KONICA DIRECT DIGITIZER REGIUS MODEL 350

K013054 · Konica Minolta Medical & Graphic, Inc. · MQB · Mar 1, 2002 · Radiology

Device Facts

• Record ID: K013054
• Device Name: KONICA DIRECT DIGITIZER REGIUS MODEL 350
• Applicant: Konica Minolta Medical & Graphic, Inc.
• Product Code: MQB · Radiology
• Decision Date: Mar 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Konica Direct Digitizer, REGIUS MODEL 350 is an X-ray image controller which uses a stimulative phosphor as X-ray detector and controls and manages digital X-ray image file processing.

Device Story

The Konica Direct Digitizer REGIUS MODEL 350 is an X-ray image controller utilizing a stimulable phosphor plate as an X-ray detector. The system includes a reading unit with an elevator platform for patient positioning and a control unit with a touch-panel CRT display and keyboard. Operation involves: 1) X-ray exposure of the phosphor plate; 2) laser scanning of the plate to emit light proportional to stored X-ray energy; 3) conversion of light to electrical signals via a photomultiplier tube (PMT) and then to digital signals via an A/D converter; 4) erasure of the plate using a halogen lamp for reuse. The device processes digital image files using automatic tonal processing and transfers them to external systems (printers, host computers, or storage). It is operated by clinical staff in hospital X-ray departments to manage digital X-ray workflows, facilitating image review and archival.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System consists of a reading unit and control unit. Detector: Stimulable phosphor plate. Laser: 690nm diode, 60mW. Conversion: PMT and A/D converter. Erasure: Halogen lamp. Connectivity: Transfer to printer, filing system, or display device. Power: AC100/200V. Operational environment: 15-30°C, 40-80% RH.

Indications for Use

Indicated for use in hospital X-ray departments to convert X-ray image data to digital signals and transfer data to printers, filing systems, or display devices. No specific patient population, age, or gender restrictions are stated.

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

• Konica Direct Digitizer, Model 330 (K980873)

Submission Summary (Full Text)

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510(k) Summary as required by EC7 32

K013054

### 1. Company Identification

MAR 4 2002

Konica Corporation

591-7,Kamihirose,Sayama-shi,Saitama-ken 350- 1.321 Japan

Tel : [phone]

Fax : [phone]

# 2. Official Correspondent

Koji Kubo (Mr.) Safety Standard Team Standards & Regulations Section Planning Department Imaging Systems Division

## 3. Date of Submission

August 20, 2001

## 4. Device Trade name

Konica Direct Digitizer REGIUS MODEL 350

### 5. Common Name

Film Digitizer CR /

- 6. Classification
Medical image digitizer was reviewed by the Rudiology Panel and are classified in Class II per 21 CFR 892. 2030.

## 7. Predicate Device

Konica Direct Digitizer, Model 330, 510(k) number: K980873

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### 8. Description of Device

The Konica Direct Digitizer, REGIUS MODEL 350 is an X-ray image controller which uses a stimulative phosphor as X-ray detector and controls and manages digital X-ray image file processing.

The system consists of an operator console, an image buffer section (hard disk) and control section. The operator consists of an operation CRT display that has a touch panel function, and a keyboard for entering text. An image file received from an industry-standard X-ray film cassette is processed using automatic tonal processing and is then transferred to an externally connected device including a host computer or CR printer.

For more information, please refer to the attachment.

### 9. Intended Use

The Konica Direct Digitizer, REGIUS MODEL 356 is an I-ray image controller which uses a Stimulative phosphor as X-ray detector and invended to control and manage digital X-ray image file processing.

#### 10. Substantial Equivalence to Predicate Device

The Konica Direct Digitizer, REGIUS MODEL 350 is substantially equivalent to our Konica Direct Digitizer REGIUS MODEL330,510(k) number: K980873. Comparison of the principal characteristics of the wo devices which are pertinent to Specification performance is shown below.

