(191 days)
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No
The summary describes a medical display panel, which is a hardware component for viewing images, not a software or system that processes or analyzes data using AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is a display for medical images, not a tool for treatment or diagnosis.
No
Explanation: This device is a display panel for medical imaging and is used by physicians for PACS. It is a tool for viewing diagnostic images, but it does not perform the diagnostic function itself.
No
The device is described as a "Medical Flat Panel Display," which is a hardware component used for displaying medical images. The description does not indicate it is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use with PACS for medical imaging applications by physicians. This describes a device used to display medical images, not a device used to perform tests on biological samples (which is the core function of an IVD).
- Device Description, Image Processing, AI/ML: The lack of information in these sections further supports that this is a display device, not a diagnostic test.
- Input Imaging Modality: "medical imaging" refers to the source of the images being displayed, not a biological sample being analyzed.
- Intended User: Physicians are the users, but they are using the device to view images, not to perform a diagnostic test on a sample.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. A medical display is a tool for viewing the results of imaging modalities, which are a different category of medical device.
N/A
Intended Use / Indications for Use
3M Color Medical Flat Panel Display, CCL316, is intended for use with Picture Archiving Communication Systems (PACS) for medical imaging application by physicians. It is not meant to be used for digital mammography.
Product codes
90 LLZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
physicians
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.)
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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).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 a bird in flight. The symbol is composed of three curved lines that create a sense of movement and dynamism.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 26 2004
Mr. Mikio Hasegawa General Manager TOTOKU ELECTRIC CO., LTD. MM Company, Design Group 300 Oya, Ueda, Nagano 386-0192 JAPAN
Re: K032555 Trade/Device Name: 3M Color Medical Flat Panel Display, CCL316 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: February 6, 2004 Received: February 5, 2004
Dear Mr. Hasegawa:
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. Iisting 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 such 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 (2) 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 to proceed to the market.
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. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
2
510(k) Number: K032555
3M Color Medical Flat Panel Display, CCL316 Device Name:
Indications for Use:
3M Color Medical Flat Panel Display, CCL316, is intended for use with Picture Archiving Communication Systems (PACS) for medical imaging application by physicians. It is not meant to be used for digital mammography.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
✓
OR Over-The-Counter Use
(Optional Format 1-2-96)
David A. Lemon
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devic 510(k) Number _