WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION

K991626 · Analogic Corp. · LLZ · Jul 2, 1999 · Radiology

Device Facts

• Record ID: K991626
• Device Name: WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION
• Applicant: Analogic Corp.
• Product Code: LLZ · Radiology
• Decision Date: Jul 2, 1999
• Decision: SESE
• Submission Type: Special
• 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 and with and to a modalities, film digitizers and image phosphor plate scanners.

Device Story

WebRad CR/QA Workstation is web-based software for quality assurance of computed radiography images. Device interfaces with FUJI Computed Radiography modalities, film digitizers, and image phosphor plate scanners. Operates in clinical environments; used by radiology staff to manage, review, and ensure quality of digital radiographic images. Facilitates workflow by providing centralized access to image data for quality control purposes.

Clinical Evidence

Bench testing only.

Technological Characteristics

Web-based software workstation; designed for integration with FUJI Computed Radiography modalities, film digitizers, and image phosphor plate scanners. Functions as a digital image quality assurance tool.

Indications for Use

Indicated for use with computed radiography images acquired from FUJI Computed Radiography modalities, film digitizers, and image phosphor plate scanners.

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

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 1999

Garet van Gennep Project Engineer Analogic Corporation 8 Centennial Drive Centennial Industrial Park Peabody, Massachusetts 01960 RE: K991626

WEBRAD Computed Radiography Quality Assurance Workstation Dated: June 2, 1999 Received: June 2, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Gennep:

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 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). 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 III (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 (QS) for Medical Devices: General requlation (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 531 through 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz. M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510 (k) Number (if known): K991626

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 The Webkad Computed Racregiaphy Quantyued radiography images acquired from a FUJI Computed product that will and with and to a modalities, film digitizers and image phosphor plate scanners.

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

Prescription Use
(Per 21 CPR 801.109)

OR

Over-The-Counter-Use _

David W. Ingram

(Optional Format 1-2-96)

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