FILM DIGITIZER MODEL 2905

K982785 · Array Corp. · LMA · Oct 15, 1998 · Radiology

Device Facts

• Record ID: K982785
• Device Name: FILM DIGITIZER MODEL 2905
• Applicant: Array Corp.
• Product Code: LMA · Radiology
• Decision Date: Oct 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

The Laser Film Digitizer is intended for reading black and white images from transmitted light through an X-ray film and the like and transferring the images as the digital data to a computer.

Device Story

The Laser Film Digitizer 2905 is an image scanner designed to convert analog X-ray film images into digital data. The device uses a He-Ne gas laser and a polygonal mirror beam scanning system to read transmitted light through X-ray film. A photomultiplier sensor captures the light, allowing for the reading of high-density films up to 4.0 optical density. The device outputs 12-bit (4096 gray levels) digital data, which is linear to optical density, and transfers this data to a computer via a SCSI-2 interface. It is intended for use in clinical environments where medical radiographs require digitization for computer-based processing or storage. The output allows healthcare providers to view, store, or analyze radiographic images digitally, potentially improving workflow efficiency and image management compared to traditional film-based systems.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Laser film digitizer using He-Ne gas laser and polygonal mirror beam scanning. Features a photomultiplier sensor with 0-4.0 OD dynamic range. Outputs 12-bit gray scale data. Connectivity via SCSI-2 interface. Dimensions: 526x766x330mm; Weight: 45kg. Complies with UL1950, CAN/CSA-C22.2 No.950, EN 60950, EN 60825-1, and 21 CFR Chapter I, Sub-chapter J radiation standards.

Indications for Use

Indicated for scanning medical radiographs with a laser beam and generating a digital electrical signal from the transmitted light.

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

• Lumiscan 50 (K933129)
• Lumiscan 20 (K953964)

Submission Summary (Full Text)

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OCT 1 5 1998

K982785

- 1. Company Identification
Array Corporation 3-42-10 Yovogi, Shibuya-ku, Tokyo 151-0053 Japan Tel : [phone] Fax : [phone]

- 2. Official Correspondent
Takashi Inami Manager Quality Engineering Dept.

- 3. Date of Submission
July 22, 1998

### 4. Device Trade name

2905

#### 5. Common Name

Laser Film Digitizer

### 6. Classification

Medical image digitizers were reviewed by the Radiology Panel and are classified in Class II per 21 CFR 892.2030.

#### 7. Predicate Device

Lumiscan 50, 510(k)# K933129, Lumiscan 20, 510(k)# K953964, manufactured by Lumisys Inc., 225 Humboldt Court, Sunnyvale, California 94089.

### 8. Description of Device

The Laser Film Digitizer 2905 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images as the digital data to a computer. It has the following features:

- (1) Since the 2905 is equipped with a photomultiplier having wide dynamic range as a sensor, it can read high density films, such as a film whose optical density is up to 4.0.
- 2 The 2905 can output 4096 gray levels (12 bits) which are linear to optical density.
- 3) The 2905 can read a film at high speed using laser.
- 4 The interface of the 2905 is SCSI-2, so that it can transfer data at high speed.

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### 9. Intended Use

The Laser Film Digitizer is intended for reading black and white images from transmitted light through an X-ray film and the like and transferring the images as the digital data to a computer.

## 10. Substantial Equivalence to Predicate Device

The 2905 is substantially equivalent to the Lumiscan 50 (K933129) and Lumiscan 20 (K953964), laser film digitizer manufactured by Lumisys Inc., 225 Humboldt Court, Sunnyvale, California Comparison of the principal characteristics of the three devices which are pertinent to 94089. clinical performance is shown below.

| | Array | Lumisys | Lumisys |
|-------------------|-------------------------------------------------------------|----------------|-------------------|
| Product Name | Model 2905 | Lumiscan 50 | Lumiscan 20 |
| 510(k) Number | ... | K933129 | K953964 |
| Dimensions | 526x766x330mm <span style="vertical-align: super;">t</span> | 21x13x27" | 21x13x27" |
| Weight | 45kg | 75lbs. | 75lbs. |
| Power (V ac/A/Hz) | 120/3/50-60 | 110/1/60 | 110/1/60 |
| Scan Size | 14x17" | 14x36" | 14x36" |
| Spot Size | 70μm | 210μm | 175μm |
| Dynamic Range | 0-4.0 OD | 0-4.1 OD | 0-3.8 OD |
| Gray Scale | 12 bits | 12 bits | 12 bits |
| Digitizing Rate | 300 lines/sec. | 115 lines/sec. | 160 lines/sec. |
| Laser | He-Ne Gas Laser | Laser | Solid State Array |
| Beam Scan | Polygonal Mirror | Galvanometer | CCD |
| Pixel per mm | 0.5-20 | 5 | 5.7 |
| Interface | SCSI | SCSI/PC ISA | SCSI/PC ISA |

# 11. Safety Concerns

The Laser Film Digitizer 2905 complies with the following standards (under application for Approvals).

UL1950 CAN/CSA-C22.2 No.950 TUV: EN 60950+A1+A2 EN 60825-1

Additionally, the Laser Film Digitizer 2905 complies with CFR 47, Part 15 and Radiation performance standards (21 CFR Chapter I, Sub-chapter J).

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1998

Takashi Inami Manager, Qaulity Engineering Dept. Array Corporation 3-42-10 Yoyogi, Shibuya-Ku Tokyo 151-0053, Japan

K982785

Re:

2905. Laser Film Digitizer Dated: July 28, 1998 Received: August 7, 1998 Regulatory class: II 21 CFR 892.2030/Procode: 90 LMA

Dear Ms. Inami:

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 devices marketed in interstate commerce prior to May 28, 1976, the ensoment 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 generals on 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 II (Special Controls) or 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 Fectiver one, Title 21, Parts 800 to 895. A substantially equivalent determines compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) 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 80) was additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-468. "Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliances 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/cdrf/dsmaldsmamain.html".

Sincerely yours,

William Yu

Lillian Yin. Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (If known): K982785

Device Name: Laser Film Digitizer 2905

Indications for Use:

The Laser Film Digitizer 2905 is indicated for scanning medical radiographs with a laser beam and generating a digital electrical signal from the transmitted light.

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Concurrence of CDRH, Office of Device Evaluation

David b. Syner
Division Sign-Off

(Division Sign-Off) Division Reproductive, Abdominal, EN and Radiological Devig 510(k) Number

Prescription Use X

OR Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)