(60 days)
No
The device description focuses on standard digital signal processing techniques for video format conversion, without mentioning AI or ML algorithms.
No
The device is a digital image processing system that converts video signals for display and does not directly provide therapeutic benefits.
No
The device is an image processing system designed to convert video signals to compatible formats for display or recording. It does not perform diagnostic functions such as analyzing images for medical conditions or providing medical interpretations.
No
The device description explicitly details a physical chassis, printed wiring assemblies, a power supply, and various electronic circuits (analog-to-digital converter, memory circuits, etc.), indicating it is a hardware device with embedded software for image processing.
Based on the provided information, the DownScan 120 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- DownScan 120's Function: The DownScan 120's intended use is to convert and process medical images from various imaging modalities (X-ray, nuclear medicine, MRI, ultrasound). It deals with the display and recording of these images, not the analysis of biological specimens.
- No Specimen Handling: The description explicitly states that the device is "not intended to have any patient contact." This further reinforces that it does not handle or analyze biological samples.
The DownScan 120 is a medical device, but it falls under the category of image processing and display equipment, not IVD.
N/A
Intended Use / Indications for Use
The intended use for DownScan 120 is conversion of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and ultrasound images either directly from their source, or from an intermediate storage device (like a video tape or video disk), for use on display monitors, optical, tape or disk recorders, or other apparatus requiring a standard frame rate video signal (30 or 25 frames/second). The use of DownScan 120 is indicated whenever the source and destination of a video signal are incompatible due to different line and/or frame rates, and a standard frame rate video signal is required. DownScan 120 is intended for use in patient care areas, but is not intended to have any patient contact.
Product codes
Not Found
Device Description
DownScan 120 is a digital image processing system that can convert from very-high-line rate video standard of 1023-1049/60 or 1249/50 (~64 KHz horizontal frequency, often referred to as "flicker free" or "fast" video) to high-line rate video standards of 1023-1049/30 or 1249/25, or to low-line rate video standards of 525/30 or 625/25. Housed in a 1 3/4" EIA rack mount chassis, DownScan 120 operates from 100V to 240V AC power.
Mentions image processing
DownScan 120 is a digital image processing system
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and ultrasound images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient care areas
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
DownScan 120 was tested to ensure that it meets the appropriate requirements of RS-170 and RS-343A. The data demonstrates that the DownScan 120 meets these requirements, as is the case for the predicate device.
In addition, DownScan 120 was tested in accordance with SMPTE RP-133.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
DownScan 120 was tested to ensure that it meets the appropriate requirements of RS-170 and RS-343A. The data demonstrates that the DownScan 120 meets these requirements, as is the case for the predicate device.
In addition, DownScan 120 was tested in accordance with SMPTE RP-133. The system correctly compensates for aspect ratio changes, and it permits low-contrast imaging resolution at the 1% level.
DownScan 120 is electrically compatible with industry standard monochrome video signals. The image quality is preserved (within the limits of standard video technology).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image is a black and white drawing of an eagle's head. The eagle is facing forward, and its eye is visible. The eagle's feathers are detailed, and the background is a solid black circle. The text "Keen of Eye, Swift of Wing" is at the bottom of the image.
Merlin Engineering Works 1888 Embarcadero Road, Palo Alto, CA 94303 Tel (415) 856-0900 Fax (415) 858-2302
| 2. | Summary of Safety and Effectiveness APR - 7 1997 | ||
|---|---|---|---|
| Submitter: | Merlin Engineering Works, Inc. | ||
| 1888 Embarcadero Road | |||
| Palo Alto, California 94303 | |||
| Telephone: | (415) 856-0900 | ||
| Facsimile: | |||
| (415) 858-2302 | |||
| Contact: | Gerald Engbretson, Operations Manager / Director, Regulatory | ||
| Affairs | |||
| Device identification: | Trade Name: | DownScan 120 | |
| Model Number: | ME-954 | ||
| Common Name: | Video Scan Converter (or Digital Scan Converter) | ||
| Classification | |||
| Name: | (A component of) stationary x-ray system, per 21 | ||
| CFR 892.1689 (or equivalent) | |||
| Device(s) to which | |||
| substantial equivalence | |||
| is claimed: | K953398 | UniScan | Merlin Engineering Works |
| Description of the | |||
| device: | DownScan 120 is a digital image processing system that can convert from | ||
| very-high-line rate video standard of 1023-1049/60 or 1249/50 (~64 KHz | |||
| horizontal frequency, often referred to as "flicker free" or "fast" video) to | |||
| high-line rate video standards of 1023-1049/30 or 1249/25, or to low-line | |||
| rate video standards of 525/30 or 625/25. Housed in a 1 3/4" EIA rack | |||
| mount chassis, DownScan 120 operates from 100V to 240V AC power. | |||
| Intended use of the | |||
| device: | The intended use for DownScan 120 is conversion of X-ray (stationary, | ||
| C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and | |||
| ultrasound images either directly from their source, or from an | |||
| intermediate storage device (like a video tape or video disk), for use on | |||
| display monitors, optical, tape or disk recorders, or other apparatus | |||
| requiring a standard frame rate video signal (30 or 25 frames/second). | |||
| The use of DownScan 120 is indicated whenever the source and | |||
| destination of a video signal are incompatible due to different line and/or | |||
| frame rates, and a standard frame rate video signal is required. | |||
| DownScan 120 is intended for use in patient care areas, but is not | |||
| intended to have any patient contact. |
. . . . . . . . . . .
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Technological characteristics of the device:
Summary of how the technological characteristics compare to predicate device(s):
Summary of (nonclinical) performance tests and how their results support a determination of substantial equivalence:
Conclusions drawn from the performance tests:
DownScan 120 consists of an enclosed sheet metal chassis housing one main printed wiring assembly, one secondary printed wiring assembly, and the power supply (100-240 VAC input and ±15 VDC, ±5 VDC outputs). DownScan 120 uses standard SSI/MSI/LSI semiconductor technology.
DownScan 120 utilizes eight basic electronic circuits on the primary printed wiring assembly. They are: input analog video conditioning circuit, analog-to-digital conversion circuit, memory circuits, various control circuits, digital-to-analog conversion circuit, two clock circuits, and output analog video conditioning circuit.
All of the processing is done in the digital domain. The analog-to-digital converter changes the analog video to an 8-bit digital bus. That digital bus is sent to the memories for processing. Memory control circuits manage the locations and the timing of how the video is being stored in the memories and then read from memory before sending the resultant signal to the 8-bit digital-to-analog circuit.
The write clock generator provides clock timing for analog-to-digital conversion, the memories and the memory control circuits. The read clock generator provides read clock timing for the memories and the digital-to-analog circuits.
DownScan 120 and the predicate device are real-time video processing systems which are designed to convert monochrome video images from one video format to another. The only differences are a higher clock frequency and the ability to input video at twice the standard frame rate.
DownScan 120 and the predicate device utilize similar technology to perform their functions. These systems both convert the incoming analog video signal to digital form using 8-bit analog-to-digital converters, process the signals in the digital domain, and convert back to analog video using 8-bit digital-to-analog converters for the output.
DownScan 120 was tested to ensure that it meets the appropriate requirements of RS-170 and RS-343A. The data demonstrates that the DownScan 120 meets these requirements, as is the case for the predicate device.
In addition, DownScan 120 was tested in accordance with SMPTE RP-133. The system correctly compensates for aspect ratio changes, and it permits low-contrast imaging resolution at the 1% level.
DownScan 120 is electrically compatible with industry standard monochrome video signals. The image quality is preserved (within the limits of standard video technology).