(85 days)
Imageshare 910, SIENET CS Camera Server, MergeAPS (MergeMVP), Resource Spooler, VIPStation
Imageshare 910, SIENET CS Camera Server, MergeAPS (MergeMVP), Resource Spooler, VIPStation
No
The description focuses on image routing, spooling, and queue management for printing, with no mention of AI/ML technologies or related concepts like image analysis, pattern recognition, or learning algorithms.
No
The device is described as a "distributable filming management system" that manages print jobs for medical images, routing them to printers. It does not provide any therapeutic function.
No
The device is a print spooler and software for managing and routing medical images to printers, not for analyzing or interpreting medical images to provide diagnostic information.
Yes
The device description explicitly states that the Lasershare Print Spooler and/or Software is designed to run on off-the-shelf, general purpose computing equipment and that the application software is designed for maximum portability across operating systems and hardware platforms. It also refers to it as "application software," indicating it is a software product that utilizes existing hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for managing and routing digital medical images from various imaging modalities (CT, MR, Ultrasound, etc.) to medical printers. This is related to medical imaging and printing, not the analysis of biological samples or substances from the human body.
- Device Description: The description focuses on software and hardware for image handling, spooling, and network communication for printing. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis or monitoring of diseases based on laboratory tests
The device's function is purely related to the management and output of medical images, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Lasershare Print Spooler and/or Software is a distributable filming management system that receives digital images and format control data from various image sources (including, but not limited to, CT scanners, MR scanners, Ultrasound systems, R/F units, Computed and Direct Radiography devices, secondary capture devices, imaging gateways, removable storage media or other imaging sources) connected point to point or via networks. The incoming data formats are standard medical imaging formats or proprietary to the modality source vendor. The Lasershare Print Spooler and/or Software allows the operator to manage print job requests, create filming sessions and route image and patient data to one or more laser film printers, thermal dye sublimation and dry printers and other medical imaging print devices.
Product codes
Not Found
Device Description
Function: The Lasershare Print Spooler is designed to accept images from various modalities or digital image networks and direct images to one or more medical imaging print devices, providing spooling and queue management facilities.
Core technology for the Lasershare Print Spooler is based on, and various software components ported from, the Imageshare 910 Protocol Converter (a predicate device). The Lasershare is a modular system that uses network interfaces for communication between the modules. Network interfaces enable the various modules to reside on local or remote machines.
Physical and Performance Characteristics: The Lasershare Print Spooler and/or Software is designed to run on off-the-shelf, general purpose computing equipment. The application software is designed for maximum portability across operating systems and hardware platforms. Performance of the application software is primarily a function of network load; secondarily a function of the hardware platform's computational speed and finally the performance of the printer(s). Intrinsic performance of the application does not change significantly as it is ported from one operating system to another.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, MR scanners, Ultrasound systems, R/F units, Computed and Direct Radiography devices, secondary capture devices
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Imageshare 910, SIENET CS Camera Server, MergeAPS (MergeMVP), Resource Spooler, VIPStation
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(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
1. 510(k) Summary
510(k) Summary
[As required by 21 CFR 807.92(c)]
K963861
EC 1 8 1996
1.0 Submitter Information
- DeJarnette Research Systems 1.2 Wayne T. DeJarnette, Ph.D. 1.1 Contact: 401 Washington Avenue Suite 700 Voice: +1 (410) 583 - 0680 Towson MD 21204 Fax: +1 (410) 583 - 0696 E-mail: info(@dejarnette.com
- 24 September 1996 1.3 Date Prepared:
2.0 Device Identification
- Lasershare Print Spooler and/or Software 2.1 Trade Name:
- Digital Imaging Network Spooler 2.2 Common Name:
- System, Digital Image Communication, accessory 2.3 Classification Name:
Predicate Devices 3.0
Imageshare 910 [DeJarnette Research Systems, Inc.] SIENET CS Camera Server [Siemens Medical Systems, Inc.] MergeAPS (MergeMVP) [Merge Technologies, Inc.] Resource Spooler [Analogic Corporation] VIPStation [CEMAX, Inc.]
4.0 Device Description
- Function: 4.1
The Lasershare Print Spooler is designed to accept images from various modalities or digital image networks and direct images to one or more medical imaging print devices, providing spooling and queue management facilities.
Core technology for the Lasershare Print Spooler is based on, and various software components ported from, the Imageshare 910 Protocol Converter (a predicate device). The Lasershare is a modular system that uses network interfaces for communication between the modules. Network interfaces enable the various modules to reside on local or remote machines.
- 4.2 Physical and Performance Characteristics:
The Lasershare Print Spooler and/or Software is designed to run on off-the-shelf, general purpose computing equipment. The application software is designed for maximum portability across operating systems and hardware platforms. Performance of the application software is primarily a function of network load; secondarily a function of the hardware platform's computational speed and finally the performance of the printer(s). Intrinsic performance of the application does not change significantly as it is ported from one operating system to another.
1
5.0 Intended Use:
The Lasershare Print Spooler and/or Software is a distributable filming management system that receives digital images and format control data from various image sources (including, but not limited to, CT scanners, MR scanners, Ultrasound systems, R/F units, Computed and Direct Radiography devices, secondary capture devices, imaging gateways, removable storage media or other imaging sources) connected point to point or via networks. The incoming data formats are standard medical imaging formats or proprietary to the modality source vendor. The Lasershare Print Spooler and/or Software allows the operator to manage print job requests, create filming sessions and route image and patient data to one or more laser film printers, thermal dye sublimation and dry printers and other medical imaging print devices.
Statement of Substantial Equivalence: 6.0
The Lasershare Print Spooler and/or Software is substantially equivalent to previously marketed devices (as listed above in Part 3) in design, composition, intended use, safety and efficacy.
Any differences between the Lasershare Print Spooler and/or Software and the predicate devices have no significant influence on safety or efficacy.