PAXERAPACS

K132586 · Paxeramed · LLZ · Oct 31, 2013 · Radiology

Device Facts

• Record ID: K132586
• Device Name: PAXERAPACS
• Applicant: Paxeramed
• Product Code: LLZ · Radiology
• Decision Date: Oct 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Paxera PACS is a scalable medical image and informatics system intended to receive, transmit, display, print and process digital images from medical image modality supporting the DICOM 3.0 standard, these modalities are Magnetic Resonance (MR), Computed Tomography (CT) Computed Radiography (CR), Digital X-Ray (DR), Digital Mammography (MG), X-Ray Angiography (XA), Ultrasound (US), Nuclear Medicine (NM), and Positron Emission Tomography (PT). The Paxera PACS workstation provides the user with the ability to display, manipulate, attach diagnostic reports ,archive, transmit and print images using DICOM and other computer industry standard interfaces and standards. Mammography images intended for primary interpretation must be acquired for an FDA approved Full Field Digital Mammography (FDDM) device. In addition, the FDDM device must be able to provide to the Paxera PACS "for presentation" a viewable DICOM image as approved by FDA for primary interpretation. If images are sent to a film printers must be FDA approved for diagnosis of digital mammography images. If digital mammography images are viewed on a display that display must be cleared by the FDA for primary diagnosis of digital mammography images. The Paxera PACS allows for integration with many open interfaces including DICOM, Web Client, and Archiving devices. The Paxera PACS server infrastructure software facilitate database management and image management, printing, HL-7 interfacing and all DICOM services such as Store/Retrieve, Query and Send. The Paxera PACS is intended for use by trained medical professionals including but not limited to, Radiologists, Physicians and Medical Technologists. It is the user's responsibility to ensure quality by taking measures to achieve the proper lighting conditions and image compression ratios consistent with the clinical requirements of the indented use.

Device Story

PaxeraPACS is a scalable medical image and informatics system; receives, transmits, displays, processes, and archives digital medical images from DICOM 3.0 modalities (MR, CT, CR, DR, MG, XA, US, NM, PT). Operates as a server-workstation infrastructure; facilitates database management, image management, printing, and HL-7 interfacing. Used by radiologists, physicians, and medical technologists in clinical settings. Provides tools for image manipulation and diagnostic report attachment. Supports DICOM services (Store/Retrieve, Query, Send) and web client integration. Enables healthcare providers to view and interpret diagnostic images, supporting clinical decision-making through centralized image access and management.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

PACS software architecture; supports DICOM 3.0 standard; integrates with HL-7 interfaces; utilizes web client and server infrastructure for database and image management; supports standard computer industry interfaces for printing and transmission.

Indications for Use

Indicated for trained medical professionals (radiologists, physicians, medical technologists) to receive, transmit, display, process, and archive digital medical images (MR, CT, CR, DR, MG, XA, US, NM, PT) from DICOM 3.0 compliant modalities. Mammography primary interpretation requires FDA-approved FDDM acquisition, display, and printing hardware.

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).

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 31, 2013

Paxeramed Corporation % Mr. Carl Alletto Consultant Otech, Inc. 2001 E. Oak Shores Drive AUBREY TX 76227

Re: K132586

Trade/Device Name: PaxeraPACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 8, 2013 Received: September 5. 2013

Dear Mr. Alletto:

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 substantíal 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 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.

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Page 2-Mr. Alletto

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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 O. O'Hara

for

Janine M. Morris 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): K132586

Device Name: Paxera PACS

## Indications for Use:

The Paxera PACS is a scalable medical image and informatics system intended to receive, transmit, display, print and process digital images from medical image modality supporting the DICOM 3.0 standard, these modalities are Magnetic Resonance (MR), Computed Tomography (CT) Computed Radiography (CR), Digital X-Ray (DR), Digital Mammography (MG), X-Ray Angiography (XA), Ultrasound (US), Nuclear Medicine (NM), and Positron Emission Tomography (PT).

The Paxera PACS workstation provides the user with the ability to display, manipulate, attach diagnostic reports ,archive, transmit and print images using DICOM and other computer industry standard interfaces and standards.

Mammography images intended for primary interpretation must be acquired for an FDA approved Full Field Digital Mammography (FDDM) device. In addition, the FDDM device must be able to provide to the Paxera PACS "for presentation" a viewable DICOM image as approved by FDA for primary interpretation. If images are sent to a film printers must be FDA approved for diagnosis of digital mammography images. If digital mammography images are viewed on a display that display must be cleared by the FDA for primary diagnosis of digital mammography images.

The Paxera PACS allows for integration with many open interfaces including DICOM, Web Client, and Archiving devices. The Paxera PACS server infrastructure software facilitate database management and image management, printing, HL-7 interfacing and all DICOM services such as Store/Retrieve, Query and Send.

The Paxera PACS is intended for use by trained medical professionals including but not limited to, Radiologists, Physicians and Medical Technologists. It is the user's responsibility to ensure quality by taking measures to achieve the proper lighting conditions and image compression ratios consistent with the clinical requirements of the indented use.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K132586

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