(63 days)
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No
The description focuses on digital recording and playback of still images from analog sources, with features for organization and retrieval. There is no mention of AI or ML technologies for image analysis, interpretation, or other functions.
No
The device is a digital still recorder intended for recording video images from medical imaging systems for administrative, archival, and educational purposes, not for treating or diagnosing patients.
No
This device is described as a "Digital Still Recorder" that 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." It records and plays back images; it does not analyze or interpret images for diagnostic purposes. Its stated function is for "archival storage and education," not diagnosis.
No
The device description explicitly states that the device is a "general purpose electronic device" with "major components" including a "recorder" and "recording media" (Magneto Optical MiniDisc), in addition to the "DKR-700 plug-in software." This indicates the device is a hardware system with accompanying software, not a software-only device.
Based on the provided information, the Sony DKR-700 Digital Still Recorder is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for recording video images obtained from medical imaging systems for purposes like administration, patient record archival storage, and education. This is related to managing and storing medical images, not performing diagnostic tests on biological samples.
- Device Description: The device is described as a general-purpose electronic device for digitally recording still images from analog sources. It focuses on image capture, storage, and retrieval.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. The Sony DKR-700's function is to record and manage images generated by other medical imaging systems.
N/A
Intended Use / Indications for 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.
Product codes
90JAB, 90IZI
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
video cameras, fluoroscopic X-ray systems, angiographic X-ray systems, optical microscopes, or other systems which produce a compatible video signal.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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.
2
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.