DIRECT DIGITIZER, REGIUS MODEL 210

K092717 · Konica Minolta Medical & Graphic, Inc. · MQB · Oct 30, 2009 · Radiology

Device Facts

• Record ID: K092717
• Device Name: DIRECT DIGITIZER, REGIUS MODEL 210
• Applicant: Konica Minolta Medical & Graphic, Inc.
• Product Code: MQB · Radiology
• Decision Date: Oct 30, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Direct Digitizer, REGIUS Model 210 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It reads the image recorded on the Plate and transfers the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices. REGIUS Model 210 also reads the image data of long areas of anatomy and the image data to verify the position for radiotherapy localization. It is designed and intended to be used by trained medical personnel in a clinic, a radiology department in a hospital and in other medical facilities. This device is not intended for use with FFDM systems.

Device Story

Direct Digitizer, REGIUS Model 210 is an X-ray image reader; utilizes stimulable phosphor plates in cassettes as detectors. Device reads latent X-ray images via laser scan and photoelectric conversion; transforms analog latent images into digital data. Supports long-length anatomy imaging via multiple cassette stitching; provides radiotherapy localization verification. Operated by trained medical personnel in clinics or hospitals. Output transferred to external host computers, displays, printers, or filing systems. Device increases processing capacity compared to predicate; hardware remains unchanged; software algorithm modified. Benefits include efficient digital image acquisition and integration into existing radiology workflows.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stimulable phosphor plate X-ray detector; laser scan and photoelectric reading method. Connectivity via external interface to host computers/printers. Compliance with IEC60601-1 (safety), IEC60601-1-2 (EMC), and IEC60825-1 (radiation safety).

Indications for Use

Indicated for trained medical personnel in clinical or hospital radiology settings to read X-ray images from stimulable phosphor plates. Supports long-length anatomy imaging and radiotherapy localization verification. Not for use with Full-Field Digital Mammography (FFDM) 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.

Predicate Devices

• Direct Digitizer, REGIUS Model 190 (K052095)

Reference Devices

• REGIUS CONSOLE CS-2000/3000 (K051523)

Submission Summary (Full Text)

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(0927.1)

## 510(k) Summary

#### As required by 807.92

## 1. Company Identification

OCT 3 0 2009

Konica Minolta Medical & Graphic, Inc. 2970 Ishikawa-machi, Hachioji-shi, Tokyo 192-8505, Japan Phone: [phone] Fax: [phone] ·

- 2. Official Correspondent Koji Matsushima (Mr.) General Manager Standards & Regulations Department
3. Date of Submission August 28, 2009

Quality Assurance Center

4. Establishment Registration No. 3003769120

5. Device Trade Name Direct Digitizer, REGIUS Model 210

- 6. Classification Name Solid State X-Ray Imager
#### 7. Classification

Ciass II , 90 MQB, 21 CFR 892.1630.

## 8. Predicate Device

Direct Digitizer, REGIUS Model 190, 510(k) number: K052095

## 9. Description of Device

The Direct Digitizer, REGIUS Model 210 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette, and reads the Image recorded on the Plate by inserting a cassette in the entrance slot of this device. By means of laser scan and photoelectric method, this device reads the X-ray image data created in form of a latent image on the Plate exposed by an external X-ray generating device, and converts the read data into digital. REGIUS Model 210 also enables to use of

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multiple cassette to obtain images of long areas of anatomy and then to present the images as a single composite image (Long Length Imaging feature), and to use Read-Only Cassettes and Exposure-Only Cassettes used for Radiotherapy localization.

Different points between REGIUS Model 210 and REGIUS Model 190, which is approved 510(k) number: K052095 is that REGIUS Model 210 has higher processing capacity than REGIUS Model 190. To increase the processing capacity, the software algorithm is modified. However, the hardware remains unchanged. The exterior appearance is slightly modified.

The basic operations of REGIUS Model 210 such as a starting, a shut down, a registration-of-patient, a setting of a various condition are operated with the optional Image Processing Work Station, REGIUS CONSOLE CS-2000/3000 (510(k) cleared, K051523, July 20, 2005). Then the image data transfer to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices.

#### 10. Intended Use

The Direct Digitizer, REGIUS Model 210 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It reads the image recorded on the Plate and transfers the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices. REGIUS Model 210 also reads the image data of long areas of anatomy and the image data to verify the position for radiotherapy localization. It is designed and intended to be used by trained medical personnel in a clinic, a radiology department in a hospital and in other medical facilities.

This device is not intended for use with FFDM systems.

#### 11. Substantial Equivalence to Predicate Device

The Direct Digitizer, REGIUS Model 210 is substantially equivalent to our Direct Digitizer REGIUS Model 190, 510(k) number: K052095.

Comparison of the principal characteristics of these devices is shown in the Section 8.

## 12. Compliance Standard

: IEC60601-1 Ed.2(1988)+ A1(1991)+A2(1995) Safety standard Electromagnetic Compatibility : IEC60601-1-2 Ed.2(2001)+A1(2004) : 21 CFR 1040.10, IEC60825-1(1993)+A1(1997)+A2:2001 Radiation safety

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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

AUG 2 3 2013 Konica Minolta Medical & Graphic, Inc. % Mr. Russel Munves Official Correspondent Storch, Amini & Munves, P.C. 140 East 45th St., 25th Floor Two Grand Central Tower NEW YORK NY 10017

Re: K092717

Trade/Device Name: Direct Digitizer, REGIUS Model 210 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 15. 2009 Received: October 16, 2009

Dear Mr. Munves:

This letter corrects our substantially equivalent letter of October 30, 2009.

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. Iisting 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 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 nredicate 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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# Indications for Use

510(k) Number (if known)

K:092717

Device Name

Direct Digitizer, REGIUS Model 210

Indications for Use:

The Direct Digitizer, REGIUS Model 210 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It reads the image recorded on the Plate and transfers the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices. REGIUS Model 210 also reads the image data of long areas of anatomy and to verify the position for a radiotherapy location. It is designed and intended to be used by trained medical personnel in a clinic, a radiology department in a hospital and in other medical facilities.

This device is not intended for use with FFDM systems

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)

ivision of Reproductive. Abdomina and Radiological Devic

510(k) Number

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