(54 days)
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No
The description details standard digital image processing techniques (analog-to-digital conversion, memory processing, line interpolation, digital processing for edge enhancement/inversion) using standard semiconductor technology. There is no mention of AI, ML, training data, or complex algorithms typically associated with AI/ML.
No.
The device converts imaging signals and enhances images; it does not directly treat or diagnose a disease or condition in a patient.
No.
The device is described as a digital image processing system that converts video signals from one format to another for display; it does not perform any diagnostic function itself, but rather facilitates the display of diagnostic images.
No
The device description explicitly states that UpScan 120 is housed in a physical chassis and contains multiple printed wiring assemblies, a power supply, and various electronic circuits (analog-to-digital converters, memory circuits, digital processing circuits, etc.). This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the UpScan 120 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- UpScan 120's Function: The UpScan 120's intended use and description clearly state that it is a digital image processing system designed to convert and enhance medical images from various imaging modalities (X-ray, nuclear medicine, MRI, ultrasound). It processes images of the body, not specimens from the body.
- No Specimen Analysis: There is no mention of the UpScan 120 analyzing any biological specimens. Its function is solely related to the manipulation and display of medical images.
Therefore, the UpScan 120 falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The intended use for UpScan 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 high resolution display monitors or other apparatus requiring a very-high-line rate video signal (e.g., 1023-1049 lines @ 60 frames/second, or 1249 lines @ 50 frames/second). The use of UpScan 120 is indicated whenever the source and destination of a video signal are incompatible due to different line and/or frame rates, and a very-high-line rate video signal is required.
Product codes
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Device Description
UpScan 120 is a digital image processing system that can convert from low-line rate video standard of 525/30 (or 625/25) or high-line rate video standard of 1023-1049/30 (or 1249/25), to very-high-line rate video standard of 1023-1049/60 (or 1249/50), often referred to as "flicker free" or "fast" video. Additionally, UpScan 120 can provide a (pre-)fixed amount of vertical edge enhancement to the output video signal, and can also invert the video image (black reverse white). Housed in a 1 3/4" EIA rack mount chassis, UpScan 120 operates from 100V to 240V AC power.
Mentions image processing
Yes
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
UpScan 120 is intended for use in patient care areas
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)
UpScan 120 was tested to ensure that it meets the appropriate requirements of RS-170 and RS-343A. The data demonstrates that UpScan 120 meets these requirements, as is the case for the predicate devices.
In addition, UpScan 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.
UpScan 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 a bird's head. The bird has a sharp, focused eye and a strong beak. The drawing is simple, with bold lines and minimal shading. 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
Image /page/0/Picture/2 description: The image contains a sequence of handwritten characters. The characters appear to be 'K920450'. The characters are written in a cursive style, with some connections between the letters and numbers. The writing is dark and bold, standing out against the white background.
Summary of Safety and Effectiveness 2.
| 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: | UpScan 120 | |
| | Model Number: | ME-955 | |
| | 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 |
| | K954211 | CrisPics | Merlin Engineering Works |
| Description of the
device: | UpScan 120 is a digital image processing system that can convert from
low-line rate video standard of 525/30 (or 625/25) or high-line rate video
standard of 1023-1049/30 (or 1249/25), to very-high-line rate video
standard of 1023-1049/60 (or 1249/50), often referred to as "flicker free" or
"fast" video. Additionally, UpScan 120 can provide a (pre-)fixed amount of
vertical edge enhancement to the output video signal, and can also invert
the video image (black ⇌ white). Housed in a 1 ¾" EIA rack mount
chassis, UpScan 120 operates from 100V to 240V AC power. | | |
| Intended use of the
device: | The intended use for UpScan 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 high resolution display
monitors or other apparatus requiring a very-high-line rate video signal
(e.g., 1023-1049 lines @ 60 frames/second, or 1249 lines @ 50
frames/second). The use of UpScan 120 is indicated whenever the source
and destination of a video signal are incompatible due to different line
and/or frame rates, and a very-high-line rate video signal is required. | | |
UpScan 120 is intended for use in patient care areas, but is not intended to have any patient contact.
1
Technological characteristics of the device:
UpScan 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). UpScan 120 uses standard SSI/MSI/LSI semiconductor technology.
UpScan 120 utilizes nine basic electronic circuits on the primary printed wiring assembly. They are: input analog video conditioning circuit, analogto-digital conversion circuit, memory circuits, digital video line interpolator circuits, digital processing circuits, various control circuits, digital-toanalog 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. The line interpolator circuits interpolate the output digital bus from the memories, and the digital processing circuits add desired vertical edge enhancement and/or video inversion 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, the line interpolator and the digital-to-analog circuits.
UpScan 120 and one of the predicate devices (Merlin UniScan) are realtime 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 output video at twice the standard frame rate. UpScan 120 and the other predicate device (Merlin CrisPics) are real-time video processing systems designed to provide edge enhancement and/or video inversion for monochrome video signals.
UpScan 120 and all of the predicate devices utilize similar technology to perform their functions. These systems all 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 8bit digital-to-analog converters for the output.
Summary of (nonclinical) performance tests and how their results support a determination of substantial equivalence:
Conclusions drawn from the performance tests:
UpScan 120 was tested to ensure that it meets the appropriate requirements of RS-170 and RS-343A. The data demonstrates that UpScan 120 meets these requirements, as is the case for the predicate devices.
In addition, UpScan 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.
UpScan 120 is electrically compatible with industry standard monochrome video signals. The image quality is preserved (within the limits of standard video technology).
Summary of how the technological characteristics compare to predicate device(s):