologists and medical professionals requiring access to radiological images and reports for primary diagnosis. Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images. Mammographic interpretation requires FDA-approved monitors with at least 5 Mpixel resolution.

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

• DirectView by Kodak (K030781)
• IMPAX by Agfa (K022292)

Submission Summary (Full Text)

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KAa2878

# Advanced Imaging Solutions, LLC

43731 N. 15th St. West, Lancaster CA

[phone] FAX: [phone]

## Summary

JUN 2 7 2007

Summary Preparation Date 3 Dec 2004

## Company Identification

Advanced Imaging Solutions, LLC 43731 N. 15th St West Lancaster CA 93534

#### Contact Person

Ray H. Hashemi, M.D., Ph.D. 43731 N. 15th St. West Lancaster, CA 93534 [phone] fax: [phone] [e-mail]

#### Device Identification

| Trade Name: | EZPACS® |
|-----------------|------------------------------------------------|
| Common Name: | Picture Archiving Communications System (PACS) |
| Classification: | Class II (Product Code: LLZ) |

#### Predicate Devices

DirectView by Kodak (K030781 approved 5/29/03) IMPAX by Agfa (K022292 approved 9/12/02)

#### Description of Device

EZPACS® is a PACS system that runs on off-the-shelf monitors and PCs running the Microsoft Windows® operating system. It consists of software that displays images and provides functions for image manipulation, enhancement, compression and quantification.

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#### Intended Use

EZPACS® is intended for use by radiologists (for primary diagnosis), and other medical professionals.

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

#### Substantial Equivalence

| | EZPACS | IMPAX | DirectView |
|-------------------------------------------------------|--------|-------|------------|
| Commercial PCs running<br>Windows® O/S | yes | yes | yes |
| Commercial monitors | yes | yes | yes |
| Multi-monitor support | yes | yes | yes |
| JPEG/wavelet compression | yes | yes | yes |
| DICOM conformance | yes | yes | yes |
| Measurement tools (ROI, distance, angle) | yes | yes | yes |
| Viewing tools (window/level, magnify, pan, annotation | yes | yes | yes |
| Comparison cases | yes | yes | yes |
| Cine/stack view | yes | yes | yes |
| Supports teleradiology | yes | yes | yes |
| 3D viewing | yes | yes | yes |

The EZPACS® software is substantially equivalent to IMPAX and DirectView in functions, features, intended use, hardware, safety and effectiveness. Any differences have no significant effect on safety and effectiveness.

#### Conclusion

The EZPACS® software has the same intended use, features, safety and effectiveness as IMPAX and DirectView, therefore it is substantially equivalent to the predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN 2 7 2007

Ray Hashemi, M.D., Ph.D. CEO Advance Imaging Solutions, LLC 43731 N. 15th St. West LANCASTER CA 93534

Re: K062878

Trade/Device Name: EZPACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 14, 2007 Received: May 16, 2007

Dear Dr. Hashemi:

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 (Premarket Approval), 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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Enclosure

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). 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/cdrl/industry/support/index.html

Sincerely yours,

Nancy Chogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indication for Use

Re: EZPACS

510(k)# K062878

EZPACS® is intended for use by radiologists (for primary diagnosis), and other medical professionals who needs access to radiological images and reports.

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

[x] Prescription Use

[ ] Non Prescription Use

Herbert Reinerth

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K062878