(88 days)
No
The summary describes a medical display, which is a hardware component for viewing images, and there is no mention of AI or ML in the intended use, device description, or any other section.
No
The device is a medical display used by physicians for medical imaging applications, but it does not directly treat or diagnose a medical condition.
Yes
Explanation: The device is a medical display intended for use with PACS for medical imaging applications, and its predicate device is explicitly described as a "Diagnostic Display." This indicates its role in the diagnostic process.
No
The device description explicitly states it is a "monochrome LCD display," which is a hardware component.
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 Picture Archiving Communication Systems (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 in vitro (outside the body).
- Device Description: The description confirms it's a "display for medical use," specifically a "monochrome LCD display." This aligns with a display device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information about a patient's health status based on laboratory tests
Therefore, the ME183L Medical Display is a medical device used for displaying medical images, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ME183L Medical Display is intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.
Product codes
90 LLZ
Device Description
ME183L is a display for medical use. ME183L is a monochrome LCD display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Company Identification 1.
Totoku Electric Co., Ltd. 300 Oya, Ueda-shi, Nagano-ken, 386-0192, JAPAN Tel: 011-81-268-34-5484 Fax: 011-82-268-34-5565
2. Official Correspondent
Mikio Hasegawa (Mr.) General Manager Product Development Dept.
- Date of Submission 3. Jan. 24, 2003
- Device Trade Name 4. Flat Panel Display, ME183L
Common Name 5.
Monitor, display, workstation, and others
6. Classification
Medical display is classified as Class I or II per 21 CFR 890.2050
7. Predicate Device
Totoku ME311L 3 Mega Pixel Diagnostic Display, manufactured by Totoku Electric Co., Ltd. (K012099). Comparison of the principle characteristics of the one device which is pertinent to clinical performance is shown in Appendix 1.
Description of Device 8.
ME183L is a display for medical use.
9. Intended Use
ME183L Medical Display is intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.
1
10. Explanation of ME183L
ME 183L is a monochrome LCD display. ME183L (Model No. MDL1812A)
Specifications are shown in Appendix 2.
11. Compliance
ME183L complies with the following standards.
Medical Safety: UL2601-1, CSA No. 601-1, MDD/CE (EN60601-1, IEC60601-1), and TUV-GM
EMC: MDD/CE (EN60601-1-2), IEC60601-1-2, FCC-B and VCCI-B
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| Item | ME311L | ME183L | Item | |
|---|---|---|---|---|
| 510(k) Number | K012099 | Not known | 510(k) Number | ME183L |
| Display area | Horizontal:423.9mm, Vertical:318.0mm | Horizontal: 359.0mm, Vertical: 287.2mm | Display area | Not known |
| Horizontal: 359.0mm, Vertical: 287.2mm | ||||
| Input signal | GVIF video signal | |||
| 10214-1210VE (3M:MDR14P) | D-SUB(analog), BNC, | |||
| NTSC/PAL(Y/Cb/Cr), s-Video | Input signal | D-SUB(analog), BNC, | ||
| NTSC/PAL(Y/Cb/Cr), s-Video | ||||
| Maximum display pixels | Portrait: 1536 dots X 2048 line | |||
| Landscape: 2048 dots X 1536 line | 1280 X 1024 dots | Maximum display pixels | 1280 X 1024 dots | |
| Scanning frequency | Horizontal:93KHz, Vertical:60Hz | Horizontal: 30K - 91KHz, Vertical: 50 - 85Hz | Scanning frequency | Horizontal: 30K - 91KHz, Vertical: 50 - 85Hz |
| Maximum image clock | 65MHz | 140MHz | Maximum image clock | 140MHz |
| Maximum brightness | 600cd/m2 | 700cd/m2 | Maximum brightness | 700cd/m2 |
| Brightness calibration | Software(option) | Software(option item) | Brightness calibration | Software(option item) |
| Photosensor(option item)-DTP92(X-Lite) | ||||
| Serial communication connector | Photosensor(option item)-DTP92(X-Lite) | |||
| D-sub 9P x 2 | Photosensor(option item)-DTP92(X-Lite) | |||
| D-SUB 15 x 1 | Serial communication connector | D-SUB 15 x 1 | ||
| Agency standards | Medical safety:UL2601-1,CSA No.601-1 | |||
| EN60601-1 | Medical safety: UL2601-1,CSA CSA C22.2 No.601.1 | |||
| TUV-GM, FCC Class B, MDD/CE(EN60601-1, | ||||
| EN60601-1-2), VCCI-B | Agency standards | Medical safety: UL2601-1,CSA CSA C22.2No.601.1 | ||
| TUV-GM. FCC Class B, MDD/CE(EN60601-1, | ||||
| EN60601-1-2), VCCI-B | ||||
| Dimensions and weight | ||||
| (incl. Tilt and swivel) | MDD/CE:(EN60601-1, EN60601-1-2) | |||
| Net, 486x480x250mm(W x H x D) (landscape) 11kg | ||||
| 380x533x250mm(W x H x D) (portrait) | ||||
| Packed, 733x642x363mm(W x H x D) 17kg | Net: 432x466x251mm(W x H x D) (landscape) 9.5kg | |||
| 353x506x251mm(W x H x D) (portrait) | ||||
| Packed: 470x670x340mm(W x H x D) 14kg | Dimensions and weight | |||
| (incl. Tilt and swivel) | Net: 432x466x251mm(W x H x D) (landscape) 9.5kg | |||
| 353x506x251mm(W x H x D) (portrait) | ||||
| Packed: 470x670x340mm(W x H x D) 14kg | ||||
| Power supply | 100-240V AC, 50/60Hz | Internal power supply 100-240V AC, 50/60Hz | Power supply | Internal power supply 100-240V AC 50/60Hz |
3
Appendix 2 Specifications of the Applied Model
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 2003
Mr. Mikio Hasegawa General Manager Totoku Electric Co., Ltd. Product Development Dept., MM Company 300 Oya, Ueda-shi Nagano 286-0192 JAPAN
Re: K030272 Trade/Device Name: Flat Panel Displav, ME183L Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: January 24, 2003 Received: January 27, 2003
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.
5
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. 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
6
K030272 510(k) Number (If known): Not known
Flat Panel Display, ME183L Device Name:
Indications for Use:
ME183L Medical Display is 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 NECESSARY)
Concurrence of CDRH, Office of Device Evaluation
David A. Ryzwan
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. L030772
OR Over-The-Counter Use
(Optional Format 1 -2-96)
Prescription Use