DRY LASER IMAGER, MODEL DRYPRO MODEL 793

K042133 · Konica Minolta Medical & Graphic, Inc. · LMC · Nov 24, 2004 · Radiology

Device Facts

• Record ID: K042133
• Device Name: DRY LASER IMAGER, MODEL DRYPRO MODEL 793
• Applicant: Konica Minolta Medical & Graphic, Inc.
• Product Code: LMC · Radiology
• Decision Date: Nov 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2040
• Device Class: Class 2

Intended Use

The Dry Laser Imager, DRYPRO Model 793 is intended to be used to acquire of images from diagnostic equipment such as CT, MRI, DSA or Full Field Digital Mammography System and print the images on medical dry film. The devices are intended to be used by trained medical personnel in a clinic or hospital environment.

Device Story

The DRYPRO Model 793 is a medical image hardcopy device; it receives digital image data from diagnostic equipment (CT, MRI, DSA, or Full Field Digital Mammography systems). The device utilizes a semiconductor laser scanning system to expose medical dry film, which is then processed through a heat developing unit. It is operated by trained medical personnel in hospitals or clinics. The output is a physical hardcopy of diagnostic images, which healthcare providers use for clinical review and diagnostic decision-making. The device integrates into existing radiology workflows to provide permanent film records of digital diagnostic studies.

Clinical Evidence

Bench testing only.

Technological Characteristics

Medical image hardcopy device; semiconductor laser scanning technology; heat developing unit; film supplying/transferring units; DICOM connectivity; complies with 21 CFR 1040.10, UL60601-1, IEC60601-1, IEC60601-1-2, and IEC60825.

Indications for Use

Indicated for use by trained medical personnel in clinical or hospital settings to acquire and print diagnostic images from CT, MRI, DSA, or FDA-approved Full Field Digital Mammography systems onto medical dry 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.

Predicate Devices

• DRYVIEW 8900 (K033821)

Submission Summary (Full Text)

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NOV 2 4 2004

510(k) Summary as required by 807.92

12042193

# 1. Company Identification

Konica Minolta Medical & Graphic Inc. 2970 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8505 Japan :011-81-426-60-9607 Tel Fax : [phone]

# 2. Official Correspondent

Koji Kubo (Mr.) Assistant Manager Technical Support Group

#### 3. Date of Submission

August 6, 2004

# 4. Establishment Registration No.

3003769120

#### 5. Device Trade name

Dry Laser Imager, DRYPRO Model 793

# 6. Common Name

Medical Image Hardcopy Device

## 7. Classification

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

- 8. Product Code
90 LMC

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#### 9. Predicate Device

The Dry Laser Imager, DRYPRO Model 793 is substantially equivalent to DRYVIEW 8900 manufactured by Eastman Kodak Company, 510(k) No.i K033821.

Comparison of the principal characteristics of the two devices which are pertinent to Specification performance is attached below.

#### 10. Description of Device

The Dry Laser Imager, DRYPRO Model 793 is a Laser Imager to acquire images from diagnostic equipment such as CT, MRI, DSA or Full Field Digital Mammography System and print them on medical dry-film.

The device consists of film supplying unit and film transferring unit and exposing unit and heat developing unit and operating unit and power supplying unit and main control unit.

This product employs semiconductor laser scanning, but it complies with the Federal Performance Standard 21 CFR Part 1040.10.

#### 11. Intended Use

The Dry Laser Imager, DRYPRO Model 793 is intended to be used to acquire of images from diagnostic equipment such as CT, MRI, DSA or Full Field Digital Mammography System and print the images on medical dry film.

The devices are intended to be used by trained medical personnel in a clinic or hospital environment.

# 12. Compliance Standard

UL60601-1 (expected to be approved by the end of October, 2004), IEC60601-1. IFC60601・1・2, IEC60825, 21 CFR 1040.10, DICOM

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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 eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 2 4 2004

Konica Minolta Medical & Graphics, Inc. Re: K042133 % Mr. Shinichi Yamanaka Progress Section Cosmos Corporation 319 Akeno, Obata-cho Watarai-gun, Mie-ken 519-0501 JAPAN

Trade/Device Name: Dry Laser Imager, DRYPRO Model 793 Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: 90 LMC

Dated: October 28, 2004

Received: October 29, 2004

Dear Mr. Yamanaka:

ﺮ ﻣﻦ

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 (Premárket Approval), 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 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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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

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# Indications for Use

510(k) Number (if known) : Dry Laser Imager, DRYPRO Model 793 Device Name

Indications For Use:

The Dry Laser Imager, DRYPRO Model 793 is intended to be used to acquire images from diagnostic equipment such as CT, MRI, DSA or FDA-approved Full Field Digital Mammography System and print the images on medical dry-film.

The devices are intended to be used by trained medical personnel in a clinic or hospital environment.

Prescription Use (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 L. Brogdon
Division Sign-Off

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