(83 days)
Not Found
No
The document describes medical displays and does not mention any AI or ML capabilities.
No
The device is a medical display for viewing images, not for treating any medical condition or disease.
No
The device is described as a display for medical imaging applications, intended for use by physicians with PACS. It does not perform diagnostic functions itself, but rather presents images for the physician to diagnose. Furthermore, one of its predicate devices is explicitly named "Diagnostic Display", suggesting this device is similar in function (i.e. displaying for diagnosis, not diagnosing).
No
The device description explicitly states that the devices are "displays for medical use" and lists specific models of "monochrome LCD displays" and "color LCD displays," indicating they are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for displaying medical images from PACS for physicians. This is a display device, not a device that performs tests on biological samples.
- Device Description: The description clearly states they are "displays for medical use."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing any kind of diagnostic test on patient specimens.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to present visual information, not to analyze biological material.
N/A
Intended Use / Indications for Use
The ME and CCL Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.
Product codes
90 LLZ
Device Description
The ME and CCL Series Medical Displays are displays for medical use.
ME Series are monochrome LCD displays consists of the following models.
ME181L (Model No. MDL1809A)
ME201L (Model No. MDL2006A)
ME203L (Model No. MDL2004A)
CCL Series are color LCD displays consists of the following models.
CCL182 (Model No. CDL1808A)
CCL202 (Model No. CDL2005A)
CCL314 (Model No. CDL2103A)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
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
510(k) Summary
as required by 807.92
KU21738
Company Identification 1.
Totoku Electric Co., Ltd. 300 Oya, Ueda-shi, Nagano-ken, 386-0192, JAPAN 011-81-268-34-5484 Tel: Fax: 011-82-268-34-5565
Official Correspondent 2.
Mikio Hasegawa (Mr.) General Manager Product Development Dept.
Date of Submission 3.
May 24, 2002
Device Trade Name 4.
Flat Panel Displays, ME Series and CCL Series
Common Name 5.
Monitor, display, workstation, and others
Classification 6.
Medical displays were classified in Class II per 21 CFR 890.2050
Predicate Device 7.
Totoku ME311L 3Mega Pixel Diagnostic Display, manufactured by Totoku Electric Co., Ltd. (K012099). Comparison of the principal characteristics of the one device which is pertinent to clinical performance is shown in Appendix 1.
Description of Device 8.
The ME and CCL Series Medical Displays are displays for medical use.
Intended Use 9.
The ME and CCL Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.
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10. Explanation of ME Series and CCL Series
ME Series are monochrome LCD displays consists of the following models.
ME181L (Model No. MDL1809A)
ME201L (Model No. MDL2006A)
ME203L (Model No. MDL2004A)
CCL Series are color LCD displays consists of the following models.
CCL182 (Model No. CDL1808A)
CCL202 (Model No. CDL2005A)
CCL314 (Model No. CDL2103A)
Comparison of specifications are shown in Appendix 2.
11. Compliance standards
All ME Series are complies with following standards.
Medical Safety: UL2601-1, CSA No. 601-1, IEC60601-1 MDD/CE (EN60601-1)
- EMC: MDD/CE (EN60601-1-2), IEC60601-1-2, FCC-B and VCCI-B for ME181L (MDL1809A) and ME201L (MDL2006A). MDD/CE (EN60601-1-2), IEC60601-1-2, FCC-A and VCCI-A for ME203L (MDL2004A)
All CCL Series are complies with following standards.
ITESafety: UL1950, CSA No.950, LVD/CE(EN60950)
EMC/CE (EN55022, EN55024), FCC-B and VCCI-B EMC: for CCL182 (CDL1808A) and CCL202 (CDL2005A). EMC/CE (EN55022, EN55024),FCC-A and VCCI-A for CCL314 (CDL2103A).
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2002
Mr. Mikio Hasegawa General Manager Totoku Electric Co., Ltd. Product Development Dept. MM Company 300 Oya, Ueda-Shi, Nagano 386-0192 JAPAN
Re: K021738
Trade/Device Name: Medical Flat Panel Displays, ME and CCL Series Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: May 24, 2002 Received: May 28, 2002
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 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,
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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
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510(k) Number (If known): Not known
- K.021738
Flat Panel Display, ME and CCL Series Device Name:
Indications for Use:
The ME and CCL Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging application by physicians.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
David A. Seymon
(Division Sign-Off) Division of Reproductive. and Radiological Device 510(k) Number
Prescription Use V
OR Over-The-Counter Use
(Optional Format 1-2-96)