(63 days)
Not Found
Not Found
No
The summary describes image processing for magnification but does not mention AI, ML, or related concepts, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device aids in visualization for diagnosis, but it does not directly treat a condition.
No
The device is intended to provide better visualization of existing mammographic films for review by radiologists, essentially magnifying a portion of the film. It does not generate a diagnosis or provide diagnostic output itself, but rather aids in the visualization of diagnostic images.
No
The description explicitly mentions a "hand-held device" and the digitization of a film image, implying the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens taken from the human body. The intended use and device description clearly state that this device is used to visualize mammographic films. These films are images of the breast, not biological specimens.
- The device processes and displays images. It does not perform any tests or analyses on biological samples to diagnose or monitor a condition.
The device appears to be a medical imaging accessory designed to aid radiologists in reviewing existing mammographic images.
N/A
Intended Use / Indications for Use
The hand-held device is intended to provide better visualization of mammographic films for review by radiologists. A portion of the film image is digitized, processed, and displayed in real-time as a magnified view on an adjacent monitor.
Product codes
90 LLZ
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
mammographic films
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists
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
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2003 JUL
Dr. James K. Walker Vice President and Director of Regulatory Affairs Maxxvision, LLC 3014 NE 21st Way GAINSVILLE FL 32609
Re: K031372
Trade/Device Name: Personal Digital Workstation® (PDW) Film Digitizing Camera and Digital Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: April 25, 2003 Received: April 30, 2003
Dear Dr. Walker:
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 (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 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.
1
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
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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
to proceed to the market.
2
2.2 FDA Indications for Use Form
Page of
510(k) Number (if known): K 031372
Device Name: Personal Digital Workstation®
Indications for Use:
The hand-held device is intended to provide better visualization of mammographic films for review by radiologists. A portion of the film image is digitized, processed, and displayed in real-time as a magnified view on an adjacent monitor.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use ✓
Harvey C. Snoddon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number KO31372