(81 days)
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No
The document describes a standard PACS system for archiving and presenting ultrasound images, with no mention of AI or ML capabilities.
No.
The device is described as an "archiving system for recording, storage and presentation of video ultrasound images," which points to a data management function rather than directly treating a condition or disease.
No
Explanation: The device is an archiving system for video ultrasound images, not an imaging device itself. Its purpose is storage and presentation, not diagnosis. This system "is designed for connection to and use with FDA cleared ultrasound imaging equipment which provides video output." This indicates that it does not create the images or perform diagnostic functions.
No
The device description explicitly states it is a "software controlled microprocessor based archiving system," indicating the presence of hardware (microprocessor) in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The uPACS™ Version 1.7 system is described as an archiving system for video ultrasound images. It captures, stores, and presents these images.
- Lack of biological sample analysis: The description does not mention any analysis of biological samples. The system works with images generated by ultrasound equipment, which is an imaging modality, not a diagnostic test performed on a biological specimen.
Therefore, the function of this device falls outside the scope of an In Vitro Diagnostic. It is a medical image management and archiving system.
N/A
Intended Use / Indications for Use
uPACS™ Version 1.7 is a software controlled microprocessor based archiving system using installed proprietary software for recording, storage and presentation of video ultrasound images. The system is designed for use with FDA approved ultrasound imaging equipment which provides video output and is approved for operation and use in the patient environement.
Product codes
90LMB, 90LMA
Device Description
uPACS Version 1.7 is a software controlled microprocessor based archiving system using installed proprietary software for capturing, storage, archiving and presentation of video ultrasound images. The system is designed for connection to and use with FDA cleared ultrasound imaging equipment which provides video output and is cleared for operation and use in the patient environment. uPACS Version 1.7 can also accept images stored on magneto-optical (MO) disks, captured remotely, in video output form.
In the standard uPACS Version 1.7 configuration, an FDA cleared ultrasound imaging device (scanner) is connected to an IBM-compatible personal computer (PC) or to a remote capture unit (not part of the uPACS Version 1.7 system) which stores but does not archive images on an MO disk. Images captured by the scanner, or captured remotely and imported to uPACS Version 1.7 on an MO disk, are displayed on the monitor of the PC along with any text that is typed on the PC keyboard. The ultrasound image and patient text data can be stored on a CD-ROM in the PC, and images can be exported to a medical quality printer by the PC.
uPACS Version 1.7 enables users to perform the following system functions:
- View live images from user provided FDA approved ultrasound scanners or other NTSC or PAL video sources;
- Capture single-frame images from ultrasound scanners or other NTSC or PAL video sources;
- Import images, captured remotely, on an MO disk;
- Obtain text data directly from captured images;
- Edit text and image data before permanent storage;
- Review stored images on the system and on CD-ROM;
- Display up to four images at a time for review;
- Place notations directly on images;
- Archive images using CD-ROM;
- Export images to diskette, MO disk, and user provided printer(s);
- Provide a means for user training and proficiency demonstration;
- Assign security privileges to specific users in accordance with clinical access criteria.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
video ultrasound images, NTSC or PAL video sources
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
The determination of substantial equivalence is not based on an assessment of performance data.
Key Metrics
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Predicate Device(s)
Intrascan, Instrascan II
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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) Summarv (In accordance with 21 CFR 807.92) Device: uPACS™ Version 1.7
Image /page/0/Picture/1 description: The image shows a series of characters written in black ink on a white background. The characters appear to be handwritten and include the letters 'K' and 'O', as well as the number '1'. The overall style is somewhat rough and informal, resembling a quick sketch or note.
JUN || 199
1. Submittals:
Base Ten Systems, Inc. One Electronics Drive Trenton, New Jersey 08619-0151 Voice: (609) 586-7010 Fax: (609) 586-1593 Contact Person: Richard J. Farrelly Date of Preparation: 13 May 1996
2. Name of Device:
Trade or Proprietary Name: uPACSTM Version 1.7
Company or Usual Name: Picture Archiving System (Established Name)
Classification Name:
Device, Digital Image Storage - 90LMB Digitzers, Image - 90LMA
3. Predicate Devices:
Intrascan
and
Instrascan II
Manufactured by:
Mark Solutions, Inc. Mark Care Medical Systems, Inc. 87 Route 17 North Maywood, New Jersey 07607 Telephone: (201) 368-8118
4. Device Description:
uPACS Version 1.7 is a software controlled microprocessor based archiving system using installed proprietary software for capturing, storage, archiving and presentation of video ultrasound images. The system is designed for connection to and use with FDA cleared ultrasound imaging equipment which provides video output and is cleared for operation and use in the patient environment. uPACS Version 1.7 can also accept images stored on magneto-optical (MO) disks, captured remotely, in video output form.
A.
1
In the standard uPACS Version 1.7 configuration, an FDA cleared ultrasound imaging device (scanner) is connected to an IBM-compatible personal computer (PC) or to a remote capture unit (not part of the uPACS Version 1.7 system) which stores but does not archive images on an MO disk. Images captured by the scanner, or captured remotely and imported to uPACS Version 1.7 on an MO disk, are displayed on the monitor of the PC along with any text that is typed on the PC keyboard. The ultrasound image and patient text data can be stored on a CD-ROM in the PC, and images can be exported to a medical quality printer by the PC.
uPACS Version 1.7 enables users to perform the following system functions:
- View live images from user provided FDA approved ultrasound scanners or other જી NTSC or PAL video sources;
- Capture single-frame images from ultrasound scanners or other NTSC or PAL 参 video sources;
- જુન Import images, captured remotely, on an MO disk;
- Obtain text data directly from captured images; જુન
- જુન Edit text and image data before permanent storage;
- જ્ઞ Review stored images on the system and on CD-ROM;
- જુન Display up to four images at a time for review;
- જી Place notations directly on images;
- જુન Archive images using CD-ROM;
ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
- જુઓ Export images to diskette, MO disk, and user provided printer(s);
- જુન Provide a means for user training and proficiency demonstration;
- જી Assign security privileges to specific users in accordance with clinical access criteria.
2
Intended Use Statement: ક.
uPACS™ Version 1.7 is a software controlled microprocessor based archiving system using installed proprietary software for recording, storage and presentation of video ultrasound images. The system is designed for use with FDA approved ultrasound imaging equipment which provides video output and is approved for operation and use in the patient environement.
-
- The technological characteristics of the uPACS™ Version 1.7 Device are essentially the same as that of the predicate device.
- The determination of substantial equivalence is not based on an assessment of performance data. B.