(274 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard PACS functionalities like image display, manipulation, enhancement, compression, and quantification, without mentioning any AI/ML-specific features.
No
The device is a PACS system intended for displaying and manipulating radiological images for diagnosis, not for providing therapy.
Yes
Explanation: The device is intended for use by radiologists for "primary diagnosis," indicating its role in identifying diseases or conditions from medical images.
Yes
The device description explicitly states that EZPACS® "consists of software that displays images and provides functions for image manipulation, enhancement, compression and quantification" and runs on "off-the-shelf monitors and PCs running the Microsoft Windows® operating system." This indicates the device itself is the software, relying on commercially available hardware for operation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- EZPACS® function: EZPACS® is a PACS (Picture Archiving and Communication System) system. Its primary function is to display, manipulate, and manage medical images (specifically radiological images). It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for accessing and reviewing radiological images and reports for diagnosis. This is related to medical imaging, not in vitro testing.
Therefore, EZPACS® falls under the category of medical imaging software/systems, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
LLZ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists (for primary diagnosis), and other medical professionals
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
KAa2878
Advanced Imaging Solutions, LLC
43731 N. 15th St. West, Lancaster CA
(661) 949-2131 FAX: (661) 940-0994
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 (661) 949-8111 fax: (661) 940-0994 aic@qnet.com
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.
1
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 | |||
| 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.
2
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.
Image /page/2/Picture/9 description: The image shows a logo and some text. The logo is for the FDA Centennial, with the years 1906-2006. Below the logo is the text "Protecting and Promoting Public Health". The text is in a decorative font.
3
Page 2 -
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 (800) 638-2041 or (240) 276-3150
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