(89 days)
Not Found
No
The summary describes a medical display device and does not mention AI, ML, or any related technologies in its description, intended use, or performance studies.
No
The device is a display for viewing digital images, specifically for digital mammography applications, for review by trained medical practitioners. It does not perform any therapeutic function.
Yes
The device is described as a "grayscale diagnostic medical display" and is intended for "displaying and viewing digital images for review by trained medical practitioners," especially for "digital mammography applications." These uses clearly align with the definition of a diagnostic device.
No
The device is described as a "grayscale diagnostic medical display," which is a hardware component used for viewing medical images. While it processes digital images, the core device is a physical display, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "displaying and viewing digital images for review by trained medical practitioners." This describes a device used for visualizing medical images, not for performing tests on biological samples to diagnose conditions.
- Device Description: It's described as a "grayscale diagnostic medical display." This reinforces its function as a display device.
- 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.)
- Using reagents or assays
- Providing a diagnostic result based on the analysis of a sample
The device is a medical display intended for viewing images, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The SMD 21500 / DSB-2103-D-5MP device is intended to be used in displaying and viewing digital images for review by trained medical practitioners. It is especially designed for digital mammography applications.
Product codes
90LLZ
Device Description
The SMD 21500 / DSB-2103-D-5MP is a grayscale diagnostic medical display
Mentions image processing
System, Image Processing
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 practitioners
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)
Barco Coronis 5MP HD (K041508)
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
K04322
FEB - 9 2005 510(k) Summary
| Date of Application: | November 1, 2004 |
|---|---|
| Manufacturer: | Siemens AG |
| A&D SE DT - Display Technologies | |
| 84 Siemensallee | |
| Karlsruhe, Germany 76187 | |
| Contact Information: | George Scott |
| Marketing Manager, U.S. | |
| Siemens Display Technologies | |
| Ph: 303-604-6760 | |
| Fax: 303-664-0727 | |
| Email: george.scott@siemens.com | |
| Classification Name: | System, Image Processing |
| Common/Usual Name: | Image Display Device, Medical Imaging |
| Proprietary Name/Model: | SMD 21500 or DSB-2103-D-5MP - 5M Pixel |
| Grayscale Flat Panel Display | |
| Device Ordering Codes: | 6GF6201-4Cxxx (where xxx represents |
| specific customer version) | |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Barco Coronis 5MP HD (K041508) |
| Device Description: | The SMD 21500 / DSB-2103-D-5MP is a |
| grayscale diagnostic medical display | |
| Intended Use: | The SMD 21500 / DSB-2103-D-5MP device is |
| intended to be used in displaying and viewing | |
| digital images for review by trained medical | |
| practitioners. It is especially designed for | |
| digital mammography applications. | |
| Technological Characteristics: | The SMD 21500 / DSB-2103-D-5MP device is |
| a high-resolution display with electronic | |
| capabilities for evaluation of high-resolution | |
| medical images. | |
| (See separate comparison chart to predicate | |
| device) |
:
1
Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 2005
Siemens AG % Mr. George Scott Marketing Manager Siemens Energy & Automation, Inc. Power Control Division 515 Courtney Way, Suite A LAFAYETTE CO 80026
Re: K043122 Trade/Device Name: SMD 21500 / DSB-2103-D-5MP 5M Pixel Grayscale Flat Panel Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: January 18, 2005 Received: January 18, 2005
Dear Mr. Scott:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your corned 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 the enorolours) to teening time Medical Device Amendments, or to devices that have been May 20, 1770, the charactering 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 do not require approvince of the Act. The general controls provisions of the Act. The Act de not, subject to the general 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 n your as the to be subject to such additional controls. Existing major regulations affecting your Apploval), It they of Subject 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 I rease of advisor 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 I caraf statues and regularing, 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) (21 CFR Part 807), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter will and will be region mading of substantial equivalence of your device to a legally premaired notification: "Thesults 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 If you desire specific at not of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regaration on your responsibilities under the Act from the 807.77). Tou may oouall carees, International and Consumer Assistance at its toll-free number (800) DIVISION of Shian Hamanavia 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
3
Statement of Indications for Use
Ko43122 510(k) Number:
Device Name:
Indications for Use:
SMD 21500 / DSB-2103-D-5MP — 5M Pixel Grayscale Flat Panel Display
The SMD 21500 / DSB-2103-D-5MP device is intended to be used in displaying and viewing digital images for review by trained medical practitioners. It is especially designed for digital mammography applications.
Prescription Use
David B. Lonsman
(Division Sign-Off) Productive, Sign-Off)
Division of Reproductive, Abdominal, 5 100 Radiological Devices 5 10(k) Number