FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER

K993861 · Fujifilm Medical System U.S.A., Inc. · MQB · Feb 10, 2000 · Radiology

Device Facts

• Record ID: K993861
• Device Name: FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER
• Applicant: Fujifilm Medical System U.S.A., Inc.
• Product Code: MQB · Radiology
• Decision Date: Feb 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The indications for use of the Fuji Computed Radiography Dual Side Reading is the same as the predicate device: the identification, capture, digitization, and processing of diagnostic x-ray images, and associating patient and exam identification with the images.

Device Story

Device is a computed radiography system (FCR 5501D) consisting of an image reader and photostimulable phosphor imaging plates (IPs). System is cassetteless with IPs integrated into an upright exam stand/reader. After x-ray exposure, the IP is scanned, erased, and held for reuse; allows continuous workflow without waiting for erasure. IP uses europium-activated barium fluorohalide compounds in a crystal form with an organic binder. Key innovation is a transparent support layer allowing emission detection from both sides of the IP, increasing detective quantum efficiency (DQE) by 30-40% compared to single-side reading. Used in clinical settings by radiology staff to produce digital diagnostic images. Output is processed digital x-ray data used by clinicians for diagnostic decision-making.

Clinical Evidence

Bench testing only. Comparison of modulation transfer function (MTF) and detective quantum efficiency (DQE) against predicate devices. Results show virtually identical MTF and a 30-40% increase in relative DQE for the dual-side reading method.

Technological Characteristics

Computed radiography system. Imaging plate (ST-55 BD) features europium-activated barium fluorohalide phosphor, 320 micrometer thickness, and transparent support layer. 10-bit grayscale (1024 levels). Conforms to UL Standard 2601-1 for medical electrical equipment safety.

Indications for Use

Indicated for the identification, capture, digitization, and processing of diagnostic x-ray images, and associating patient and exam identification with the images.

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

• FCR 9501 (K944046)
• FCR 9501HQ (K951373)

Submission Summary (Full Text)

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FEB 1 0 2000

Image /page/0/Picture/1 description: The image shows the Fujifilm logo. The logo consists of a stylized graphic element on the left, followed by the word "FUJIFILM" in bold, sans-serif font. The graphic element is a geometric shape with the letters "fuji" embedded within it. The text is all in black.

I - Imaging & Information

FUJI MEDICAL SYSTEMS U.S.A., INC.

419 WEST AVENUE STAMFORD, CT 06902 Telephone: [phone] Fax: [phone]

K993861

Page 1 of 3

510(k) Summary [as required by 21 CFR 807.92]

#### Date Prepared [21 CFR 807.92(a)(1)]

November 12, 1999

## Submitter's Information [21 CFR 807.92(a)(1)]

Fuji Medical Systems U.S.A., Inc. 419 West Avenue Stamford, Connecticut 06902 Telephone: [phone] Facsimile: [phone] Contact: Joseph M. Azary

# Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

The device trade names are:

- Fuji Computed Radiography Dual Side Reading .
- . Fuji Computed Radiography Both Side Reading
- . Fuji Computed Radiography FCR 5501D Dual Side Reader

The device common or classification names are: Computed radiography system, FCR system, digital imaging system.

#### Predicate Device [21 CFR 807.92(a)(3)]

Fuji identifies the predicate devices as follows:

| Subject Device | FCR 5501D Dual Side Reader<br>(Standard Pixel Density Image<br>Mode) | FCR 5501D Dual Side Reader<br>(High Pixel Density Image Mode) |
|-----------------------------|----------------------------------------------------------------------|---------------------------------------------------------------|
| Predicate Device | FCR 9501 | FCR 9501HQ |
| 510(k) for Predicate Device | K944046 | K951373 |
| Classification | Class II, 892.1900 | Class II, 892.1900 |
| Product Code | 90LLZ and 90IXW | 90LLZ and 90IXW |

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# Description of the Device [21 CFR 807.92(a)(4)]

K993861
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The Fuji Computed Radiography Dual Side Reading consists of an image reader (FCR 5501D Dual Side Reader) and Imaging Plates (described below). The image reader is cassetteless because the IPs are built-into this upright exam stand/reader. After exposure, the IP is in turn to the scanning, erasing, and holding areas. For the operator, this means that as soon as the IP is exposed , another is brought into the exposure area, without having to wait for reading and erasure.

