(63 days)
Not Found
No
The summary describes a standard PACS system for oncology, focusing on archiving, communication, storage, and display of images and data. There is no mention of AI, ML, or any advanced image processing that would typically indicate the use of such technologies. The description of the hardware and function aligns with traditional PACS capabilities.
No
The device is a Picture Archiving and Communications System (PACS) for managing oncology images and patient data, which is used for review by oncologists and nurses; it does not directly treat or diagnose conditions.
No
The KODAK Oncology Image Manager (OIM) is described as a Picture Archiving and Communications System (PACS) that acquires, communicates, stores, and displays images and patient data for oncology treatment. Its purpose is to archive information for review by oncologists and nurses as treatment progresses. It does not perform analysis or interpretation of images to diagnose conditions.
No
The device description explicitly lists hardware components (Touch screen Monitor, CPU, Film and Document scanners, CD-ROM writer and reader) as part of the general hardware configuration.
Based on the provided information, the KODAK Oncology Image Manager (OIM) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a PACS system for acquiring, communicating, storing, and displaying images and patient data related to oncology treatment. This is focused on managing and reviewing medical images and associated patient information, not on performing tests on biological samples to diagnose or monitor a condition.
- Device Description: The description details the hardware components and the function of archiving and reviewing images and patient information. There is no mention of analyzing biological samples or performing any kind of in vitro test.
- Lack of IVD Characteristics: IVD devices typically involve reagents, assays, or other components used to test biological specimens (like blood, urine, tissue) outside of the body. The KODAK OIM does not describe any such components or processes.
The KODAK OIM is a medical device, specifically a Picture Archiving and Communication System (PACS), used for managing medical images and related data within a clinical setting. Its function is to support the workflow of oncologists and nurses by providing access to patient information and images, not to perform diagnostic tests on biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
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.
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
Oncologist and nurses
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 |
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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:
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