(26 days)
Not Found
No
The document describes a medical display and does not mention any AI or ML capabilities.
No
The device is a medical display used for viewing medical images, not for treating any medical condition. Its intended use is for physicians to use with PACS for medical imaging applications.
No
Explanation: The device is a medical display used with PACS for medical imaging applications. It displays images but does not actively diagnose. Its predicate device is a "Diagnostic Display," but the provided text for the ME Series does not indicate it performs analysis or diagnosis itself, only display.
No
The device description explicitly states it is a "display for medical use," which is a hardware component. The intended use also refers to "Medical Displays."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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 examine specimens from the human body (like blood, urine, or tissue) to provide diagnostic information.
- Device Description: The description mentions compliance with radiation performance standards, which is relevant to display devices, not IVDs.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on the analysis of specimens.
- Reagents, calibrators, or controls.
The device is a medical display intended for viewing medical images, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The ME Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
The ME Series Medical Displays are displays for medical use. This product complies with Radiation performance standards (21 CFR Chapter J, Sub-chapter J).
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K0/2099
JUL 3 1 2001
510(k) Summary as required by 807.92
1. Company Identification
Totoku Electric Co., Ltd. 300 Oya, Ueda-shi, Nagano-ken , 386-0192, Japan Tel : 011-81-268-34-5484 Fax : 011-81-268-34-5565
2. Official Correspondent
Mikio Hasegawa (Mr.) Manager Design Group
3. Date of Submission
June 7, 2001
4. Device Trade name
Monochrome perfectly flat panel displays, ME Series
5. Common Name
Monitor, display, workstation, and others
6. Classification
Medical displays were classified in Class II per 21 CFR 890.2050.
7. Predicate Device
BARCO MGD 221 2 MegaPixel Diagnostic Display, manufactured by BARCO NV / Display Systems (K000923). Comparison of the principal characteristics of the three devices which are pertinent to clinical performance is shown in Appendix 1.
8. Description of Device
The ME Series Medical Displays are displays for medical use. This product complies with Radiation performance standards (21 CFR Chapter J, Sub-chapter J).
9. Intended Use
The ME Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.
1
- Explanation of ME Series
ME Series consists of the following models.
ME221f (Model No. MDT 2205A) ME222f (Model No. MDT 2210A) ME223f (Model No. MDT 2212A) ME224f (Model No. MDT 2210A) ME521f (Model No. MDT 2209A) ME311L (Model No. MDL 2102A)
Comparison of specifications is shown in Appendix 2.
- Compliance standards
Medical safety: UL2601-1, CSA No.601-1, IEC60601-1, MDD/CE (EN60601-1)
EMC: MDD/CE (EN60601-1-2), FCC-A, VCCI-A, IEC60601-2
Others: DHHS
2
- The state of the state of the states of the states
.
| Item | ME221f/4 | MGD221 | ME221f | ME222f | ME223f*1 | ME224f*2 | ME521f | NOTE | |
|---|---|---|---|---|---|---|---|---|---|
| 510(k) Number | Not known | K000923 | Item | ||||||
| Display area | Horizontal 300mm, vertical 400mm | 300mm x 400mm | 10(k) Number | Not known | Not known | Not known | Not known | Not known | *1 ME223f is identical to ME221f except for CRT focus. |
| Luminescent material | P45 (standard) or P4 (optional) | B4-L8 | Display area | Horizontal 300mm, vertical 400mm | Horizontal 400mm, vertical 300mm | Horizontal 300mm, vertical 400mm | Horizontal 400mm, vertical 300mm | Horizontal 302mm, vertical 378mm | |
| Input signal | Video signal - analog 0.714Vp-p/75 $\Omega$ | ||||||||
| Synchronizing signal - 1.0-5.5Vp-p/3.9k $\Omega$ | |||||||||
| Synchro input - Separate/composite/ | |||||||||
| composite video. | |||||||||
| Connector - BNC and SD-sub 15p (VGA | |||||||||
