MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190
Device Facts
| Record ID | K052095 |
|---|---|
| Device Name | MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 |
| Applicant | Konica Minolta Medical & Graphic, Inc. |
| Product Code | MQB · Radiology |
| Decision Date | Nov 3, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
Indications for Use
The Direct Digitizer, REGIUS MODEL 190 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 190 is used to obtain image data of long areas of anatomy such as the whole spine or the whole lower leg. REGIUS MODEL 190 is also used to obtain image data to verify the position for a radiotherapy location. It is designed intended to use in a clinic, a radiology department in a hospital and in other medical facilities. It is not intended to be used with digital mammography system.
Device Story
REGIUS MODEL 190 is an X-ray image reader; utilizes stimulable phosphor plates (PSP) in cassettes as X-ray detectors. Device reads latent images via laser scan and photoelectric conversion; performs digital signal processing including filtering, gain-offset correction, and shading collection. Output transferred to external host computers, displays, or printers. Modifications enable long-length imaging (stitching multiple PSP plates) and radiotherapy localization (handling heavy cassettes containing metal plates). Used in clinics and hospital radiology departments by trained personnel. Benefits include high-resolution digital capture of large anatomical areas and precise radiotherapy positioning verification.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
X-ray image reader using photostimulable phosphor plates. Connectivity via external interface to host computers/printers. Complies with UL60601-1, IEC60601-1, IEC60601-1-2, and 21 CFR 1040.10. Features laser scanning and photoelectric detection. Software performs digital filtering, gain-offset correction, and shading collection.
Indications for Use
Indicated for patients requiring X-ray imaging of long anatomical areas (e.g., whole spine, whole lower leg) or radiotherapy position verification. 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, MODEL 190 (K042386)
Submission Summary (Full Text)
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as required by 807.92
#### 1. Company Identification NOV - 8 2005
KONICA MINOLTA MEDICAL & GRAPHIC, INC. 2970 Ishikawa-machi Hachioji-shi, Tokyo 192-8505, Japan Tel: +81-426-60-9607 Fax: +81-426-60-9588
## 2. Official Correspondent
Masafumi Saito(Mr.) Department TS Advanced Technology Division R & D Center
# 3. Date of Submission
July 11th, 2005
### 4. Device Trade Name
Direct Digitizer REGIUS MODEL 190
## 5. Common Name
Direct Digitizer
### 6. Classification
Medical image digitizers were reviewed by the Radiology Panel and are classified in Class II per 21 CFR 892. 1650.
## 7. Predicate Device
Modified Direct Digitizer REGIUS MODEL 190 is substantially equivalent to our current Direct Digitizer, MODEL 190, 510(k) number: K042386.
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#### 8. Description of Device
The Direct Digitizer, REGIUS MODEL 190 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 the REGIUS MODEL 190. By means of laser scan and photoelectric method, the 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. The signal processing is made to the digital image data such as the digital filtering, the gain-offset correction and the shading collection. Then the REGIUS MODEL 190 is capable of transferring 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.
The modifications are 1) Applicable cassette size is increased. 2) Read-Only cassettes are added, 3) Exposure-Only cassettes are added, and 4) Function of a reader console is upgraded.
The purpose of modification is to enable to use of multiple cassettes 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 obtain images to verify the position for a radiotherapy location.
#### · Long Length Imaging feature
This is suitable for ordinary exposure of the skeletal system such as the whole spine or the whole lower leg, and is used for measurement purposes, such as measurement of skeletal deformation. 14x42in, 14x51in, 11x28in, 10x36in sizes are required for the exposure size, and the exposure is made onto a photostimulable phosphor plate formed by joining a number of photostimulable phosphor plates of reqular size.
- Read-Only Cassettes and Exposure-Only Cassettes used for Long Length . Imaging feature
Exposure-Only Cassette can not be set to REGIUS MODEL 190, because size does not match.
Read-Only Cassette can be set to REGIUS MODEL 190.
In order to set to REGIUS MODEL 190, the plates are removed from the Exposure-Only Cassette and loaded to Read-Only Cassettes.
When the image is read onto REGIUS MODEL 190, the cassette is fed into the device, the photostimulable phosphor plate contained in the cassette uncovered and the image information recorded on the plate scanned and read out.
REGIUS MODEL 190, using Exposure-Only cassettes that incorporate multiple
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plates (joined) for exposure and Read-Only cassettes that incorporate a single plate so that the cassette size is small enough to be accepted by the device, enable image reading similar to ordinary X-ray exposure by replacement of the photostimulable phosphor plates.