As with other FCR image readers, the FCR 5501D Dual Side Reader will feature a photostimulable phosphor imaging plate composed of europium activated barium fluorohalide compounds in a crystal form held in an organic binder. The Imaging Plate used with the subject device (ST-55 BD) will have a transparent support, which will allow emission detection from both the support side and phosphor side of the IP.

| IP Characteristic | ST-55 BD (Dual Side IP) | ST-V, ST-VA, ST-VN |
|-----------------------|--------------------------------------------|-------------------------------|
| Thickness | 320 micrometers; thicker phosphor<br>layer | 230 micrometers |
| Protective Layer | Protective Layer is present | Protective Layer is present |
| Support Layer | Transparent Support | Non-transparent support |
| Light Shielding Layer | Not present | Light Shielding Layer present |

### Intended Use [21 CFR 807.92(a)(5)]

The indications for use of the Fuji Computed Radiography Dual Side Reading is the same as the predicate device: the identification, capture, digitization, and processing of diagnostic x-ray images, and associating patient and exam identification with the images.

### Technological Characteristics [21 CFR 807.92(a)(6)]

The subject device represents a change to the predicate devices (FCR 9501HQ) that allows for reading on both sides of the imaging plate. The technology used in the subject device is a scientific article entitled "Novel Computed Radiography System with Improved Image Quality by Detection of Emissions from Both Sides of an Imaging Plate" by Satoshi Arakawa, Wataru Itoh, Katsuhiro Kohda, Toshiaki Suzuki.

The gray scale is 10 bits (1024 gray levels) for both the predicate and subject devices. The sampling raster of the subject device is identical to that of the predicate device. The one exception is that the subject device offers additional IP reading area sizes, such as 17x17 in., 17x14 in., and 18x43cm.

# Performance Data [21 CFR 807.92(b)(1)]

Based on our scientific data we found the modulation transfer function (MTF) for the subject device is virtually identical to the MTF data for the predicate devices. Additionally, the relative detective quantum efficiency (DQE) for the subject device provides a 30-40% increase in relative DQE, as compared to the predicate device.

> 510 (k) Fuji Dual Side Reading

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K993861
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The subject device was tested by Underwriters Laboratories Inc. and found to conform to the UL Standard 2601-1 Medical Electrical Equipment Part 1: General Requirements for Safety (File E179671, Project 99SC47495).

#### Conclusion [21 CFR 807.92(b)(3)]

In conclusion, the Fuji Computed Radiography Dual Side Reading are nearly identical in design, materials, construction, and function to the predicate devices. The main difference is that the subject device (image reader and imaging plate) have been modified in a manner that allows emission from both sides of the imaging plate.

For a radiographic imaging system, image quality is the principal area of concern for safety and effectiveness. The results of laboratory tests demonstrate the subject devices provide equivalent MTF and increased DOE. In fact, based on test data the dual side reading method enhances image quality.

The subject device conforms to UL Standard 2601-1 Medical Electrical Equipment Part 1: General Requirements for Safety (File E179671, Project 99SC47495).

We conclude that the subject devices are as safe and effective as the predicate device.

510 (k) Fuji Dual Side Reading

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2000

Joseph M. Azary Regulatory Affairs Coordinator Fuji Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT 06902

Re:

K993861 Fuji Computed Radiography Image Reader with Dual Side IP Reading Dated: November 12, 1999 Received: November 15, 1999 Regulatory class: II 21 CFR 892.1630/Procode: 90 MQB

Dear Mr. Azary:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 Ad (Act). 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 either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register, Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5 10(k) Number (if known):

Device Name: Fuji FCR 5501D

Indications For Use:

The indications for use of the FCR 5501D is the same as the predicate device: the identification, capture, digitization, and processing of diagnostic x-ray images, and associating patient and exam identification with the images.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

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Division of Reproductive, Abdominal, ENTDivision of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

210 (k) Fuji Dual Side Reading

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