| connection, Gch for video) | • Signal inputs | ||||||||
| Video input connector type: BNC | |||||||||
| Video input voltage: 0.7 Vpp | |||||||||
| Termination: 75 $\Omega$ | |||||||||
| • Synchronization inputs | |||||||||
| Inputs provided: CS or HS and VS | |||||||||
| Input connector type: BNC | |||||||||
| Termination: 75 $\Omega$ | |||||||||
| Sync input voltage: nominal 0.5Vpp | Luminescent material | P45 (standard) or P4 (optional) | P45 (standard) or P4 (optional) | P45 (standard) or P4 (optional) | P45 (standard) or P4 (optional) | P45 (standard) or P4 (optional) | |||
| Maximum display pixels | 1200 dots x 1600 line | 1280 dots x 1600 line | Input signal | Video signal - analog 0.714Vp-p/75Ω | |||||
| Synchronizing signal - 1.0-5.5Vp-p/3.9kΩ | |||||||||
| Synchro input - Separate/composite/composite video. | |||||||||
| Connector - BNC and SD-sub 15p (VGA connection, Gch for video) | Video signal - analog 0.714Vp-p/75Ω | ||||||||
| Synchronizing signal - 1.0-5.5Vp-p/3.9kΩ | |||||||||
| Synchro input - Separate/composite/composite video. | |||||||||
| Connector - BNC and SD-sub 15p (VGA connection, Gch for video) | Video signal - analog 0.714Vp-p/75Ω | ||||||||
| Synchronizing signal - 1.0-5.5Vp-p/3.9kΩ | |||||||||
| Synchro input - Separate/composite/composite video. | |||||||||
| Connector - BNC and SD-sub 15p (VGA connection, Gch for video) | Video signal - analog 0.714Vp-p/75Ω | ||||||||
| Synchronizing signal - 1.0-5.5Vp-p/3.9kΩ | |||||||||
| Synchro input - Separate/composite/composite video. | |||||||||
| Connector - BNC and SD-sub 15p (VGA connection, Gch for video) | Video signal - analog 0.714Vp-p/50Ω or 75Ω (optional) | ||||||||
| Synchronizing signal - TTL level, negative | |||||||||
| Synchro input - Separate. | |||||||||
| Connector- BNC | *2 ME224f is identical to ME223f except for luminance. | ||||||||
| Scanning frequency | Horizontal 30k-127kHz, vertical 50-180Hz | Horizontal 80-140kHz, Vertical 48-150Hz | Maximum display pixels | 1200 dots x 1600 line | 1600 dots x 1200 line | 1200 dots x 1600 line | 1600 dots x 1200 line | 2048 dots x 2560 line | |
| Maximum image clock | 250MHz | 250MHz | Scanning frequency | Horizontal 30k-127kHz, vertical 50-180Hz | Horizontal 30k-110kHz, vertical 50-180Hz | Horizontal 30k-127kHz, vertical 50-180Hz | Horizontal 30k-110kHz, vertical 50-180Hz | Horizontal 186kHz, vertical 71Hz (fixed) | |
| Maximum luminance | 410 cd/m2 min. (P4 luminescent material) | ||||||||
| for both partial white (20%) and total white | |||||||||
| (100%) | Calibrated: 222cd/m2; 65fL | ||||||||
| Peak: 360cd/m2; 105fL | Maximum image clock | 250MHz | 250MHz | 250MHz | 250MHz | 500MHz | |||
| Luminance calibration | Software (standard item) | ||||||||
| Photosensor (optional item) – DTP92 | |||||||||
| (X-Lite) | Frontal X-Rite DTP92 | Maximum luminance | 410 cd/m² min. (P4 luminescent material) for both partial white (20%) and total white (100%) | 600 cd/m² min. (P45 luminescent material) for both partial white (20%) and total white (100%) | 800 cd/m² min. (P4 luminescent material) for both partial white (20%) and total white (100%) | 600 cd/m² min. (P45 luminescent material) for both partial white (20%) and total white (100%) | 600 cd/m² min. (P45 luminescent material) for both partial white (20%) and total white (100%) | ||
| Serial communication connector | D-sub 9p x 2 | 1 input, 1output | |||||||
| 9600 baud, RS232 | |||||||||
| SUB-D9 male/female connector | |||||||||
| Operational at save state | Luminance calibration | Software (standard item) | Software (standard item) | Software (standard item) | Software (standard item) | Software (standard item) | |||
| Agency standards | Medical safety: UL2601-1, CSA No.601-1, | ||||||||
| IEC 60601-1, MDD/CE (EN60601-1) | |||||||||
| Others: DHHS | Medical safety: UL2601-1, cUL2601-1, | ||||||||
| IEC 60601-1, CE (EN60601-1) | |||||||||
| Others: DHHS | Photosensor (optional item) - DTP92 (X-Lite) | Photosensor (optional item) - DTP92 (X-Lite) | Photosensor (optional item) - DTP92 (X-Lite) | Photosensor (optional item) - DTP92 (X-Lite) | Photosensor (optional item) - DTP92 (X-Lite) | ||||
