COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE

K980168 · Analogic Corp. · LLZ · Apr 2, 1998 · Radiology

Device Facts

• Record ID: K980168
• Device Name: COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE
• Applicant: Analogic Corp.
• Product Code: LLZ · Radiology
• Decision Date: Apr 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The WebRad Computed Radiography Quality Assurance (CR/QA) Workstation is a Web based software product that will allow the user to view computed radiography images acquired from a FUJI Computed Radiography System and other imaging modalities.

Device Story

WebRad CR/QA Workstation is web-based software for viewing computed radiography images; inputs include image data from FUJI Computed Radiography Systems and other modalities; output is visual display of medical images for quality assurance; used in clinical settings by healthcare professionals; facilitates image review and quality assessment; supports clinical decision-making by providing access to diagnostic images.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Web-based software workstation; designed for image viewing and quality assurance; compatible with FUJI Computed Radiography Systems and other imaging modalities.

Indications for Use

Indicated for use by clinicians to view computed radiography images acquired from FUJI Computed Radiography Systems and other imaging modalities.

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)

{0}------------------------------------------------

## 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" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract caduceus, a symbol often associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR - 2 1998

K980168

Ronald Luich, P.E. Consultant Analogic Corporation c/o RJL Associates, LLC 86 Boston Post Rd. Waterford, CT 06385

Re:

WebRad Computed Radiography Quality Assurance Workstation Dated: January 7, 1998 Received: January 16, 1998 Regulatory class: Unclassified Procode: 90 LLZ

Dear Mr. Luich:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours,

Killian Yu

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{1}------------------------------------------------

510 (k) Number (if known): K980068

Device Name: WEBRAD Computed Radiography Quality Assurance (CR/QA) Workstation

Indications For Use:

The WebRad Computed Radiography Quality Assurance (CR/QA) Workstation is a Web based software product that will allow the user to view computed radiography images acquired from a FUJI Computed Radiography System and other imaging modalities.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Vinit A. Srymm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 216 510(k) Number

Prescription Use (Per 21 CPR 801.109) OR

Over-The-Counter-Use