(73 days)
Not Found
No
The document mentions "AIQC (Automated Image Quality Control)" which is likely an automated process for quality control, not necessarily involving AI/ML in the modern sense. There is no mention of learning, training data, or complex algorithms typically associated with AI/ML in medical imaging.
No
The device is a laser imager primarily used for outputting hard copy images from various digital imaging sources for medical diagnosis, not for providing therapy.
No
The device is an imager that produces hard copy images from digital imaging source signals. It is used to present images for medical diagnosis but does not perform the diagnosis itself. It is a tool for outputting diagnostic images, not a diagnostic device.
No
The device is a laser imager with a mammography accessory, which is a hardware device that uses software for control and image management, but is not solely software.
Based on the provided text, the KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the KODAK DRYVIEW 8900 clearly states its purpose is to produce hard copy images from digital imaging source signals (like X-rays, CT scans, etc.). It is a device that outputs images generated by other medical imaging modalities, not a device that analyzes biological samples.
- The intended use and device description focus on processing and printing digital medical images for diagnostic purposes. There is no mention of analyzing biological specimens or providing information based on such analysis.
Therefore, the KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory falls under the category of a medical imaging output device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory's intended use is as a hard copy device for output from imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the 8900 and transformed optically to expose KODAK DRYVIEW imaging media. The system is intended for use with a variety of digital modalities, including, but not limited to CR, DR, CT, MR, Ultrasound, Nuclear Medicine, FFDM etc. for diagnostic use by medical radiologists and communications to referring physicians and their patients.
The KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory is intended to provide high-resolution hard copy images from digital imaging source output signals. The device is intended for use with KODAK DRYVIEW DVM film for use with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology) and FFDM (Full Field Digital mammography). The images are to be used for medical diagnosis medical and referring physicians and their patients.
Product codes
90 LMC
Device Description
The KODAK DRYVIEW 8900 Laser Imager Mammography Accessory's intended use is as a hard copy device for output from imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the 8900 and transformed optically to expose KODAK DRYVIEW imaging media. The system is intended for use with a variety of digital modalities, including, but not limited to CR, DR, CT, MR, Ultrasound, Nuclear Medicine, FFDM etc. for diagnostic use by medical radiologists and communications to referring physicians and their patients.
The subject device and predicate devices use the same technical design base. The printers receive image data from the modality. User control is performed directly by the modality or through the host control. KODAK DRYVIEW imaging media is removed from a daylight cartridge and transported to the laser imaging station. Image data and media merge at the laser station and the film is scanned. The exposed media is transported through the integrated processor and 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CR, DR, CT, MR, Ultrasound, Nuclear Medicine, FFDM
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical radiologists and communications to referring physicians and their patients.
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)
Safety and effectiveness are assured via meeting voluntary standards, including: DICOM, SMPTE, UL 60950, IEC 60601-1-1-1, IEC 60825-1, ISO 12207, and ISO 14971.
The subject device, like the predicate, has no patient contact. The devices also do not control, monitor or otherwise affect any devices directly connected to or affecting the patient. 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 DRYVIEW 8900 Laser Imager with Mammography Accessory and predicate device KODAK DRYVIEW 8610 Laser Imager for mammography 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. Both are high resolution printers with incorporated test patterns to assist in MQSA quality assurance testing.
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
FEB 2 0 2004
Image /page/0/Picture/1 description: The image shows the Kodak logo, which is a stylized letter 'K' in black on a white background. Below the logo, the text 'Section B1' is printed in a bold, sans-serif font. The text is aligned to the left and positioned directly under the logo.
K033821
Page 1 of 2
510(k) Summary
November 26, 2003
Contact: Stephen Slavens Eastman Kodak Company 1 Imation Way, 304-3B-61 343 State Street Oakdale, MN 55128 Rochester NY 14650 Phone: 651-393-1395 FAX: 651-393-1440
| Device: | |
|---|---|
| Trade name: | KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory |
| Common name: | Laser Printer |
| Classification name: | Medical Image Hardcopy Device 21 CFR 892.2040 |
| Predicate device: | Kodak DRYVIEW 8610 Laser Imager/ for Mammography (K002146) |
Description And Intended Use of Device:
The KODAK DRYVIEW 8900 Laser Imager Mammography Accessory's intended use is as a hard copy device for output from imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the 8900 and transformed optically to expose KODAK DRYVIEW imaging media. The system is intended for use with a variety of digital modalities, including, but not limited to CR, DR, CT, MR, Ultrasound, Nuclear Medicine, FFDM etc. for diagnostic use by medical radiologists and communications to referring physicians and their patients.
Technological Characteristics:
The subject device and predicate devices use the same technical design base. The printers receive image data from the modality. User control is performed directly by the modality or through the host control. KODAK DRYVIEW imaging media is removed from a daylight cartridge and transported to the laser imaging station. Image data and media merge at the laser station and the film is scanned. The exposed media is transported through the integrated processor and 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.
Image /page/0/Picture/12 description: The image shows the Kodak logo, which is the name "Kodak" in a bold, sans-serif font. Below the logo, it says "Official Imaging Sponsor of the Olympic Games." The Olympic rings are displayed below the text. There is also some handwritten text in the bottom right corner of the image.
1
K033821
Page 2 of 2
Performance Data:
Safety and effectiveness are assured via meeting voluntary standards, including: DICOM, SMPTE, UL 60950, IEC 60601-1-1-1, IEC 60825-1, ISO 12207, and ISO 14971.
Conclusion:
The subject device, like the predicate, has no patient contact. The devices also do not control, monitor or otherwise affect any devices directly connected to or affecting the patient. 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 DRYVIEW 8900 Laser Imager with Mammography Accessory and predicate device KODAK DRYVIEW 8610 Laser Imager for mammography 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. Both are high resolution printers with incorporated test patterns to assist in MQSA quality assurance testing.
Eastman Kodak therefore concludes that the KODAK DRYVIEW 8900 Laser Imager Mammography Accessory is as safe and effective as the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font. The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen Slavens Regulatory Affairs Director Eastman Kodak Health Imaging Group 1 Image Way 304-3B-61
Re: K033821
FEB 2 0 2004
Trade/Device Name: KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: 90 LMC Dated: December 4, 2003 Received: December 9, 2003
Dear Mr. Slavens:
OAKDALE MN 55127
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.
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 complics 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.
3
This letter will allow you to begin marketing your device as described in your Section 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Nancy C. Brogden
Nancy C. Brogdor Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
to proceed to the market.
4
Section B2
Statement of Indications for Use:
510(K) Number (if known)
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory
Indications for Use:
The KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory is intended to provide high-resolution hard copy images from digital imaging source output signals. The device is intended for use with KODAK DRYVIEW DVM film for use with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology) and FFDM (Full Field Digital mammography). The images are to be used for medical diagnosis medical and referring physicians and their patients.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | / | OR | Over the Counter |
|---|---|---|---|
| Use |
Nancy C Brogdon (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
| 510(k) Number | K033821 |
|---|---|
| --------------- | --------------------------------------------------------- |