SONY DKR-700 DIGITAL STILL RECORDER

K961680 · Sony Medical Systems · LMB · Jul 3, 1996 · Radiology

Device Facts

• Record ID: K961680
• Device Name: SONY DKR-700 DIGITAL STILL RECORDER
• Applicant: Sony Medical Systems
• Product Code: LMB · Radiology
• Decision Date: Jul 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2010
• Device Class: Class 1

Intended Use

The Sony DKR-700 Digital Still Recorder is intended for use in the recording of video images obtained from medical imaging systems for purposes such as administration, patient record archival storage and education. For example, the DKR-700 Digital Still Recorder can be utilized for recording images acquired by video cameras, fluoroscopic X-ray systems, angiographic X-ray systems, optical microscopes or other systems which produce a compatible video signal.

Device Story

Electronic device for digital recording of color/B&W still images from analog medical imaging sources; records to Magneto Optical (MO) MiniDisc in compressed or noncompressed modes. Operated by clinicians/technicians in clinical settings; images retrieved via user request for playback on analog video monitors or transmission via SCSI interface to PC/Windows environments. Supports metadata attachment (date, image number, name). Facilitates patient record archival and educational review; improves workflow by enabling digital storage and retrieval of still images from analog video signals.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

General purpose electronic video recorder. Inputs: standard analog video signals. Storage: Magneto Optical (MO) MiniDisc. Connectivity: SCSI interface for PC integration. Accessories: Remote control unit, foot switches. Software: DKR-700 plug-in software.

Indications for Use

Indicated for recording video images from medical imaging systems (e.g., fluoroscopic/angiographic X-ray, video cameras, optical microscopes) for administration, patient record archival, and education.

Regulatory Classification

Identification

A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.

Predicate Devices

• Sony DVR-10 Digital Videocassette Recorder (K913886)
• Sony LVR-5000A/LVS-5000A Laser VideoDisc Recorder/Processor (K921275)

Submission Summary (Full Text)

{0}

K96/680

510(k) Summary

For

Sony DKR-700 Digital Still Recorder

JUL - 3 1996

1. Applicant

Sony Medical Systems Division
Sony Electronics Inc.
3 Paragon Drive
Montvale, NJ 07645

Contact Person: Anthony John Kefalos
Telephone: [phone]
Date Prepared: April 30, 1996

2. Device Name

Proprietary Name: Sony DKR-700 Digital Still Recorder
Common/Usual Name: Digital Still Image Recorder
Classification Name: Accessory to Medical Imaging Devices
Classification Status:

Video recorders have not been classified separately under Section 513 of the Act, but are considered to be accessories to medical imaging devices. The Sony DKR-700 Digital Still Recorder is an accessory to devices such as fluoroscopic X-ray systems (21 CFR 892.1660, Product Code 90JAB) and angiographic X-ray systems (21 CFR 892.1600, Product Code 90IZI) which have been classified as Class II devices and were reviewed by the Radiological Devices Panel.

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# 3. Predicate Devices

- Sony DVR-10 Digital Videocassette Recorder
Sony Medical Systems Division
K913886

- Sony Laser VideoDisc Recording (LVR) System
Sony LVR-5000A/LVS-5000A Laser VideoDisc Recorder/Processor
Sony Medical Systems Division
K921275

# 4. Device Description

The Sony DKR-700 Digital Still Recorder is a general purpose electronic device for digitally recording both color and black and white still images from a variety of analog sources in either a noncompressed or compressed mode to a Sony Magneto Optical (MO) MiniDisc. Recorded images may then be played back from the MO disc and viewed on a standard (analog) video monitor, or may be transmitted via a SCSI interface for importing into a PC/Windows application environment. With the DKR-700, information such as date, image number and image name can be attached to each image. Specific images can then be searched for and retrieved at the user’s request.

The major components of the Sony DKR-700 Digital Still Recorder are the recorder, the recording media and the DKR-700 plug-in software. The RM-C700 Remote Control Unit and foot switches are optional accessories for external control of the device.

# 5. Intended Use

The Sony DKR-700 Digital Still Recorder is intended for use in the recording of video images obtained from medical imaging systems for purposes such as administration, patient record archival storage and education. For example, the DKR-700 Digital Still Recorder can be utilized for recording images acquired by video cameras, fluoroscopic X-ray systems, angiographic X-ray systems, optical microscopes or other systems which produce a compatible video signal.

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# 6. Technological Characteristics

The Sony DKR-700 Digital Still Recorder is intended as an addition to the Sony video recorder product line and has the same purpose and function as the predicate devices identified above. All of these Sony recorders have the same intended use, to record video images generated by medical imaging systems primarily for purposes of patient record archival storage and education.

All of the devices accept standard video signals produced by a wide range of equipment. The primary difference between the Sony DKR-700 and the predicate devices is the recording media used. The Sony DKR-700 uses a magneto-optical disc; the Sony DVR-10, a SMPTE format videocassette; and the Sony LVR System, an optical disc. All of these recording media are widely used in video recording systems for medical applications.

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