KONICA DIRECT DIGITIZER REGIUS, MODEL 170

K023061 · Konica Minolta Medical & Graphic, Inc. · MQB · Oct 11, 2002 · Radiology

Device Facts

• Record ID: K023061
• Device Name: KONICA DIRECT DIGITIZER REGIUS, MODEL 170
• Applicant: Konica Minolta Medical & Graphic, Inc.
• Product Code: MQB · Radiology
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Konica Direct Digitizer Model 170 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.

Device Story

Direct Digitizer Model 170 functions as a digital radiography system; replaces traditional film/screen systems. Device captures X-ray exposure data; transforms signals into digital radiographic images of human anatomy. Used in clinical settings for general-purpose diagnostic procedures; operated by trained healthcare professionals (radiologic technologists/physicians). Output displayed on workstation monitors for clinical review; facilitates diagnostic decision-making by providing digital image data for interpretation. Benefits include improved image management, storage, and potential for digital image enhancement compared to analog film.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

Stationary X-ray system (21 CFR 892.1680). Digital radiography digitizer; replaces film/screen systems. Class II device. Technical specifications and materials not detailed in provided text.

Indications for Use

Indicated for use in generating radiographic images of human anatomy for general-purpose diagnostic procedures, intended to replace radiographic film/screen systems.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Shinichi Yemanaka Safety Department Cosmos Corporation 319 Akeno, Obata-cho, Watarai-gun, Mei-ken, 519-05 JAPAN

AUG 2 3 2013

Re: K023061

Trade/Device Name: Direct Digitizer REGIUS Model 150 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 3, 2002 Received: September 16, 2002

Dear Mr. Yemanaka:

This letter corrects our substantially equivalent letter of October 11, 2002.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (If known): Not known × ○ 2 30 6 /

Device Name: Konica Direct Digitizer Model 170

Indications for Use:

The Konica Direct Digitizer Model 170 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.

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

Concurrence of CDRH, Office of Device Evaluation

**Prescription Use**

OR Over-The-Counter Use

(Optional Format 1-2-96)

David G. Ingram

510kl N