ELK LASER FILM DIGITIZER

K984409 · Nishimoto Sangyo Co., Ltd. · LMA · Feb 12, 1999 · Radiology

Device Facts

• Record ID: K984409
• Device Name: ELK LASER FILM DIGITIZER
• Applicant: Nishimoto Sangyo Co., Ltd.
• Product Code: LMA · Radiology
• Decision Date: Feb 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

The Model ED-3000 is a desk top laser image digitizer intended to produce digital copies of radiological film.

Device Story

The Elk Laser Film Digitizer (Model ED-3000) is a desktop device that converts analog radiological film into digital images. It utilizes a laser beam scanned in one direction and a mechanical stage that moves the film in an orthogonal direction. A light collector and photomultiplier capture the transmitted light, which is then processed by electronic circuitry for analog-to-digital conversion. The device connects to external networks via SCSI-2 or TWAIN interfaces. It is intended for use in clinical environments to facilitate the digitization of medical films for PACS integration. Healthcare providers use the resulting digital output for diagnostic review and storage. The device benefits patients by enabling digital archiving and electronic transmission of radiological studies.

Clinical Evidence

Bench testing only. The device was tested in accordance with the Standard for Medical Electric Equipment (JIS T 1001, T1002 200 edition). No clinical data was required or provided.

Technological Characteristics

Desktop laser film digitizer; laser diode (670µm) light source; mechanical stage for film transport; photomultiplier light collector; SCSI-2/TWAIN connectivity; 8/10/12-bit grayscale depth; optical density range 0-3.6 OD; scan rate 155 lines/sec. Complies with JIS T 1001/T1002 standards.

Indications for Use

Indicated for the production of digital copies of radiological film for clinical use.

Regulatory Classification

Identification

A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device 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

• Vidar, VXR-LS, Laser Film Digitizer (K974315)

Submission Summary (Full Text)

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2/12/99

# 510(k) Summary

# 1. Company Identification

K984409

Nishimoto Sangyo Co., Ltd. 2-17-4 Yushima Bunkyo, Tokyo, Japan Tel. [phone] Fax [phone] e-mail [e-mail]

## 2. Official Correspondent

Gary I. Allsebrook Regulatory Affairs

# 3. Date of Submission

December 7, 1998

#### 4. Device Name

| Classification Name: | Medical image digitizers were evaluated by the<br>Radiology panel and are classified in Class II per<br>21 CFR §892.2040 (proposed). | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|--|
| Common/Usual Name: | Laser Film Digitizer | |
| Proprietary Name: | Elk Laser Film Digitizer, Model ED-3000 | |

### 5. Substantial Equivalence

Vidar, VXR-LS, Laser Film Digitizer, K974315

## 6. Device Description and Intended Use

The ED-3000 is a desk top radiographic film digitizer incorporating a laser beam scanned in one direction, a mechanical stage that moves a sheet of film in the orthagonal direction, a light collector and photomutiplier and electronic circuitry for analog-to-digital conversion, system operation and connection to external networks. The intended use of the ED-3000 is to produce digital copies of radiological film.

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#### 7. Software

Nishimoto Sangyo Co., Ltd. certifies that the ED-3000 software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance.

## 8. Hazard Analysis

.

Hazard analysis on this product has been performed throughout the definition, design, coding and testing phases of product development and implementation. This process has emphasized:

- Identification of potential hazards, their causes, and their effects; ●
- Development of methodologies to control the occurrence of hazards and to ● constrain their effects; and
- Determine any effect on patient safety and system effectiveness.

The potential hazards associated with this software product are no different than those of other PACS components . These are primarily related to failure of computer system components, and may be variously obviated by decisions taken by the customers of this product. None of these failures are expected to materially contribute to patient death or injury.

It is our conclusion that there is no hardware or software component, operating in a properly configured environment, whose failure or latent design defect would be expected to result in death or injury of a patient. Thus the "Level of Concern" is "Minor".

#### 9. Safety Concerns

The device was submitted and passed the following tests in accordance with the Standard for Medical Electric Equipment (JIS T 1001, T1002 200 edition).

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# 10. Substantial Equivalence

The following product provides functions, which are substantially equivalent to this product. Please note that Nishimoto Sangyo is the Original Equipment Manufacturer (OEM) for the Vidar VXR-LS predicate device:

| Manufacturer: | Nishimoto Sangyo | Vidar |
|-----------------------|----------------------------------------|--------------------------------------------------|
| Product Name: | Elk Model ED-3000 | VXR-LS |
| 510(k) Number: | | K974315 |
| Film size: | 8"x10" - 14"x17" | 8"x10" - 14"x17" |
| Light Source | Laser Diode (670µm) | Laser Diode |
| Resolution: (14"x17") | | |
| DPI: | 73/146/293 | 73/146/293 |
| Pixel size (µm): | 320/160/80 | 348/174/87 |
| Pixels: | 1024 x 1244/2048 x<br>2488/4096 x 4976 | 1022 x 1241/2044 x<br>2482/4102 x 4981 |
| Density: | 8 bit/10 bit/12 bit | 8 bit (256) grayscale<br>12 bit (4096) grayscale |
| Optical Density: | 0~2/0~2.5/0~3/0~3.6 | 0.0 ~ 3.6 OD |
| Scan Rate: | 155 lines/sec. | 155 Lines/sec. |
| Interface: | SCSI-2/TWAIN (Win 95) | SCSI-2 conformance |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 1999

Nishimoto Sangyo Co., LTD Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA 94578-1116

Re:

:

K984409 Elk Laser Film Digitizer, Model ED-3000 Dated: December 7, 1998 Received: December 9, 1998 Regulatory class: II 21 CFR 892.2030/Procode: 90 LMA

Dear Mr. Allsebrook:

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 Act (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 vour 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,

S.S.T.

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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510(k) Number (if known):

Nishimoto Sangyo Co., Ltd. Elk Laser Film Digitizer, Model Device Name: ED-3000

Indications For Use:

The Model ED-3000 is a desk top laser image digitizer intended to produce digital copies of radiological film.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 901.109)

OR

Over-the-Counter Use_

Yhird A. Glymm

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K984409