(47 days)
Not Found
No
The document describes a thermal printer for medical images and does not mention any AI or ML capabilities.
No
The device is a printer for diagnostic images and is not involved in treating or diagnosing a medical condition.
No
The device is a thermal printer intended for printing diagnostic images, not for performing diagnosis itself. It is explicitly described as a "general purpose thermal printer" and an "accessory" to medical imaging systems.
No
The device is described as a "thermal printer" and "digital film imager," which are hardware components. It is intended to print images, a physical output. While it connects to a network and receives digital data, its primary function is a physical process performed by hardware.
Based on the provided information, the Sony UP-DF500 FilmStation™ Digital Film Imager is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that this device is a thermal printer used to print diagnostic images from medical imaging systems (like CT and MRI). It does not interact with or analyze biological samples.
- The device's function is printing images. Its purpose is to create a physical copy of a digital image for review, not to perform any diagnostic test or analysis on a biological sample.
The device is a medical device, specifically a medical image printer, but it falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Sony UP-DF500 FilmStation™ Digital Film Imager is a thermal printer intended for use in printing high-resolution diagnostic images from CT, MRI or other compatible medical imaging systems. The Sony UP-DF500 is intended for use by medical radiologists or other appropriately trained medical personnel.
Product codes
LMC
Device Description
The Sony UP-DF500 FilmStation™ Digital Film Imager is a general purpose thermal printer and is intended for use as an accessory to a wide variety of medical imaging systems for digitally printing black and white still images with DICOM format. The Sony UP-DF500 is connected to a DICOM network and the image from a compatible medical imaging system is transmitted via the DICOM network.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI or other compatible medical imaging systems.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical radiologists or other appropriately trained medical personnel.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K010275, K021054, K962967, K002146
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
KO2 41 08
510(k) Summary
FEB 0 4 2003
for
Sony UP-DF500 FilmStation™ Digital Film Imager
1. Sponsor
Sony Medical Systems Division Sony Electronics Inc. 1 Sony Drive Park Ridge, NJ 07656
Contact Person: Mr. Anthony John Kefalos Phone Number: 201-358-4330
Date Prepared: December 18, 2002
2. Device Name
| Proprietary Name: | UP-DF500 FilmStation™ Digital Film Imager |
|---|---|
| Common/Usual Name: | Thermal Printer/Imager |
| Classification Name: | Medical Image Hardcopy Device |
Predicate Devices 3.
- Agfa Drystar 4500 Printer . Agfa Medical Imaging K010275
- Codonics Horizon Series Medical Multimedia Dry Imagers . Codonics, Inc. K021054
- Fuji Medical Dry Imager FM-DP 2636 ● Fuji Medical Systems USA, Inc. K962967
- KODAK DRY VIEW 8610 Laser Imager ● Eastman Kodak Company K002146
1
4. Device Description
The Sony UP-DF500 FilmStation™ Digital Film Imager is a general purpose thermal printer and is intended for use as an accessory to a wide variety of medical imaging systems for digitally printing black and white still images with DICOM format. The Sony UP-DF500 is connected to a DICOM network and the image from a compatible medical imaging system is transmitted via the DICOM network.
న. Intended Use
The Sony UP-DF500 FilmStation™ Digital Film Imager is a thermal printer intended for use in printing high-resolution diagnostic images from CT, MRI or other compatible medical imaging systems. The Sony UP-DF500 is intended for use by medical radiologists or other appropriately trained medical personnel.
Technological Characteristics and Substantial Equivalence 6.
The Sony UP-DF500 FilmStation™ Digital Film Imager has the same overall purpose and function as the predicate devices cited above. All of the systems are intended to print a high-resolution, hard copy of an image generated by a medical imaging system. The printed images can be used for medical diagnostic purposes.
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three curved lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sony Electronics, Inc. % Cynthia A. Sinclair, RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760 Re: K024188 Trade/Device Name: Sony UP-DF500 FilmStation™ Digital Film Imager Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: 90 LMC Dated: December 18, 2002 Received: December 19, 2002
Dear Ms. Sinclair:
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 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.
FEB 0 4 2003
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 to proceed to the market.
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. Brogdon
Nancy C. Brogdon Director. Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
510(k) Number (if known): K 82 4188
Device Name: ___Sony UP-DF500 FilmStation™ Digital Film Imager
Indications for Use:
The Sony UP-DF500 FilmStation™ Digital Film Imager is a thermal printer intended for use in printing high-resolution diagnostic images from CT, MRI or other compatible medical imaging systems. The Sony UP-DF500 is intended for use by medical radiologists or other appropriately trained medical personnel.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Hanson
510(k) Nur
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Sony Medical Systems Division 510(k) December 18, 2002 UP-DF500 FilmStation™ Digital Film Imager
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