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| Item | Approved Medical Device | Medical Device Applied for Approval | Remarks |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Applicant, etc. | Company : Konica Corporation<br>Product Name : Konica Direct Digitizer<br>REGIUS MODEL 330<br>Approval No.: K980873 | Company : Konica Corporation<br>Product Name : Konica Direct Digitizer<br>REGIUS MODEL 350 | |
| Configuration | The device consists of a reading unit(the | The device consists of a reading unit(the | Same as the |
| | unit is combined with an elevator platform | unit is combined with an elevator platform | registered |
| | which horizontally positions the reading | which horizontally positions the reading | model |
| | device to suit to the height of the patient | device to suit to the height of the patient | |
| | through up-and-down movement) and a | through up-and-down movement) and a | |
| | control unit which performs the image<br>display, image transfer, etc. | control unit which performs the image<br>display, image transfer, etc. | |
| Principle of | X-ray image data of a patient is | X-ray image data of a patient is | Same as the |
| Operation | temporarily stored in the stimulable | temporarily stored in the stimulable | registered |
| | phosphor plate that is contained in the | phosphor plate that is contained in the | model |
| | device. | device. | |
| | <Exposure> | <Exposure> | |
| | After that the surface of the plate is | After that the surface of the plate is | |
| | scanned in time sequence by laser beam so | scanned in time sequence by laser beam so | |
| | that the amount of light according to the | that the amount of light according to the | |
| | amount of X-ray stored in the plate is | amount of X-ray stored in the plate is | |
| | emitted. The emitted light will be collected | emitted. The emitted light will be collected | |
| | and converted to electric signal by a | and converted to electric signal by a | |
| | photomultiplier tube (PMT), then to | photomultiplier tube (PMT), then to | |
| | digital signal by an A/D converter, etc.. | digital signal by an A/D converter, etc.. | |
| | <Reading> | <Reading> | |
| | After reading is completed, light of | After reading is completed, light of | |
| | halogen lamp is applied to the surface of | halogen lamp is applied to the surface of | |
| | the plate in order to erase the after-image. | the plate in order to erase the after-image. | |
| | <Erase> | <Erase> | |
| | Through this chain of operations | Through this chain of operations | |
| | (Exposure → Reading→Erase), repeat-use | (Exposure → Reading→Erase), repeat-use | |
| | of the plate is made possible. | of the plate is made possible. | |
| | The image data after being converted to | The image data after being converted to | |
| | digital signal is then transferred to the | digital signal is then transferred to the | |
| | controller and displayed on CRT. | controller and displayed on CRT. | |
| | After checking the image, the image data | After checking the image, the image data | |
| | will be transferred to the printer, | will be transferred to the printer, | |
| | magneto-optic disk drive, or host | magneto-optic disk drive, or host | |
| | computer | computer | |
| Specifications | • Type : Exclusively for the exposure of<br>stand position. | • Type : Exclusively for the exposure of<br>stand position | Upgrated. |
| | • Cycle Time : Max. 25 sec. or less.<br>(14x17in at 175 μm reading pitch) | • Cycle Time : Max. 17 sec. or less.<br>(17x17in at 175 μm reading pitch) | |
| | • Exposure Size : 5 sizes<br>(14x17in, 14x14in, 11x14in, 10x12in,<br>8x10in) | • Exposure Size : 6 sizes<br>(17x17in, 14x17in, 14x14in, 11x14in<br>10x12in, 8x10in ) | |
| | • Maximum Pixels(Read) :<br>Max. 4096 x 4924 pixel | • Maximum Pixels(Read) :<br>Max. 4860 x 4860 pixel | |
| | • Sampling Pitch : 9 types<br>(87.5, 100, 125, 137.5, 150, 175, 200,<br>212.5, 350 μm) | • Sampling Pitch : 2 types<br>(87.5, 175 μm) | |
| | • Gray Levels : 4096<br>• Laser Source: Laser Diode 780nm<br>• Laser Power: 200mW<br>• Laser Modulator; none<br>• Elevation stroke : 575mm or more<br>• Power Source : AC200V, 50/60Hz<br>• Power Consumption; 1.8kW<br>• Operational Environment :<br>Temperature : 20~30℃<br>Humidity : 35~80%RH<br>(Applicable to reading unit only) | • Gray Levels : 4096<br>• Laser Source: Laser Diode 690nm<br>• Laser Power. 60mW<br>• Laser Modulator; none<br>• Elevation stroke : 750mm or more<br>• Power Source : AC100/200V, 50/60Hz<br>• Power Consumption: 1.3kW<br>• Operational Environment :<br>Temperature : 15~30℃<br>Humidity : 40~80%RH | |
| Purpose of Use | The device is intended for the use at the<br>X-ray department of the hospital, etc. in<br>order to convert X-ray image data to<br>digital signal and to transfer the converted<br>data to printer, magneto-optic disk driver,<br>image display device, etc. | The device is intended for the use at the<br>X-ray department of the hospital, etc. in<br>order to convert X-ray image data to<br>digital signal and to transfer the converted<br>data to printer filing system, image<br>display device etc. | Same as the<br>approved device. |

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

#### 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

Konica Corporation % Mr. Shinichi Yamanaka Cosmos Corporation 319 Akeno, Obata-cho Watarai-gun, Mie-ken 519-05 JAPAN

AUG 23 2013

Re: K013054

Trade/Device Name: Konica Direct Digitizer Regius Model 350 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: November 26, 2001 Received: December 3, 2001

Dear Mr. Yamanaka:

This letter corrects our substantially equivalent letter of March 2, 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 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 K 013554

Device Name: KONICA PIRCOT PICITIZER, REGIUS MODEL 350

Indications for Use:

: .

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The Konica Direct Digitizer, REGIUS MODEL 350 is an X-ray image controller which uses a stimulative phosphor as X-ray detector and controls and manages digital X-ray image file processing.

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

Concurrence of CDRH, Office of Device Evaluation

v Prescription Use

#### OR Over-The-Counter Use

(Optional Format 1-2-96)

David A. Syrom

(Division Sign-Om
Division of Reproductive, Abdominal,
and Radiological Devices K013064
510(k) Number_