(87 days)
Intrascan, Instrascan II
Not Found
No
The description focuses on basic image capture, storage, and display functionalities, with no mention of AI/ML terms or capabilities like automated analysis, pattern recognition, or predictive features.
No
The device is described as an archiving system for recording, storage, and presentation of video ultrasound images. It does not provide any therapy or treatment.
No
The device is described as an archiving system for recording, storage, and presentation of video ultrasound images. Its functions revolve around managing images from FDA approved ultrasound equipment, not interpreting or analyzing them for diagnostic purposes.
No
The device description explicitly states it is a "software controlled microprocessor based archiving system" and describes its connection to an "IBM-compatible personal computer (PC)" and the use of a "CD-ROM" and "printer(s)". This indicates the device includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device, uPACS, is an archiving system for video ultrasound images. It captures, stores, and presents images obtained directly from an ultrasound scanner.
- The intended use and device description clearly state its function is related to managing and displaying medical images, not analyzing biological samples.
The device's purpose is to handle and manage imaging data, which falls under the category of medical imaging devices or picture archiving and communication systems (PACS), not in vitro diagnostics.
N/A
Intended Use / Indications for Use
uPACS™ 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 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 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.
In the uPACS standard configuration, an FDA approved ultrasound imaging device (scanner) is connected to an IBM-compatible personal computer (PC). Images captured by the scanner 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 an FDA approved printer by the PC.
uPACS enables users to perform the following system functions:
- View live images from user provided FDA approved ultrasound scanners or other ન્દ્રન NTSC or PAL video sources;
- Capture single-frame images from ultrasound scanners or other NTSC or PAL video sources;
- 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; ન્દ્ર
- Display up to four images at a time for review;
- Place notations directly on images;
- Archive images using CD-ROM;
- Export images to diskette 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video ultrasound images, NTSC or PAL video sources
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient environement
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The determination of substantial equivalence is not based on an assessment of performance data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Intrascan, Instrascan II
Reference Device(s)
Not Found
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
Cacao
510(k) Summary (In accordance with 21 CFR 807.92) Device: uPACS™
JUN - 3 1996
1. Submittals:
A.
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
Name of Device: 2.
Trade or Proprietary Name: uPACSTM
Company or Usual Name: Picture Archiving System (Established Name)
Classification Name:
Device, Digital Image Storage - 90LMB Digitzer, 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 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 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.
In the uPACS standard configuration, an FDA approved ultrasound imaging device (scanner) is connected to an IBM-compatible personal computer (PC). Images captured by
1
the scanner 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 an FDA approved printer by the PC.
uPACS enables users to perform the following system functions:
- View live images from user provided FDA approved ultrasound scanners or other ન્દ્રન NTSC or PAL video sources;
-
- Capture single-frame images from ultrasound scanners or other NTSC or PAL video sources;
- નું 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; ન્દ્ર
- ન્દ્રન Display up to four images at a time for review;
- 彩 Place notations directly on images;
- નું. Archive images using CD-ROM;
- 必 Export images to diskette and user provided printer(s);
- જુન Provide a means for user training and proficiency demonstration;
-
- Assign security privileges to specific users in accordance with clinical access criteria.
Intended Use Statement: 5.
uPACS™ 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™ Device are essentially the same as that of the predicate device.
- B. The determination of substantial equivalence is not based on an assessment of performance data.