KONICA LASER IMAGER, MODEL DRYPRO MODEL 771

K032681 · Konica Medical and Graphic Corporation · LMC · Sep 24, 2003 · Radiology

Device Facts

• Record ID: K032681
• Device Name: KONICA LASER IMAGER, MODEL DRYPRO MODEL 771
• Applicant: Konica Medical and Graphic Corporation
• Product Code: LMC · Radiology
• Decision Date: Sep 24, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2040
• Device Class: Class 2

Intended Use

The Konica Laser Imager DRYPRO model 771 is a laser imager converts data from diagnostic equipment such as CT, MRI, DSA, and other medical devices into various intensities, scan and then print the data onto laser imaging film.

Device Story

Drypro Model 771 is a laser imager; functions as medical image hardcopy device. Inputs: digital diagnostic data from imaging modalities (CT, MRI, DSA). Processing: converts digital data into varying intensities; scans and prints data onto laser imaging film. Output: hardcopy medical images. Used in clinical settings; operated by healthcare professionals. Facilitates diagnostic review by providing physical film copies of digital diagnostic images.

Clinical Evidence

Bench testing only.

Technological Characteristics

Laser imager; converts digital diagnostic data to hardcopy film. Class II device (21 CFR 892.2040).

Indications for Use

Indicated for use as a medical image hardcopy device to convert diagnostic data from CT, MRI, DSA, and other medical imaging equipment into printed laser imaging film.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted as a stylized bird-like figure with three lines representing the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2003

Konica Medical and Graphic Corp. % Mr. Shinichi Yamanaka Cosmos Corporation Business Section 319 Akeno, Obata-cho Watarai-gun, Mie-ken JAPAN

Re: K032681 Trade/Device Name: Drypro Model 771 Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: 90 LMC Dated: August 7, 2003 Received: September 2, 2003

Dear Mr. Yamanaka:

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.

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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

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

Enclosure

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510(k) Number (If known): Not known 4032481

Device Name: Konica Laser Imager DRYPRO model 771

Indications for Use:

The Konica Laser Imager DRYPRO model 771 is a laser imager converts data from diagnostic equipment such as CT, MRI, DSA, and other medical devices into various intensities, scan and then print the data onto laser imaging film.

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use \$\surd\$

OR Over The Counter Use

(Optional Format 1-2-96)

David A. Segerson

(Division Sign-Off) Division of Reproductive and Radiological Dev 510(k) Number