(63 days)
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.
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.
The provided text describes a medical device, the Sony DKR-700 Digital Still Recorder, and its intended use, but it does not contain information about acceptance criteria, a study proving device performance, or any of the detailed metrics requested in your prompt.
The document is a 510(k) summary, which is a premarket notification submitted to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. This type of submission typically focuses on technological characteristics and equivalence to predicate devices rather than detailed performance studies with acceptance criteria, ground truth, or expert review panels.
Therefore, I cannot populate the table or answer the specific questions about performance studies, sample sizes, experts, or ground truth with the information provided. The document outlines:
- Device Name: Sony DKR-700 Digital Still Recorder
- Intended Use: Recording video images from medical imaging systems for administration, patient record archival, and education. It's an accessory to various medical imaging devices.
- Predicate Devices: Sony DVR-10 Digital Videocassette Recorder and Sony Laser VideoDisc Recording (LVR) System.
- Technological Characteristics: Records digital still images from analog sources to a Sony Magneto Optical (MO) MiniDisc, with playback and SCSI interface for PC integration. The primary difference from predicates is the recording media.
To answer your questions, I would need a different type of document, such as a clinical study report, a validation study, or a performance testing protocol, which are not present in this 510(k) summary.
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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
Anthony John Kefalos Contact Person: 201-358-4330 Telephone:
Date Prepared: April 30, 1996
Device Name 2.
| Proprietary Name: | Sony DKR-700 Digital Still Recorder |
|---|---|
| Common/Usual Name: | Digital Still Image Recorder |
| Classification Name: | Accessory to Medical Imaging Device |
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
Device Description 4.
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.
§ 892.2010 Medical image storage device.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.