(83 days)
No
The description focuses on the device's function as a printer for medical images and reports, with no mention of AI or ML capabilities.
No
The device is described as a computer peripheral printing device used to make hard copies of medical images and reports, and there is no indication that it is used for therapy or treatment.
No.
The device is described as a "computer peripheral printing device" used to make hard copies of medical images and reports. Its function is solely to print images, not to provide any diagnostic information or analysis itself.
No
The device is described as a "computer peripheral printing device" and "imager," which are hardware components used to create hard copies of medical images. The description details physical characteristics like media size and supply trays, further indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are "computer peripheral printing devices used to make hard copy of medical images and reports on paper and/or film." This describes a function related to displaying or archiving medical images, not analyzing biological samples or providing diagnostic information based on in vitro tests.
- Device Description: The description reinforces that these are printers for medical images and reports.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely related to the output of existing medical images and reports.
N/A
Intended Use / Indications for Use
KODAK DIGITAL SCIENCE Distributed Medical Imagers are computer peripheral printing devices used to make hard copy of medical images and reports on paper and/or film.
Product codes
90 LMC
Device Description
KODAK DIGITAL SCIENCE 3600 Distributed Medical Imager is designed for mid to high end desktop Referral Imaging and Distributed Medical Imaging applications printing color or monochrome images on Medical Paper and/or Film Media up to 11x14 inch, with dual media supply trays and optional network interfacing.
KODAK DIGITAL SCIENCE 1200 Distributed Medical Imager is designed for low end to mid range desktop Referral Imaging and Distributed Medical Imaging applications printing color or monochrome images on Medical paper and/or film up to 8.5x11 inch, with a single media supply tray.
Accessories: Media & Inks
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Paper / 8.5x11 in.
- · KODAK DIGITAL SCIENCE Distributed Medical Imaging Paper / A4
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Paper / 4x6 in.
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Film / 8x10 in.
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Film / 11x14 in.
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Cartridge / Black 1
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Cartridge / Black 2
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Cartridge / Color 1
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Cartridge / Color 2
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Not Found
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
§ 892.2040 Medical image hardcopy device.
(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(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). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
JAN 25 1999
Appendix G -- Summary of Safety and Effectiveness
I. Date Prepared
October 30, 1998
II. Submitter
Eastman Kodak Company Health Imaging Division 343 State Street Rochester, New York 14650
III. Contact Person
Judith A. Wallace Regulatory Affairs (716) 724-2314
IV. Device Names
Trade Names: KODAK DIGITAL SCIENCE 3600 Distributed Medical Imager KODAK DIGITAL SCIENCE 1200 Distributed Medical Imager
Common Names: 3600 DMI; 3600 Imager 1200 DMI; 1200 Imager
V. Device Classification
FDA has classified the predicate device as Regulatory Class II under CFR 892.1750
VI. Predicate Device
KODAK EKTASCAN Medical Color Imager 2000PS ('KEMCI 2000'); 510(k) number K951948
VII. Description of Devices
KODAK DIGITAL SCIENCE 3600 Distributed Medical Imager is designed for mid to high end desktop Referral Imaging and Distributed Medical Imaging applications printing color or monochrome images on Medical Paper and/or Film Media up to 11x14 inch, with dual media supply trays and optional network interfacing.
KODAK DIGITAL SCIENCE 1200 Distributed Medical Imager is designed for low end to mid range desktop Referral Imaging and Distributed Medical
1
Imaging applications printing color or monochrome images on Medical paper and/or film up to 8.5x11 inch, with a single media supply tray.
Accessories: Media & Inks
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Paper / 8.5x11 in.
- · KODAK DIGITAL SCIENCE Distributed Medical Imaging Paper / A4
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Paper / 4x6 in.
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Film / 8x10 in.
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Film / 11x14 in.
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Cartridge / Black 1
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Cartridge / Black 2
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Cartridge / Color 1
- KODAK DIGITAL SCIENCE Distributed Medical Imaging Cartridge / Color 2
VIII. Indications for Use
KODAK DIGITAL SCIENCE Distributed Medical Imagers are computer peripheral printing devices used to make hard copy of medical images and reports on paper and/or film.
