DIGITAL PRINTER P6000D SERIES, MODEL P6000DU

K061302 · Mitsubishi Electric Corporation Kyoto Works · LMC · Jun 23, 2006 · Radiology

Device Facts

• Record ID: K061302
• Device Name: DIGITAL PRINTER P6000D SERIES, MODEL P6000DU
• Applicant: Mitsubishi Electric Corporation Kyoto Works
• Product Code: LMC · Radiology
• Decision Date: Jun 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2040
• Device Class: Class 2

Intended Use

Digital Printer P6000D series Model P6000DU receives signals from diagnostic imaging equipment or a personal computer, and automatically prints and ejects the received image data on the film/thermal paper. This device is not intended for mammography use.

Device Story

Digital Printer P6000D series Model P6000DU receives image data signals from diagnostic imaging equipment or personal computers; processes data via internal control unit; prints and ejects images onto 8x10" film or thermal paper. Used in clinical settings; operated by healthcare professionals. Device facilitates hardcopy documentation of diagnostic images for clinical review. Does not incorporate laser scanning.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Thermal printing process; 8x10" film/thermal paper output; control unit for image data processing. Complies with UL60601-1 and IEC60601-1-2 standards. No laser scanning unit.

Indications for Use

Indicated for printing and ejecting image data received from diagnostic imaging equipment or personal computers onto film or thermal paper. Not intended for mammography 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

• Drystar 5300M (K032635)

Submission Summary (Full Text)

{0}------------------------------------------------

K061302

# JUN 2 3 2006 510(k) Summary as required by 807.92

# 1. Company Identification

MITSUBISHI ELECTRIC CORPORATION KYOTO WORKS 1 Zusho Baba, Nagaokakyo city, Kyoto 617-8550

- 2. Contact Person
Aki Nakamura (Mr.), Manager VCP Engineering Group 1 Professional Electronics Department Tel: [phone] Fax: [phone]

- 3. Date of Submission
May 2, 2006

## 4. Establishment Registration No.

Not assigned yet

### 5. Device Trade name

Digital Printer P6000D series Model P6000DU

- 6. Common Name
Medical Image Hardcopy Device

- 7. Classification
Medical image hardcopy device was reviewed by the Radiology Panel and classified in Class Il per 21 CFR 892. 2040.

{1}------------------------------------------------

## 8. Product Code

LMC

#### 9. Description of Device

Digital Printer P6000D series Model P6000DU receives signals from diagnostic imaging equipment or a personal computer, and automatically prints and ejects the received image data on 8x10" sized film/thermal paper. It does not incorporate laser scanning unit. The control unit processes and controls image data and performs control of the whole device. This device is not intended for mammography use.

### 10. Intended Use

Digital Printer P6000D series Model P6000DU receives signals from diagnostic imaging equipment or a personal computer, and automatically prints and ejects the received image data on the film/thermal paper. This device is not intended for mammography use.

### 11. Compliance Standard

Digital Printer P6000D series Model P6000DU complies with the following standards-

UL60601-1 · Medical Electrical Equipment, Part 1: General Requirements for Safety IEC60601-1-2 - Medical electrical equipment - Part 1-2' General requirements for safety Collateral standard: Electromagnetic compatibility - Requirements and tests

#### 12. Predicate Device

Drystar 5300M manufactured by Agfa Corporation, 510(k) No .: K032635.

#### 13. Technological Characteristics

Digital Printer P6000D series Model P6000DU has same technological characteristics as Drystar 5300M. Model P6000DU uses a thermal process to produce medical images.

#### 14. Conclusion

Based on above mentioned items, it is concluded that Digital Printer P6000D series Model P6000DU is substantially equivalent to 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 features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined strands and a single wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

AUG - 3 2006

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Shinichi Yamanaka, Safety Department Mitsubishi Electric Corporation Satoru Kato, Senior Manager Professional Electric Department, Kyoto Works 1 Zusho Baba, Nagaokakyo City Kyoto 617-8550 JAPAN

Re: K061302

Trade/Device Name: Digital Printer P6000D series Model P6000DU Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: LMC Dated: May 8, 2006 Received: May 10, 2006

Dear Mr. Yamanaka:

This letter corrects our substantially equivalent letter of June 23, 2006.

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 (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

Image /page/2/Picture/12 description: The image is a circular logo with the letters "FDA" in a stylized font at the center. Above the letters, there is some text that is difficult to read due to the image quality. Below the letters, the word "Centennial" is written in a cursive font. The entire logo is surrounded by a dotted circle, and there is additional text along the perimeter of the circle, but it is also difficult to read.

*Protecting and Promoting Public Health*

{3}------------------------------------------------

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.

This letter will allow you to continue 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 [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 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 vours.

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

# Indications for Use

:

・・

510(k) Number (if known)

Device Name

Digital Printer P6000D series Model P6000DU

Indications For Use:

Digital Printer P6000D series Model P6000DU receives signals from diagnostic imaging equipment or a personal computer, and automatically prints and ejects the received image data on the film/thermal paper. This device is not intended for mammography use.

Prescription Use

(Pad 21 CFR 801 Subpart D)

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon
'Division Sign-Off

Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

Page 1 of _

3.