#### Radiotherapy localization for Linac Graphy .
Linac Graphy is used as part of linac (Linear Accelerator) treatment, a kind of radiotherapy (in cases of external radiation radiotherapy).
First of all, design a treatment plan including the irradiation field size and irradiation amount so that the dose to which the patient is exposed during radiotherapy is minimized.
To make a test exposure in order to design the treatment plan, expose the body part positioned as it would be during actual treatment using a CT, etc., and develop the treatment plan based on the information thus obtained.
Then, mark the treatment-target area of the body part that is actually positioned on the treatment table for linac, and, after checking the treatment position using the photo for position verification by linac graphy technology, initiate the treatment.
One method of photographic procedure to produce images used to verify the position is the method using REGIUS MODEL 190, Photostimulable Phosphor Plate and exposure cassette containing metal plate to prevent over exposure problem where all of the exposed images are recorded on the photostimulable phosphor plate exactly as for general X-ray exposures.
- Read-Only Cassettes and Exposure-Only Cassettes used for Radiotherapy • localization
When the image is read on REGIUS MODEL 190, the cassette is fed into the device, the photostimulable phosphor plate contained in the cassette uncovered and the image information recorded on the plate scanned and read out.
Because the above mentioned cassette for linac graphy contains a metal plate, it is difficult to feed such a cassette into the device due to its weight that is relatively greater than that of a normal X-ray cassette. Therefore, REGIUS MODEL 190, using Exposure-Only cassettes incorporating a metal plate and Read-Only cassettes with photostimulable phosphor plates processed in the device after exposure, enable image reading identical to ordinary X-ray exposure by replacement of the photostimulable phosphor plate after exposure.
Risk analysis is the same as our current REGIUS MODEL 190, K042386. (We consider no new risk will arise and therefore we did not conduct a new risk analysis.)
Software information is also the same as current REGIUS MODEL 190, K042386.
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Labeling (User operation manual) is added to current REGIUS MODEL 190. Additional part of Labeling from the current REGIUS MODEL 190 is attached. For more information, please refer to the attachments.
#### 9. Intended Use
The Direct Digitizer, REGIUS MODEL 190 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 190 is used to obtain image data of long areas of anatomy such as the whole spine or the whole lower leg.
REGIUS MODEL 190 is also used to obtain image data to verify the position for a radiotherapy location.
It is designed intended to use in a clinic, a radiology department in a hospital and in other medical facilities.
It is not intended to be used with digital mammography system.
## 10. Substantial Equivalence to Predicate Device
The Direct Digitizer, REGIUS MODEL 190 is substantially equivalent to our current Direct Digitizer REGIUS MODEL190, 510(k) number: K042386. Comparison of the principal characteristics of the two devices is shown in the attachments.
#### 11. Compliance standards
The Direct Digitizer, REGIUS MODEL 190 complies with the following standards:
| Safety standard | :UL60601-1, IEC60601-1 |
|-------------------------------|------------------------|
| Electromagnetic Compatibility | : FCC, IEC60601-1-2 |
| Radiation safety | : 21 CFR 1040,10 |
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Image /page/4/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of two parts: a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized blue image of a human figure, and the text is in blue, with each word on a separate line.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Masafumi Saito Manager, Department TS Konica Minolta Medical & Graphic, Inc. 2970 Ishkawa-cho HACHIOJI-SHI TOKYO 192-8505 JAPAN
AUG 2 3 2013
Re: K052095
Trade/Device Name: Direct Digitizer REGIUS Model 190 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: September 20, 2005 Received: September 30, 2005
Dear Mr. Saito:
This letter corrects our substantially equivalent letter of November 5, 2005.
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 requirences as sot forth in the quality of evice as described in your Section 510(k) premarket witi anow you to begin finding of substantial equivalence of your device to a legally marketed notheation. The I Drice 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 11 you desire specific advice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 under the MDA regulation (2) "OFFY ar roo), portaProblem/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 Tour may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 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) : K052095
.. Direct Digitizer, REGIUS Model 190 Device Name
Indications For Use:
The Direct Digitizer, REGIUS MODEL 190 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 190 is used to obtain image data of long areas of anatomy such as the whole spine or the whole lower leg.
REGIUS MODEL 190 is also used to obtain image data to verify the position for a radiotherapy location.
It is designed intended to use in a clinic, a radiology department in a hospital and in other medical facilities.
It 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)
| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K052095 |
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