(14 days)
Not Found
No
The summary describes a standard medical display monitor with adjustable gamma settings for image review. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image analysis or processing beyond basic display functions.
No
The device is a medical display used for reviewing images, not for actively treating or diagnosing a condition.
No
The device is a medical display, used for displaying images for review and analysis by medical practitioners for diagnosis, but it does not perform the diagnosis itself. Its function is to present data, not interpret it.
No
The device description explicitly states it is a "21.3" color LCD monitor," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that this device is a medical display intended for displaying images from modalities like CT, MRI, HIS, and PACS for review and analysis by medical practitioners. It is a display device, not a device that performs tests on biological samples.
The device's purpose is to visualize medical images, which is a different function than performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Medical Display, MDC2130-2HC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Medical Display, MDC2130-2HC is a 21.3" color LCD monitor that displays image for medical use. It provides 2 mega pixel (1600 x 1200) resolution and enable the user to define desired DICOM GSDF Gamma settings such as 1.8, 2.0 and 2.2 for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
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
trained medical practitioner for diagnose in CT, MRI, HIS and PACS.
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
510(K) Summary of Safety and Effectiveness
As required by 807.92
DEVICE ESTABLISHMENT AND CONTACT PERSON 1.
DEC / 4 2006
Phil Chen CHILIN TECHNOLOGY CO., LTD. No.71, Te Lun Road, Jen Te Hsian, Tainan County 717, Taiwan, R.O.C. Ph: +886-6-279 - 4113 ext. 533 Facsimile: +886-6-249 -- 4751
2. DATE SUMMARY PREPARED
08 September 2006
3. DEVICE NAME
Trade Name: Medical Display, MDC2130-2HC Common Name: Color LCD Monitor, Monochrome Diagnostic Display, etc.
Classification Name: System, Image Processing, Radiological (CLASS II CFR 892.2050)
4. PREDICATE DEVICE
Medical Display - MDC1900-1LG 19" color LCD Monitor by CHILIN TECHNOLOGY CO., LTD. (K061305).
5. DEVICE DESCRIPTION
Medical Display, MDC2130-2HC is a 21.3" color LCD monitor that displays image for medical use. It provides 2 mega pixel (1600 x 1200) resolution and enable the user to define desired DICOM GSDF Gamma settings such as 1.8, 2.0 and 2.2 for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
6. DEVICE OF INTEND USE
Medical Display, MDC2130-2HC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system
1
7. CONCLUSION
:
Medical Display, MDC2130-2HC has the same intended use as the predicate device MDC1900-1LG, and they both share the similar characteristics except some minor differences which do not raise new questions of safety and effectiveness. The device does not contact with the patient nor does it control any life sustaining device. Therefore we concluded that it is substantially equivalent to MDC1900-1LG by CHILIN TECHNOLOGY CO., LTD. (K061305).
2
Third Party Review Quality Assessment
Section 1 - Submission Information
ﻟﺪﻳﻨﺎ
| 510(k) No.: | K063579 |
|---|---|
| Third Party Organization: | Underwriters Inc |
| Third Party's Primary Reviewer(s): | Thomas Huang |
| ODE/OIVD Division: | ODE |
| Branch/Team: | DRARD / RADB |
Section 2 - 510(k) Decision
| Third party recommendation: | SE ✓ NSE ______ Other (specify): ______ |
|---|---|
| ODE/OIVD final decision: | SE ✓ NSE ______ Other (specify): ______ |
Section 3 - Assessment of Third Party Review
| Review Element | Rating (check one) | |||
|---|---|---|---|---|
| Adequate | Minor | |||
| Issue(s) | Major | |||
| Issue(s) | ||||
| a. Determination of device eligibility for third party review | ✓ | |||
| b. Extent of pre-submission consultation with ODE/OIVD division | ||||
| c. Organization and format of review documentation | ||||
| d. Determination of 510(k) administrative completeness (screening | ||||
| review) | ||||
| e. Summary of device characteristics, intended use, and performance | ||||
| (including accessories, if applicable) and reason for 510(k) submission | ✓ | |||
| f. Comparison to legally marketed devices-identification and analysis of | ||||
| key similarities and differences | ||||
| g. Rationale for conclusions and recommendation | ✓ | ✓ | ||
| h. Use of guidance documents and standards | ||||
| i. Resolution of 510(k) deficiencies and FDA requests for additional | ||||
| information | ||||
| j. Scope of reviewer expertise and use of consulting reviewers | ||||
| k. Other (specify): |
Comments (explanation of ratings/issues):
Section 4 - ODE/OIVD Assessur Intornation
Assessed by: Khan
Date: 12-5-06 Tel No: 276
Routing) Division Chp completed assessment (this page only) (o inside from cover of >(0) DMC Town addition page only to Rechen, POS/ODF, Rin 1209, Corp. Blvd. (HF/ 2011
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
DEC 1 4 2006
CHI LIN Technology Co., Ltd. c/o Mr. Marc M. Mouser Sr. Project Engineer, Program Reviewer Underwriter Laboratories, Inc. 2600 N. W. Lake Road CAMAS WA 98607-8542
Re: K063579
Trade/Device Name: Medical Display, MDC2130-2HC Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 13, 2006 Received: November 30, 2006
Dear Mr. Mouser:
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 (Premarket Approval), 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.
Image /page/3/Picture/10 description: The image shows a circular logo for the FDA Centennial 1906-2006. The logo features the letters "FDA" in a stylized font, with the word "Centennial" written below. Three stars are placed below the word "Centennial". The logo is surrounded by text that follows the circular shape.
ng and Promoting Public St
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Page 2 -
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.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
5
Indications for Use
510(k) Number (if known):
Device Name: Medical Display, MDC2130-2HC
Indications For Use: 2MP Medical Color Reference Display, MDC2130-2HC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________