(45 days)
The KODAK Medical Imager 300 Imager is intended use as a hard copy device for output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the Medical Imager 300 and transformed thermally to develop Eastman Kodak imaging media. The system of printer and physical image is intended for use with a variety of modalities, including, but not limited to CR, DR, CT, MRI, Ultrasound, Nuclear Medicine, etc. for diagnostic use by medical radiologists and communications to referring physicians and their patients. The system of printer and physical image is not a high resolution device and is not intended for use with FFDM systems.
The imagers receive image data from the modality. User control is performed directly by the modality or through the host control. KODAK imaging media is removed from a cartridge and transported to the imaging station. Image data addresses the individual pixel elements in the thermal print head. The heat of the thermal head reacts the thermally sensitive film to produce the image and the film exits the printer. Software is used to control the image management and machine functions. AIQC (Automated Image Quality Control) matches printing power with film characteristics to provide consistently high image quality.
The provided text focuses on the 510(k) summary for the KODAK Medical Imager 300 Thermal Printer, which is a hardcopy device for medical images. It primarily discusses the device's intended use, technological characteristics, and its substantial equivalence to a predicate device based on safety standards.
Crucially, the document does NOT contain information about acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test sets, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance.
The "Performance Data" section merely states: "Safety and effectiveness are assured via meeting voluntary standards, including: DICOM, SMPTE, UL 2601-1, IEC 60601-1, ISO 12207 and ISO 14971." This refers to compliance with general industry and safety standards for medical devices, not specific diagnostic performance metrics or a study demonstrating clinical accuracy.
Therefore, I cannot fulfill your request for the detailed table and study information as the provided text lacks this content. The device described is a thermal printer, which outputs images, and its performance is assessed in terms of image quality consistency and safety compliance, rather than diagnostic accuracy metrics typically associated with AI/CAD devices.
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SEP 2 4 2004
Section B1
510(k) Summary
August 5, 2004
Eastman Kodak Company 343 State Street Rochester NY 14650
Contact: Stephen Slavens 1 Imation Way, 304-3B-61 Oakdale, MN 55128 Phone: 651-393-1395 FAX: 651-393-1440
Device:
Trade name: Common name: Classification name: KODAK Medical Imager 300 Thermal Printer Medical Image Hardcopy Device 21 CFR 892.2040
Predicate device:
Kodak DRYVIEW 8100 (K972163)
Intended Use of Device
The KODAK Medical Imager 300 Imager is intended use as a hard copy device for output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the Medical Imager 300 and transformed thermally to develop Eastman Kodak imaging media. The system of printer and physical image is intended for use with a variety of modalities, including, but not limited to CR, DR, CT, MRI, Ultrasound, Nuclear Medicine, etc. for diagnostic use by medical radiologists and communications to referring physicians and their patients.
Technological Characteristics:
The subject device and predicate devices use similar technology to create diagnostic films. The imagers receive image data from the modality. User control is performed directly by the modality or through the host control. KODAK imaging media is removed from a cartridge and transported to the imaging station. Image data addresses the individual pixel elements in the thermal print head. The heat of the thermal head reacts the thermally sensitive film to produce the image and the film exits the printer.
Software is used to control the image management and machine functions. AIQC (Automated Image Quality Control) matches printing power with film characteristics to provide consistently high image quality.
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Performance Data:
Safety and effectiveness are assured via meeting voluntary standards, including: DICOM, SMPTE, UL 2601-1, IEC 60601-1, ISO 12207 and ISO 14971.
Conclusion:
The devices use different means to conform with electrical safety, but present any different safety issues. Medical personnel review images displayed by the subject device and its predicates. This offers ample opportunity for competent human intervention in case of a malfunction or other failure.
The subject KODAK Medical Imager 300 and predicate device KODAK DRYVIEW 8100 Laser I no our have both been designed to the equivalent safety standards. As with this predicate device, a test pattern generator and automatic image quality control (AIQC) system are incorporated to assure consistency between input signals and output density.
Eastman Kodak therefore concludes that the KODAK Medical Imager 300 is as safe and effective as the predicate device.
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. Inside the circle is a stylized eagle-like symbol with three curved lines representing its wings. The seal appears to be a government emblem, likely representing the U.S. Department of Health and Human Services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen Slavens Regulatory Affairs Director Eastman Kodak Company Health Imaging Group, Digital Output SPG 1 Imation Wav. 304-3B-61 OAKDALE MN 55128-3414
Re: K042158 Trade/Device Name: KODAK Medical Imager 300 Thermal Printer Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: 90 LMC Dated: August 5, 2004
Received: August 10, 2004
Dear Mr. Slavens:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.
SEP 2 4 2004
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ough manies of substantial equivalence of your device to a legally promatication. The PDF intelligence of thems to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please It you desire specific advice to: your Gentle of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 10. questions on 1301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Obmphanoo as (socification" (21CFR Part 807.97) you may obtain. Other general by relerenos to promative notificant under the Act may be obtained from the Division of Small miorination on your responsional Consumer Assistance at its toll-free number (800) 638-2041 or 14andfacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Section B2
Statement of Indications for Use:
510(K) Number (if known): 长 (04 乙| 5 8
Device Name: KODAK Medical Imager 300 Thermal Printer
Indications for Use:
The KODAK Medical Imager 300 Imager is intended use as a hard copy device for output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the Medical Imager 300 and transformed thermally to develop Eastman Kodak imaging media. The system of printer and physical image is intended for use with a variety of modalities, including, but not limited to CR, DR, CT, MRI, u variety of nodalines, etc. for diagnostic use by medical radiologists and Creasound, Fractering physicians and their patients. The system of printer and physical image is not a high resolution device and is not intended for use with FFDM systems.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| OR Over the Counter Use | ____________________ |
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K042158 |
|---|---|
| --------------- | --------- |
§ 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.