← Product Code [LLZ](/productcode/LLZ) · K980118 # KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER (K980118) _Eastman Kodak Company · LLZ · Mar 17, 1998 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K980118 ## Device Facts - **Applicant:** Eastman Kodak Company - **Product Code:** [LLZ](/productcode/LLZ.md) - **Decision Date:** Mar 17, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The KODAK Oncology Image manager (OIM) is a picture Archiving and Communications System (PACS) which acquires, communicates, stores, and displays images, including radiographic images and patient data connected with oncology treatment. ## Device Story KODAK Oncology Image Manager (OIM) functions as a PACS for oncology departments; archives patient information and images throughout cancer treatment. Inputs include diagnostic interfaces, networked interfaces, DICOM images, removable media, and digital cameras. System components include server, workcenter, review computer, touch screen monitor, CPU, film/document scanners, and CD-ROM writer/reader. Operates on Windows NT; supports Ethernet, Internet, and Intranet connectivity. Oncologists and nurses review consolidated images and patient data to monitor treatment progress. Output includes display on review monitors, CD, printers, and offline storage. Facilitates clinical decision-making by providing centralized access to patient records and radiographic images. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics PACS system; Windows NT operating system. Hardware: Server, workcenter, review computer, touch screen monitor, CPU, film/document scanners, CD-ROM writer/reader. Connectivity: Ethernet, Internet, Intranet. Data types: Image, text, patient information. Input sources: Diagnostic interface, networked interfaces, DICOM, removable media, digital cameras. Output: CD, printers, offline storage. ## Regulatory 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 - IMPAC, IMAGErt, IMAGE Management System ([K942346](/device/K942346.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 1980118 MAR 17 1998 ### DATE PREPARED: December 1, 1997 I. - SUBMITTER: II. Eastman Kodak Company Health Imaging Division 901 Elmgrove Road Rochester, New York 14653 - CONTACT PERSON: III. Nancy Butcher Regulatory Affairs (214) 454-1417 - DEVICE NAME: IV KODAK Oncology Image Manager (OIM) Trade Name #### DEVICE CLASSIFICATION V FDA has classified the predicate device as Regulatory Class II under 21 CFR 892.1750. - PREDICATE DEVICE: VI. IMPAC, IMAGErt, IMAGE Management System {1}------------------------------------------------ ### COMPARISON OF FEATURES: VII. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Characteristics | KODAK Digital Science
Oncology Image Manager | IMPAC, IMAGErt, Image
Management System | |---------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Knumber | this submission | K942346 | | GENERAL | | | | Advertised use | An acquisition, management,
distribution and archiving system,
PACS device. | A computerized image management
system. | | Hardware requirements | 90-132vac/47-63Hz
180-264vac/47-63Hz | 90-132vac/47-63Hz
180-264vac/47-63Hz | | Environmental | 4-45 degrees C/15-90% RH
non-condensing | 4-45 degrees C/15-90% RH
non-condensing | | Hardware Description | Server, Workcenter, Review Computer | Viewstations, Maintenance, Namer | | Network Capability | Ethernet, Internet, Intranet | Ethernet, Internet, Intranet | | Data Type | Image, Text, Patient Information | Image, Text, Patient Information | | Input Sources | Diagnostic interface, Networked
interfaces, DICOM images, Removable
media, Digital cameras | Diagnostic interface, Networked
interfaces, DICOM images,
Removable media | | Output Devices | CD, Printers, offline storage devices | CD, Printers, offline storage devices | | Operating System | Windows NT | PC Compatible | | Image Preview | yes | yes | | Open Case Preview | yes | yes | | Receive Images from
other systems | yes | yes | | Retrieve Images from
other systems | yes | yes | | Patient Demographic
Information | yes | yes | | Acquire Radiographic Films
from Film Digitizer | yes | yes | | Portable patient records | yes | yes | ﺴﺴﺴ ( દ દ {2}------------------------------------------------ #### DESCRIPTION OF DEVICE: VIII. KODAK Oncology Image Manager is designed to archive patient information and images gathered as the patient progresses through cancer treatment. The consolidated information and images can be reviewed as treatment progresses by onocologist and nurses.. ## IX. THE DEVICE The general hardware configuration of the KODAK Oncology Image Manager contains the following major components: -Touch screen Monitor -Central Processing Unit (CPU) -Film and Document scanners -CD-ROM writer and reader ## X. INDICATION FOR USE The KODAK Oncology Image manager (OIM) is a picture Archiving and Communications System (PACS) which acquires, communicates, stores, and displays images, including radiographic images and patient data connected with oncology treatment. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 7 1998 Nancv Butcher Regulatory Affairs Specialist Eastman Kodak Company Health Imaging Division 18325 Waterview Parkway Dallas. Texas 75252 Re: K980118 Kodak Digital Science Oncology Image Manager Dated: December 1, 1997 Received: January 13, 1998 Regulatory class: Unclassified Procode: 90 LLZ Dear Ms. Butcher: 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 (OS) for Medical Devices: General regulation (2) 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 vito 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) 594-639. 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/cdrf/dsmaldsmamain.html". Sincerely yours, Lillian Yin, Ph.D. Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K980118 510(k) Number (if known): Device Name: KODAK Oncology Image manager (OIM) INDICATION FOR USE: The KODAK Oncology Image Manager (OIM) a Picture Archiving and Communications System (PACS) which acquires, communicates, stores, and displays images, including radiographic images and patient data connected with oncology treatment. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDR., Office of Device Evaluation (ODE) Prescription Use (Per 21 CRF 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) 7 Jamil C. Wynn (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number K980118 --- **Source:** [https://fda.innolitics.com/device/K980118](https://fda.innolitics.com/device/K980118) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com