DEL-IMS

K063188 · Del Medical Imaging Corp. · LLZ · Nov 30, 2006 · Radiology

Device Facts

• Record ID: K063188
• Device Name: DEL-IMS
• Applicant: Del Medical Imaging Corp.
• Product Code: LLZ · Radiology
• Decision Date: Nov 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended 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.

Device Story

DEL-IMS is an operator console and imaging workstation for stationary digital X-ray systems. It connects to radiographic equipment via DICOM protocol; synchronizes ready states between digital image capture devices and X-ray equipment; provides technique selection features. Used in clinical settings by healthcare professionals. Acts as a central interface for image transmission to hardcopy, softcopy, or archive devices. Facilitates workflow by consolidating console functions and managing data transfer; enables clinicians to view and archive radiographic images.

Clinical Evidence

Bench testing only. Software verification and validation processes were followed. Compliance with IEC 60601-1-2 for medical electrical equipment safety was performed.

Technological Characteristics

Operator console and imaging workstation; DICOM connectivity; software-based control for radiographic equipment; supports digital image capture integration. Complies with IEC 60601-1-2.

Indications for Use

Indicated for transmission of radiographic images and patient data from digital capture devices to output/archive devices. Contraindicated for primary interpretation of lossy compressed mammographic images or digitized film screen images. Mammographic interpretation requires FDA-approved 5 Mpixel monitors.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Sterling DROC (K980970)

Submission Summary (Full Text)

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## 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<br>11550 W. King St.<br>Franklin Park, IL 60131 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bill Engel<br>Manager, QA/RA<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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<br>(e.g. hardcopy, softcopy and archive) devices from a radiographic system which uses a digital<br>image capture device. It synchronizes the ready states of the digital image capture device and the<br>radiographic equipment when a single x-ray console is desired, to provide the x-ray console<br>features (e.g. technique selection) of the radiographic equipment. |
| Indication for Use: | The DEL-IMS has application wherever the transmission of radiographic images and<br>associated patient text data is desired to take place from an input, such as radiographic<br>equipment which employs a digital image capture device, to an output device such as<br>hardcopy, softcopy, or archive device.<br>Lossy compressed mammographic images and digitized film screen images must not be<br>reviewed for primary image interpretations. Mammographic images may only be interpreted<br>using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other<br>technical specifications reviewed and accepted by FDA. |
| Rationale for<br>Substantial Equivalence: | The DEL-IMS has the same indication for use as the predicate device. It shares the same<br>technological characteristics as the predicate device. Minor technological differences do not raise<br>any new questions regarding safety or effectiveness of the device. |
| Safety and<br>Effectiveness Information: | The device labeling contains operating instructions for safe and effective use of the DEL-IMS. The<br>software development for this device follows documented processes for software design,<br>verification and validation testing. Final device validation and risk assessment will be completed<br>prior to marketing, to identify potential design hazards that could cause an error or injury based on<br>the use of this device. Appropriate steps will be taken to control all identified risks. The device will<br>be tested for compliance to IEC 60601-1- 2 Medical Electrical Equipment Part 1: General<br>Requirements for Safety. |
| Conclusion: | The DEL-IMS performs the same functions in the same environment as the predict device<br>(DROC). It is as safe and effective as the predict device. We believe it does not introduce any new<br>potential safety risks and is substantially equivalent to the predict device. |

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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

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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 [phone] or [phone]

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

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## 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 | <div>✓</div> | 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 |