UP-DF500 FILMSTATION DIGITAL FILM IMAGER

K024188 · Sony Medical Systems · LMC · Feb 4, 2003 · Radiology

Device Facts

• Record ID: K024188
• Device Name: UP-DF500 FILMSTATION DIGITAL FILM IMAGER
• Applicant: Sony Medical Systems
• Product Code: LMC · Radiology
• Decision Date: Feb 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2040
• Device Class: Class 2

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.

Device Story

Sony UP-DF500 FilmStation is a thermal printer for medical imaging. Device connects to DICOM networks to receive black and white still images from compatible imaging systems (CT, MRI). Operates in clinical environments; used by radiologists or trained medical personnel. Transforms digital DICOM inputs into high-resolution hardcopy diagnostic film. Output used by clinicians for medical diagnostic purposes; facilitates clinical decision-making by providing physical film records of diagnostic images.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Thermal printer; DICOM network connectivity; produces black and white hardcopy diagnostic film. Class II medical image hardcopy device.

Indications for Use

Indicated for printing high-resolution diagnostic images from CT, MRI, or other compatible medical imaging systems. Intended for use by radiologists or trained medical personnel.

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

• Agfa Drystar 4500 Printer (K010275)
• Codonics Horizon Series Medical Multimedia Dry Imagers (K021054)
• Fuji Medical Dry Imager FM-DP 2636 (K962967)
• KODAK DRY VIEW 8610 Laser Imager (K002146)

Submission Summary (Full Text)

{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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

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

Page vi