(30 days)
Not Found
No
The summary describes a system for digitizing, processing, viewing, and transmitting medical images using standard DICOM protocols. There is no mention of AI, ML, or any related concepts like training sets, test sets, or performance metrics typically associated with AI/ML algorithms. The image processing mentioned appears to be standard adjustments and annotations, not AI-driven analysis.
No
This device is software for digitizing and managing radiological images, not for treating diseases or conditions.
No
The device is described as a "radiological digitization application" that captures, processes, views, and transmits DICOM images for printing, archiving, or display. Its primary function is to digitize computed radiography exposed phosphor plates. It does not state that it interprets or analyzes these images to provide a medical diagnosis, only that it handles the images.
No
The description explicitly states the device "utilizes a scanner and software interface to digitize computed radiography exposed phosphor plates," indicating a hardware component (the scanner) is integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Kodak Radiation Oncology Software / for ACR systems is described as a radiological digitization application that processes and manages medical images obtained from computed radiography exposed phosphor plates. It deals with images of the body, not with analyzing biological specimens.
- Intended Use: The intended use clearly states it's for digitizing and managing radiological images for purposes like localization, verification, and simulation in radiation oncology. This is a diagnostic imaging workflow, not an in vitro diagnostic process.
The device's function is centered around image acquisition, processing, and management within a radiological context, which is distinct from the analysis of biological samples that defines an IVD.
N/A
Intended Use / Indications for Use
Kodak Radiation Oncology Software / for ACR systems is intended to utilize a scanner and software interface to digitize computed radiography exposed phosphor plates.
Kodak Radiation Oncology Software / for ACR systems is DICOM 3.0 compliant radiological digitization application.
Kodak Radiation Oncology Software / for ACR systems enables the user to autoarchive lossless or lossy compressed images locally or at a remote archive site. Supports DICOM 3.0 Query and Retrieve Service Class.
Product codes
90 LLZ
Device Description
The Kodak Radiation Oncology Software / for ACR systems enables digitization of computed radiography exposed phosphor plates for acquiring portal (localization and verification) images and simulation images. The device enables capture, processing, viewing and transmission of DICOM 3.0 compliant images for printing, archiving or display. Image review tools are included that enable the user to adjust, magnify, and annotate the images.
The Kodak Radiation Oncology Software / for ACR systems is dedicated specifically for use with Kodak ACR products.
Kodak Radiation Oncology Software / for ACR systems utilizes a scanner and software interface to digitize computed radiography exposed phosphor plates.
Kodak Radiation Oncology Software / for ACR systems is DICOM 3.0 compliant radiological digitization application.
Kodak Radiation Oncology Software / for ACR systems is enables the user to auto-archive lossless or lossy compressed images locally or at a remote archive site. Supports DICOM 3.0 Query and Retrieve Service Class
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Radiography (CR)
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)
The information presented in the pre-market notification demonstrates that the performance of the Kodak Radiation Oncology Software is substantially equivalent to the cleared predicate device and provides a reasonable assurance that the Kodak Radiation Oncology Software is safe and effective for the stated intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Attachment 6
510(k) Summary
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.
The assigned 510(k) number is: _ Ke بج ك د 2 / 2
-
Eastman Kodak Company. 1. Submitter name, 343 State Street address, Rochester, New York 14650 contact (716) 724-4795
Contact Person: Anne Zavertnik -
Date 510(k) prepared: July 10, 2001 2. Preparation date
-
Kodak Radiation Oncology Software / for ACR Trade or Proprietary Name: 3. Device name systems DICOM Client Common Name: PACS under 21 CFR 892.2050 Classification Name:
-
The Kodak Radiation Oncology Software is substantially equivalent to the DI-4. Predicate 2000 DICOM Client (K980213, March 17, 1998), formerly owned by device Lumisys, Inc.
Continued on next page
1
510(k) Summary, Continued
The Kodak Radiation Oncology Software / for ACR systems enables 5. Device description digitization of computed radiography exposed phosphor plates for acquiring portal (localization and verification) images and simulation images. The device enables capture, processing, viewing and transmission of DICOM 3.0 compliant images for printing, archiving or display. Image review tools are included that enable the user to adjust, magnify, and annotate the images.
