KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600

K983905 · Eastman Kodak Company · LMC · Jan 25, 1999 · Radiology

Device Facts

• Record ID: K983905
• Device Name: KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600
• Applicant: Eastman Kodak Company
• Product Code: LMC · Radiology
• Decision Date: Jan 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2040
• Device Class: Class 2

Intended 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.

Device Story

KODAK DIGITAL SCIENCE 3600 and 1200 Distributed Medical Imagers are desktop computer peripheral printing devices; used in referral imaging and distributed medical imaging applications. Devices accept digital medical image data from connected computer systems; transform data into hard copy output via inkjet printing technology. 3600 model supports up to 11x14 inch media with dual supply trays; 1200 model supports up to 8.5x11 inch media with single supply tray. Operated by clinical staff in medical environments. Output provides clinicians with physical copies of medical images and reports for diagnostic review and patient records. Benefits include distributed access to high-resolution medical hard copies.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Inkjet printing technology; IEEE 1284 parallel interface (optional Ethernet/10Base2 RJ45 for 3600). 3600 model: 11x14 inch max media, dual trays, 8-64 MB RAM, optional hard drive. 1200 model: 8.5x11 inch max media, single tray. Print resolution 1200 dpi. Standards: UL, CSA, FCC, EN50082, CISPR 22, VCCI, CE Mark, C-Tick, Energy Star.

Indications for Use

Indicated for use as a computer peripheral printing device to produce hard copies of medical images and reports on paper or film for clinical use.

Regulatory Classification

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.

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). 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.

Predicate Devices

• KODAK EKTASCAN Medical Color Imager 2000PS (K951948)

Submission Summary (Full Text)

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K983905

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 [phone]

### 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

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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<br>3600 Distributed Medical<br>Imager | KODAK DIGITAL SCIENCE<br>1200 Distributed Medical<br>Imager | KODAK EKTASCAN<br>Medical Color Imager<br>2000PS |
|-----------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Printing Method | Inkjet | Inkjet | Thermal Dye Sublimation |
| Interfaces | Parallel: IEEE 1284<br>Optional: Ethernet,<br>10Base2 RJ45 | Parallel: IEEE 1284 | Parallel: IEEE 1284<br>Optional: Ethernet,<br>10Base2 RJ45<br>SCSI (2 ports) |
| Standards | UL, CSA, FCC, EN50082,<br>CISPR 22, VCCI, CE Mark,<br>C-Tick, Energy Star, SETI<br>Mark, SEMKO | UL, CSA, FCC, EN50082,<br>CISPR 22, VCCI, CE Mark,<br>C-Tick, Energy Star | UL, CSA, TUV-GS, FCC,<br>ICES, EN500, VCCI, CE<br>Mark |
| Sheet Sizes | A3 (11.69x16.54 in.)<br>Tabloid (11x17 in.)<br>11x14 in.<br>8x10 in. | 8x10 in.<br>Letter<br>Legal<br>A4 | 8.5x11.0 in.<br>8.5x11.7 in.<br>8.5x14.0 in.<br>9.5x14.0 in. |

Tabular Comparison of Features and Specifications of the Devices:

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| | Letter<br>Legal<br>A4<br>Executive<br>B5<br>A5<br>Custom:<br>3x5 in. min.<br>12.6x22 in. max. | Executive<br>B5<br>A5<br>A6 | |
|---------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------|
| Print Media | Coated Paper<br>Transparency (blue)<br>Plain Paper<br>Card Stock | Coated Paper<br>Transparency (blue)<br>Plain Paper<br>Card Stock | Coated Paper<br>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 |

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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#### 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 ***_***