(41 days)
No
The summary describes a device for transmitting and synchronizing radiographic images and data, with no mention of AI or ML capabilities for image analysis, processing, or decision support.
No
The device is described as an Image Management System (IMS) that transmits, stores, and connects radiographic images, not as a device that delivers therapy or treatment.
No
Explanation: The device is described as an image management system that transmits radiographic images and patient data, and provides network connections. Its functions relate to image handling and connectivity for output devices, not to making a medical diagnosis or providing diagnostic information.
No
The device description explicitly states it provides a network connection via DICOM protocol to various output devices from a radiographic system which uses a digital image capture device. It also synchronizes the ready states of the digital image capture device and the radiographic equipment. This indicates interaction with and reliance on hardware components (radiographic equipment and digital image capture device), making it more than just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the transmission of radiographic images and associated data. This is related to medical imaging, not the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The device description focuses on network connectivity, DICOM protocol, and synchronization of radiographic equipment. This is a technical function related to image handling and workflow, not diagnostic testing performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
The device is clearly related to medical imaging and likely falls under the category of medical image management or communication systems.
N/A
Intended Use / Indications for Use
The DEL-IMS has application wherever the transmission of radiographic images and associated patient text data is desired to take place from an input, such as radiographic equipment which employs a digital image capture device, to an output device such as hardcopy, softcopy, or archive device.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Product codes
LLZ
Device Description
The DEL-IMS is intended to provide a network connection via DICOM protocol to various output (e.g. hardcopy, softcopy and archive) devices from a radiographic system which uses a digital image capture device. It synchronizes the ready states of the digital image capture device and the radiographic equipment when a single x-ray console is desired, to provide the x-ray console features (e.g. technique selection) of the radiographic equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic images
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)
Sterling DROC, (K980970)
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
长06 3188
510 (k) Summary
:
This summary of safety and effectiveness information is submitted in accordance with the requirements of
21 CEP 807 92 21 CFR 807.92.
| Submitter: | Del Medical Imaging
11550 W. King St.
Franklin Park, IL 60131 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bill Engel
Manager, QA/RA
Phone: 847-288-7948
Fax: 847-288-7011
Email: wengel@delmedical.com |
| Date Prepared: | October 17, 2006 |
| Trade Name: | DEL-IMS |
| Common Name: | Operator Console and Imaging Workstation for Stationary Digital X-Ray Systems |
| Classification Name: | 892.2050 Picture Archiving and Communications Device |
| Predicate Device: | Sterling DROC, (K980970). |
| Product Description: | The DEL-IMS is intended to provide a network connection via DICOM protocol to various output
(e.g. hardcopy, softcopy and archive) devices from a radiographic system which uses a digital
image capture device. It synchronizes the ready states of the digital image capture device and the
radiographic equipment when a single x-ray console is desired, to provide the x-ray console
features (e.g. technique selection) of the radiographic equipment. |
| Indication for Use: | The DEL-IMS has application wherever the transmission of radiographic images and
associated patient text data is desired to take place from an input, such as radiographic
equipment which employs a digital image capture device, to an output device such as
hardcopy, softcopy, or archive device.
Lossy compressed mammographic images and digitized film screen images must not be
reviewed for primary image interpretations. Mammographic images may only be interpreted
using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other
technical specifications reviewed and accepted by FDA. |
| Rationale for
Substantial Equivalence: | The DEL-IMS has the same indication for use as the predicate device. It shares the same
technological characteristics as the predicate device. Minor technological differences do not raise
any new questions regarding safety or effectiveness of the device. |
| Safety and
Effectiveness Information: | The device labeling contains operating instructions for safe and effective use of the DEL-IMS. The
software development for this device follows documented processes for software design,
verification and validation testing. Final device validation and risk assessment will be completed
prior to marketing, to identify potential design hazards that could cause an error or injury based on
the use of this device. Appropriate steps will be taken to control all identified risks. The device will
be tested for compliance to IEC 60601-1- 2 Medical Electrical Equipment Part 1: General
Requirements for Safety. |
| Conclusion: | The DEL-IMS performs the same functions in the same environment as the predict device
(DROC). It is as safe and effective as the predict device. We believe it does not introduce any new
potential safety risks and is substantially equivalent to the predict device. |
1
Image /page/1/Picture/1 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Blvd., Rockville MD 20850. The text is black and the background is white. The text is left-aligned.
NOV 3 0 2006
Mr. William J. Engel Manager, Quality Assurance/Regulatory Affairs Del Medical Systems Group 11550 West King Street FRANKLIN PARK IL 60131
Re: K063188
Trade/Device Name: DEL-IMS Digital Operator Console Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 17, 2006 Received: October 23, 2006
Dear Mr. Engel:
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/1/Picture/9 description: The image is a circular logo or emblem. The text "1906-2006" is at the top, and the letters "FDA" are prominently displayed in the center. Below "FDA" is the word "Centennial". There are three small dots arranged horizontally beneath the word "Centennial". The entire design is enclosed within a circular border.
Protecting and Promoting Public Health
2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA S ISSuance of a succession of the requirements of the Act
that FDA has made a determination that your device complies with connise. You must that FDA has made a delemination that your as recess. Your crederal agencies. You must of or any Federal statules and regulations administers of ey not limited to: registration and listing (21 comply with all the Act Stequirements, mercess, confecturing practice requirements as set CFR Part 807); iabeling (21 CFR Parts of ); good frances (20); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applic forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) This letter will allow you to begin maketing your over articlequivalence of your device to a legally premarket notification. The FDA midnig of succement of the more 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 advice for your device on 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" Also, please note the regulation other general information on your responsibilities under (21CFR Part 807.97). Tou may obtain other general and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indication for Use Statement
510k Number: (if known): Ko 3188
Device Name: DEL-IMS Digital Operator Console
Indications for Use:
The DEL-IMS has application wherever the transmission of radiographic images The DEL-IMS flas application wherever the transmission of the an input, such as input, such as and associated patient text data is abon a digital image capture device, to an output device such as hardcopy, softcopy, or archive device.
Lossy compressed mammographic images and digitized film screen images must Lossy contipressed manihographic image interpretations. Mammographic images may not be leviewed for primary intage into proved monitor that offers at least 5 Mpixel orny be interpreted using an PDA upproved monton reviewed and accepted by FDA.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use | ✓ | OR | Over-The-Counter |
---|---|---|---|
------------------ | -------------- | ---- | ------------------ |
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off) | Nancy C Brogdon |
---|---|
Division of Reproductive, Abdominal, and Radiological Devices | |
510(k) Number | K063188 |