IX. Substantial Equivalence:
The purpose and functionality of the KODAK DIGITAL SCIENCE Distributed Medical Imagers is substantially equivalent to the KODAK EKTASCAN Medical Color Imager 2000PS. The basis for the equivalence is that the 3600 and 1200 Imagers, like the KEMCI 2000PS, are computer peripheral printing devices which print monochrome or color images on paper or transparency media. The primary difference is that the 3600 and 1200 Imagers directly deposit black or color inks onto the receiving media to render the image whereas the KEMCI 2000PS uses heat to transfer black or color dyes from a substrate material onto the receiving media.
Although technologically different, the function and output of the SE devices is similar to that of the predicate device and we conclude that the SE devices are as safe and effective as the predicate device.
| Specification | KODAK DIGITAL SCIENCE
3600 Distributed Medical
Imager | KODAK DIGITAL SCIENCE
1200 Distributed Medical
Imager | KODAK EKTASCAN
Medical Color Imager
2000PS |
|-----------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Printing Method | Inkjet | Inkjet | Thermal Dye Sublimation |
| Interfaces | Parallel: IEEE 1284
Optional: Ethernet,
10Base2 RJ45 | Parallel: IEEE 1284 | Parallel: IEEE 1284
Optional: Ethernet,
10Base2 RJ45
SCSI (2 ports) |
| Standards | UL, CSA, FCC, EN50082,
CISPR 22, VCCI, CE Mark,
C-Tick, Energy Star, SETI
Mark, SEMKO | UL, CSA, FCC, EN50082,
CISPR 22, VCCI, CE Mark,
C-Tick, Energy Star | UL, CSA, TUV-GS, FCC,
ICES, EN500, VCCI, CE
Mark |
| Sheet Sizes | A3 (11.69x16.54 in.)
Tabloid (11x17 in.)
11x14 in.
8x10 in. | 8x10 in.
Letter
Legal
A4 | 8.5x11.0 in.
8.5x11.7 in.
8.5x14.0 in.
9.5x14.0 in. |
Tabular Comparison of Features and Specifications of the Devices:
2
| | Letter
Legal
A4
Executive
B5
A5
Custom:
3x5 in. min.
12.6x22 in. max. | Executive
B5
A5
A6 | |
|---------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------|
| Print Media | Coated Paper
Transparency (blue)
Plain Paper
Card Stock | Coated Paper
Transparency (blue)
Plain Paper
Card Stock | Coated Paper
Transparency (clear) |
| Media Supplies | 1 or 2 | 1 | 1 |
| Monochrome Printing | Yes | Yes | Yes |
| Color Printing | Yes | Yes | Yes |
| Print Resolution | 1200 dots per inch | 1200 dots per inch | 300 pixels per inch |
| Hard Drive | optional | none | none |
| Memory | 8-64 MB RAM | n/a | 48 MB RAM |
$$\begin{array}{c} \text{G}^{\text{'}} \text{3} \ \text{10/30/98} \end{array}$$
3
Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is black and the background is white. The text is centered in the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 25 1999
Judith A. Wallace Regulatory Affairs Associate Eastman Kodak Company Health Imaging Division 901 Elmgrove Road Rochester. NY 14653
Re:
K983905 Kodak Digital Science 1200 & 3600 Distributed Medical Imagers Dated: October 30, 1998 Received: November 3, 1998 Regulatory class: II 21 CFR 892.2040/Procode: 90 LMC
Dear Ms. Wallace:
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). 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 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) 594-4613. 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 requlation 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Facsimile of CDRH's "Indication for Use" Page 3.
510(k) Number (if known): K983905
Device Name:
KODAK DIGITAL SCIENCE 3600 Distributed Medical Imager KODAK DIGITAL SCIENCE 1200 Distributed Medical Imager
Indication of Use:
KODAK DIGITAL SCIENCE Distributed Medical Imagers are computer peripheral printing devices used to make hard copy of medical images and reports on paper and/or film.
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT
Concurrence of CDRH, Office of Device Evaluation
and Radiological Devices
510(k) Number K983905
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter _