(88 days)
Not Found
No
The summary describes a medical display, which is a hardware device for viewing images. There is no mention of any software or processing capabilities that would suggest the use of AI or ML. The "Not Found" entries for image processing, AI/ML mentions, and performance studies further support this conclusion.
No
The device is a medical display for viewing images, not for providing therapy. Therapeutic devices actively treat or manage a disease or condition.
Yes
The predicate device (Totoku ME311L 3 Mega Pixel Diagnostic Display) is explicitly labeled as a "Diagnostic Display," which indicates that the CDL Series Medical Displays, as a similar device, are also intended for diagnostic use.
No
The device description explicitly states "CDL Series Medical Displays are displays for medical use," indicating a hardware component (the display itself).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "viewing digital medical images." This describes a device used to display images generated from the body, not a device used to test samples (like blood, urine, or tissue) outside of the body to diagnose conditions.
- Device Description: The description "displays for medical use" further supports that it's a display device, not a diagnostic test.
- Lack of IVD Characteristics: The information provided does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The device is clearly a medical display intended for viewing images, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
CDL Series Medical Displays are intended for use in viewing digital medical images.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
CDL Series Medical Displays are displays for medical use.
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
Not Found
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
APR 2 5 2003
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
Official Correspondent 2.
Mikio Hasegawa (Mr.) General Manager Product Development Dept.
Date of Submission 3.
Jan. 24, 2003
Device Trade Name 4.
Flat Panel Displays, CDL Series
Common Name న్.
Monitor, display, workstation, and others
Classification 6.
Medical displays are classified as Class I or II per 21 CFR 890.2050
Predicate Device 7.
Totoku ME311L 3 Mega Pixel Diagnostic Display, manufactured by Totoku Electric Co., Ltd. (K012099). Comparison of the principle characteristics of the device which is pertinent to clinical performance is shown in Appendix 1.
Description of Device 8.
CDL Series Medical Displays are displays for medical use.
Intended Use 9.
CDL Series Medical Displays are intended for use in viewing digital medical images.
1
10. Explanation of CDL Series
CDL Series consists of color LCD displays listed below. Model No. CDL1811A Model No. CDL1813A
Comparison of specifications are shown in Appendix 2.
11. Compliance
All CDL Series listed above comply with the following standards. Medical Safety: UL2601-1, CSA No. 601-1, MDD/CE (EN60601-1, IEC60601-1)
MDD/CE (EN60601-1-2), IEC60601-1-2, and FCC-B EMC:
2
Specification Comparison Chart with Predicate Device Appendix 1
| Item | ME311L | CDL1811A |
|---|---|---|
| 510(k) Number | K012099 | Not known |
| Display area | Horizontal:423.9mm, Vertical:318.0mm | Horizontal: 359.0mm, Vertical: 287.2mm |
| Input signal | GVIF video signal | |
| 10214-1210VE (3M:MDR14P) | D-SUB (analog), DVI-D (digital) | |
| Maximum display pixels | Portrait: 1536 dots X 2048 line | |
| Landscape: 2048 dots X 1536 line | 1280 X 1024 dots | |
| Scanning frequency | Horizontal:93KHz, Vertical:60Hz | Horizontal: 31K - 80KHz, Vertical: 55 - 85Hz |
| Maximum image clock | 65MHz | 135MHz |
| Maxmum brightness | 600cd/m2 | 240cd/m2 |
| Brightness calibration | Software(option) | |
| Photosensor(option item)-DTP92(X-Lite) | ||
| Serial communication connector | D-sub 9P x 2 | 15P Mini D-SUB, 24P DVI-D, 4P DC input terminal |
| 9p Mini D-SUB serial (RS232C) | ||
| Agency standards | Medical safety:UL2601-1,CSA No.601-1 | |
| EN60601-1 | ||
| MDD/CE:(EN60601-1, EN60601-1-2) | Medical safety: UL2601-1,CSA CSA C22.2No.601.1 | |
| (EN60601-1), FCC Class B, DOC-B, BSMI | ||
| Dimensions and weight | ||
| (incl. Tilt and swivel) | 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: 432x353x68.6mm(W x H x D) (landscape) 6.9kg | |
| Packed: 485x600x280mm(W x H x D) 12kg | ||
| Power supply | 100-240V AC, 50/60Hz | 100-250V AC, 50/60Hz |
3
Appendix 2 Specification Comparison Chart of the Applied Models
| Item | CDL1811A | CDL1813A |
|---|---|---|
| 510(k) Number | Not known | Not known |
| Display area | Horizontal: 359.0mm, Vertical: 287.2mm | Horizontal: 359.0mm, Vertical: 287.2mm |
| Input signal | D-SUB (analog), DVI-D (digital) | D-SUB (analog), DVI-D (digital) |
| Maximum display pixels | 1280 X 1024 dots | 1280 X 1024 dots |
| Scanning frequency | Horizontal: 31K - 80KHz, Vertical: 55 - 85Hz | Horizontal: 31K - 80KHz, Vertical: 55 - 85Hz |
| Maximum image clock | 135MHz | 135MHz |
| Maxmum brightness | 240cd/m2 | 240cd/m2 |
| Brightness calibration | - | - |
| Serial communication connector | 15P Mini D-SUB, 24P DVI-D, 4P DC input terminal | |
| 9p Mini D-SUB serial (RS232C) | 15P Mini D-SUB, 24P DVI-D, 4P DC input terminal | |
| 9p Mini D-SUB serial (RS232C) | ||
| Agency standards | Medical safety: UL2601-1,CSA CSA C22.2No.601.1 | |
| (EN60601-1), FCC Class B, DOC-B, BSMI | Medical safety: UL2601-1,CSA CSA C22.2No.601.1 | |
| (EN60601-1), FCC Class B, DOC-B, BSMI | ||
| Dimensions and weight | Net: 432x353x68.6mm(W x H x D) (landscape) 6.9kg | |
| Packed: 485x600x280mm(W x H x D) 12kg | Net: 432x353x68.6mm(W x H x D) (landscape) 6.9kg | |
| Packed: 485x600x280mm(W x H x D) 12kg | ||
| Power supply | 100-250V AC, 50/60Hz | 100-250V AC, 50/60Hz |
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mikio Hasegawa General Manager Totoku Electric Co., Ltd. Product Development Dept., MM Company 300 Oya. Ueda-shi Nagano 286-0192 JAPAN
Re: K030276 Trade/Device Name: Flat Panel Display, CDL Series 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, 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.
APR 2 5 2003
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 vours.
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
6
510(k) Number (If known): Not known KO30
Device Name: Flat Panel Displays, CDL Series
Indications for Use:
CDL Series Medical Displays are intended for use in viewing digital medical images.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030276
Prescription Use the markdown representing the content of the image is:Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030276
Prescription Use OR Over-The-Counter Use
(Optional Format 1-2-96)