The Kodak Radiation Oncology Software / for ACR systems is dedicated specifically for use with Kodak ACR products.
- Device Kodak Radiation Oncology Software / for ACR systems utilizes a scanner and intended software interface to digitize computed radiography exposed phosphor plates. use
Kodak Radiation Oncology Software / for ACR systems is DICOM 3.0 compliant radiological digitization application.
Kodak Radiation Oncology Software / for ACR systems is enables the user to autoarchive lossless or lossy compressed images locally or at a remote archive site. Supports DICOM 3.0 Query and Retrieve Service Class
- Comparison The intended use of the Kodak Radiation Oncology Software is the same as to predicate the intended use as previously cleared for DI-2000 DICOM CLIENT device software, (K980213, March 17, 1998), in that it supports digitization of phosphor plates exposed in computed radiography. The Kodak Radiation Oncology Software narrows the focus from the general radiology applications to radiation therapy applications. While the Kodak Radiation Oncology Software enables the digitization of phosphor plates, it will not enable digitization of radiology films on film digitizers as the DI-2000 DICOM CLIENT does.
Table 1 lists a comparison of characteristics of the Kodak Radiation Oncology Software and the predicate device.
Continued on next page
2
510(k) Summary, Continued
- Comparison Table 1 7. to predicate device. Continued
| Feature | Kodak Radiation
Oncology Software | Predicate
device |
|---------------------------------------------------------------------|--------------------------------------|---------------------|
| Acquires portal localization,
verification and simulation images | Y | N |
| Patient Information modification | Y | Y |
| Delete Patient Information | Y | Y |
| Annotate DICOM images | Y | N |
| Automatic and dynamic window
and level controls | Y | Y |
| Automatic output of DICOM 3.0
images | Y | Y |
| Group send to multiple locations | Y | Y |
| Supports full 12 bit grayscale data | Y | Y |
| Image Flip | Y | Y |
| Image rotation | Y | Y |
| JPEG Lossless, Lossy, Enhanced
compression | Y | Y |
| Print DICOM Image | Y | Y |
| Windows Print | Y | Y |
| Quality Assurance function | Y | Y |
| LAN/WAN Communication | Y | Y |
-
- Conclusions The information presented in the pre-market notification demonstrates that the performance of the Kodak Radiation Oncology Software is substantially equivalent to the cleared predicate device and provides a reasonable assurance that the Kodak Radiation Oncology Software is safe and effective for the stated intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 2001
Ms. Anne Zavertnik Regulatory Affairs Manager Eastman Kodak Company 343 State Street ROCHESTER NEW YORK 14650 Re: K012155
Kodak Radiation Oncology Software for ACR Systems Dated: July 10, 2001 Received: July 11, 2001 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Ms. Zavertnik:
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 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). 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 (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 531 through 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) 594-4639. 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" (21CFR 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/cdrh/dsma/dsmamain.html".
Sincerely vours
Nancy C. Brogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
4
Attachment 1
Statement of Intended Use
.. . . . . . . . . . . . . . . . . . . .
| Page 1 of 1 | |
|---|---|
| 510(k) Number (if known): | K012155 |
| Device Name: | Kodak Radiation Oncology Software / for ACR systems |
| Indications for Use: | Kodak Radiation Oncology Software / for ACR systems is intended to utilize a scanner and software interface to digitize computed radiography exposed phosphor plates. |
| Kodak Radiation Oncology Software / for ACR systems is DICOM 3.0 compliant radiological digitization application. | |
| Kodak Radiation Oncology Software / for ACR systems enables the user to autoarchive lossless or lossy compressed images locally or at a remote archive site. Supports DICOM 3.0 Query and Retrieve Service Class. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ... . . .. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Nancy C. brigdon | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| Prescription Use | |
| 510(k) Number | K012155 |
| OR | |
| Over-The-Counter Use |
(Per 21 CFR 801.109)
(Optional Format 1-2-96)Eastman Kodak Company Kodak Radiation Oncology Software
(Optional Format 1-2-96)