(52 days)
None
Not Found
No
The document describes a software workstation for quality assurance of computed radiography images and does not mention AI or ML capabilities.
No
The device is described as a "Quality Assurance (CR/QA) Workstation" used to process and view computed radiography images, which indicates a diagnostic or imaging review function, not a therapeutic one.
No
The device is described as a "Quality Assurance (CR/QA) Workstation" that aids with and connects to computed radiography images. Its stated purpose is quality assurance, not diagnosing medical conditions or diseases.
Yes
The device is described as a "Web based software product" and a "Workstation" that aids with and connects to images from various sources. There is no mention of any accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "Web based software product that will aid with and connect to computed radiography images...". This indicates a focus on image management, processing, and potentially quality assurance of the imaging system itself, rather than analyzing biological samples or providing diagnostic information directly from a patient's biological material.
- Device Description: The description "WEBRAD Computed Radiography Quality Assurance (CR/QA) Workstation" further reinforces the focus on quality assurance related to the imaging process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific biomarkers, or providing diagnostic results based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function appears to be related to the technical aspects and quality of medical images, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The WebRad Computed Radiography Quality Assurance (CR/QA) Workstation is a Web based software product that will aid with quality assurance of computed radiography images acquired from a FUJI Computed Radiography system or other medical imaging modalities, film digitizers and image phosphor plate scanners.
Product codes
90 LLZ
Device Description
WEBRAD Computed Radiography Quality Assurance (CR/QA) Workstation
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
computed radiography images, medical imaging modalities, film digitizers, image phosphor plate scanners
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
1
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