IIRAD DIRECTRAY OPERATOR CONSOLE

{0}------------------------------------------------ JUN - 8 1998 Image /page/0/Picture/1 description: The image shows the text "K986970" at the top. Below that is the word "STERLING" in large, bold letters with a line underneath. Underneath that is the text "Diagnostic Imaging" in a smaller font. Image /page/0/Picture/2 description: The image shows a vertical, rectangular shape with a white, curved line running through the center. The background of the rectangle is black. The white line starts at the bottom left corner, curves towards the right, and then curves back to the left as it reaches the top right corner. ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | SUBMITTED BY: | Jean E. Bartlett<br>Regulatory Affairs<br>STERLING DIAGNOSTIC IMAGING, INC.<br>PO Box 19048, Mail Drop 102<br>Greenville, SC 29602-9048 | | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--| | PREPARATION DATE: | March 13, 1998 | | | DEVICE NAME: | DirectRay™ Operator Console<br>Two versions: (a) Parallel | | There are two versions of the device covered by this premarket notification, the Parallel version and the Integrated version, and the classification information is slightly different for the two versions: (b) Integrated ## CLASSIFICATION and PROCODE: | Parallel: | 21CFR 892.2050 (Proposed)- PACS Device (90 LMD)<br>and accessory to:<br>Unclassified - Solid-State Digital X-Ray Device(90MQB) | |-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Integrated: | 21CFR 892.2050 (Proposed) - PACS Device (90 LMD)<br>21CFR 892.1680 -Stationary X-Ray System (90KPR)<br>and accessory to:<br>Unclassified - Solid-State Digital X-Ray Device(90MQB) | PREDICATE DEVICES: In both versions, the DROC is an accessory to the DirectRay™ digital image capture device (K#973206). LINX™ Networking System - K964250 Parallel: MicroX-80 HF - K944149 Integrated: (X-ray console functions only) > Sterling Diagnostic Imaging, Inc. 10 South Academy Street P.O. Box 19545 Greenville, SC 29602-0248 36 {1}------------------------------------------------ DEVICE DESCRIPTION: The DirectRay™ Operator Console is that device, which when used with any X-ray generating equipment and the DirectRay™ device (Sterling Diagnostic Imaging Direct Radiography™ ' K#973206) allows the synchronization of the ready states of the DirectRay™ device and the X-ray generator, and allows the operator to acquire, preview and transmit image and associated text data along with exam administration report capabilities. In one version, this device will also integrate these functions with the typical functions of an X-ray console eliminating the need for a separate X-ray console. This device is located in the control booth and will usually be housed in a specially designed cabinet. An optional feature of the DROC is the ability to link the digital image with the hospital information/radiology information systems (HIS/RIS). INTENDED USE: To provide a network connection to various output (e.g. hardcopy, softcopy and archive) devices from any radiographic device which uses the DirectRay™ Image capture system. To synchronize the ready states of the DirectRay™ 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. COMPARISON TO PREDICATE DEVICE(s): The DROC brings together the features of the LINX™ Networking System and the X-ray console functions of the Micro X-80 into a single device. With respect to the synchronization of the ready states of the DirectRay™ device and the radiographic equipment, the DROC is considered an accessory to the DirectRay™. Signature JardBartlett Date March 13, 1998 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the central design. The text is in a simple, sans-serif font. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN - 8 1998 Jean E. Bartlett Regulatory Affairs Manager Sterling Diagnostic Imaging 10 South Academy Street Mailbox 120 P.O. Box 19048 Greenville, SC 29602-9048 Re: K980970 iiRAD™ Operator Console Dated: March 13, 1998 Received: March 16, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ Dear Ms. Bartlett: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdr/dsmaldsmam.html". Sincerely yours, Zillian Yi Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## INDICATIONS STATEMENT 510(k) Number (if known): __ K 9.30970 Device Name: DirectRay™ Operator Console Indications for Use: The DirectRay™ Operator Console has application whenever the transmission of radiographic images and associated patient text data is desired to take place from an input device, such as any radiographic equipment which uses the DirectRay™ device, to any output device, such as hardcopy, softcopy, or archive devices. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use (Per 21 CFR 801.109) | ✓ | |---------------------------------------|---| | OR Over-The-Counter | | (Optional Format 1-2-96) David C. Severson (Division Sign-Off) Division of Reproductive, Abdominal, B and Radiological Dev 510(k) Number 39