| Dimensions and weight | |||||||||
| (incl. tilt and swivel) | Net, 412 x 578 x 518 mm (W x H x D) 35kg | ||||||||
| Packed, 560 x 710 x 730 mm (W x H x D) | |||||||||
| 41kg | Unpacked, 400 x 561 x 558 mm, 37.4kg | ||||||||
| Packed, 630 x 780 x 788 mm, 55.9 kg | Serial communication connector | D-sub 9p x 2 | D-sub 9p x 2 | D-sub 9p x 2 | D-sub 9p x 2 | D-sub 9p x 2 | |||
| Power supply | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz | Agency standards | Medical safety: UL2601-1, CSA No.601-1, IEC 60601-1, MDD/CE (EN60601-1) | |||||
| Others: DHHS | Medical safety: UL2601-1, CSA No.601-1, IEC 60601-1, MDD/CE (EN60601-1) | ||||||||
| Others: DHHS | Medical safety: UL2601-1, CSA No.601-1, IEC 60601-1, MDD/CE (EN60601-1) | ||||||||
| Others: DHHS | Medical safety: UL2601-1, CSA No.601-1, IEC 60601-1, MDD/CE (EN60601-1) | ||||||||
| Others: DHHS | Medical safety: UL2601-1, CSA No.601-1, IEC 60601-1, MDD/CE (EN60601-1) | ||||||||
| Others: DHHS | |||||||||
| Dimensions and weight (incl. tilt and swivel) | Net, 412 x 578 x 518 mm (W x H x D) 35kg | ||||||||
| Packed, 560 x 710 x 730 mm (W x H x D) 41kg | Net, 505 x 500 x 515 mm (W x H x D) 35kg | ||||||||
| Packed, 615 x 655 x 650 mm (W x H x D) 40kg | Net, 412 x 578 x 518 mm (W x H x D) 35kg | ||||||||
| Packed, 560 x 710 x 730 mm (W x H x D) 41kg | Net, 505 x 500 x 515 mm (W x H x D) 35kg | ||||||||
| Packed, 615 x 655 x 650 mm (W x H x D) 40kg | Net, 412 x 578 x 552 mm (W x H x D) 35kg | ||||||||
| Packed, 560 x 710 x 730 mm (W x H x D) 41kg | |||||||||
| Power supply | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz |
:
100 100
3
Appendix 2 Comparison table among application model
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal 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 a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2001
Totoku Electric Co., Ltd. % Mr. Shinichi Yamanaka Safety Dept. Cosmos Corporation 319 Akeno, Obata-cho, Watarai-gun Mie-ken, 519-05 JAPAN
Re: K012099 ME Series Medical Display Dated: June 7, 2001 Received: July 5, 2001 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Yamanaka:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the w inave is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices device is substantally cquiraline (tor the materials of the Medical Device Amendments, or to devices matkled in meetstance commerce 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 II (Premarket Approval), it may be subject 11 your device is classince (Sc above) and etaxe to entry vour device can be found in the Code of Federal Regulations, to such and conceller. A substantially equivalent determination assumes compliance with the Current Good Manufacturing I I uc 21, 1 at 3 ove to 099. 11 our of the System Regulation (QS) for Medical Devices: General regulation (21 CFR Part Placitie requirements, as set tour in the Quality Dysterial regultures Administration (FDA) will verify such assumptions. Failure o comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to comply with the Federal Register. Please note: this response to your premarket notification submission does not concenting your device in the Poccal Regions 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 I his when while he 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 11 you deste spothe arrice to your corress of Compliance at (301) 594-4639. 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 807.97). Other general information on your common "Misolanding of Ferences to premation in the Division of Small Manufacturers Assistance at its toll-free number (800) 1638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely vours
Nancy C. bogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
5
KO12099 510(k) Number (If known): Not known
Device Name: Monochrome perfectly flat panel display, ME Series
Indications for Use:
The ME Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
OR Over-The-Counter Use
(Optional Format 1-2-96)
Nancy Broghon
(Division Sign-Off)
Division of Reproductive. Abdominal.
and Radiologi 510(k) Numbe