DIRECT DIGITIZER, REGIUS MODEL 110

K071181 · Konica Minolta Medical & Graphic, Inc. · MQB · May 30, 2007 · Radiology

Device Facts

• Record ID: K071181
• Device Name: DIRECT DIGITIZER, REGIUS MODEL 110
• Applicant: Konica Minolta Medical & Graphic, Inc.
• Product Code: MQB · Radiology
• Decision Date: May 30, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Direct Digitizer, REGIUS Model 110 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 110 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 digital mammography system.

Device Story

Direct Digitizer REGIUS Model 110 is a computed radiography (CR) image reader. Input: latent X-ray images recorded on stimulable phosphor plates within cassettes. Operation: laser scanning and photoelectric conversion of latent images into digital data. Output: digital image data transferred to external systems (host computers, displays, printers, filing devices). Usage: clinical/hospital radiology departments by trained personnel. Compact design modification of predicate; utilizes same technology as REGIUS Model 190 and 150. Supports long-anatomy imaging and radiotherapy positioning verification. Benefits: enables digital conversion of radiographic images for diagnostic and therapeutic planning.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Computed radiography reader using stimulable phosphor plates. Laser scanning and photoelectric detection. Compact form factor. Connectivity: digital data transfer to external workstations/printers. Compliance: IEC60601-1, IEC60601-1-2, 21 CFR 1040.10, IEC60825-1.

Indications for Use

Indicated for trained medical personnel in clinics, hospitals, and medical facilities to read X-ray images from stimulable phosphor plates for general radiographic imaging and radiotherapy positioning. Not for use with digital mammography 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

• Model DD341 / REGIUS150 (K0990359)
• REGIUS CONSOLE CS-2000/3000 (K051523)

Submission Summary (Full Text)

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# 510(k) Summary

K071181

#### As required by 807.92

MAY 3 0 2007

## 1. Company Identification

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

### 2. Official Correspondent Koji Matsushima (Mr.) Manager

Standards & Regulations Department, Quality Assurance Center

# 3. Date of Submission

April 26, 2007

## 4. Establishment Registration No. 3003769120

## 5. Device Trade Name Direct Digitizer, REGIUS Model 110

#### 6. Common Name

Computed Radiography Image Reader

#### 7. Classification

Class 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 110 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 110 also reads the image

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data of long areas of anatomy and to verify the position for a radiotherapy location.

The Regius 110 is really just a minor modification of our 510k cleared Direct Digitizer, REGIUS Model 190, 510(k) number: K052095. The features in the Regius 110 that are different than the Regius 190 are minor and are features that are present in the 510k cleared Model DD341 / REGIUS150, 510(k) number: K0990359 which we have included on the Comparison Table.

The modification was made to the Regius 110 to achieve a more compact design. To achieve the compact design, the Maximum Image Matrix Size and Sampling Pitch are decreased from the Size and Pitch in the REGIUS Model 190 and the transport is slightly different. However, these differences are the same technology as found in the 510k cleared Model DD341 / REGIUS150.

Please refer to section 2, Substantial Equivalence Comparison Table for details. The basic operations of REGIUS Model 110 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) and so on. 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.

This device is not intended for use with digital mammography system.

#### 10. Intended Use

The Direct Digitizer, REGIUS Model 110 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 110 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 digital mammography system.

## 11. Substantial Equivalence to Predicate Device

The Direct Digitizer, REGIUS Model 110 is substantially equivalent to our Direct Digitizer REGIUS Model 190, 510(k) number: K052095. Comparison of the principal characteristics is shown in the Section 2.

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## 12. Compliance Standard

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

## 13. Conclusion

The Direct Digitizer, REGIUS Model 110 has the same intended use and basically the same technological characteristic as the predicate device which is approved 510(k) number: K052095. This Special 510(k) has demonstrated substantial equivalence as the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol appears to be a stylized representation of a human figure or a caduceus. The text is in a clear, sans-serif font and is likely intended to convey the official nature of the organization.

Public Health Service

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

Konica Minolta Medical & Graphic, Inc. % Mr. Russell Munves Official Correspondent Storch, Amini & Munves, P.C. 140 East 45th Street, 25th Floor Two Grand Central Tower NEW YORK NY 10017

AUG 23 2013

Re: K071181

Trade/Device Name: Direct Digitizer. REGIUS Model 110 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: April 26, 2007 Received: April 30, 2007

Dear Mr. Munves:

This letter corrects our substantially equivalent letter of May 30. 2007.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a viewed your ve 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 coninered phorts to May 20, 1976, tip 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 I ou may, merciore, manel 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 If your device is Classified (see abor 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 that I DA has made a could regulations administered by other Federal agencies. You must or any I catal statutes and regulanents, 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 whitiation. 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 If you desire specific at 100 for your won Diagnostic Device Evaluation and Safety at (301) 796-007), program note the regulation entitled, "Misbranding by reference to premarket 5-156. Thise from 110.0 more 2019.97). 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)

2671181

Device Name

Direct Digitizer, REGIUS Model 110

Indications for Use:

The Direct Digitizer, REGIUS Model 110 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 fillng device, and other image reproduction devices. REGIUS Model 110 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 digital mammography system

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)

Huld Hensling

roductive, Abdominal, and

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