(70 days)
Not Found
The Lumisys DICOM TOOLKIT, Imageshare 910, Statview, Dejarnette, Imageshare 910 Film Digitizing Acquisition Station
No
The summary explicitly states "There is no image processing used with this software" and "Mentions AI, DNN, or ML: Not Found". The description focuses on DICOM compatibility and image viewing, not advanced analytical capabilities.
No
The device is described as a DICOM software package for viewing radiological images on a PC and does not mention any therapeutic function.
No
The device is described as a "DICOM software package" that enables a PC to be used as a "Radiological image viewer." It facilitates viewing images from various sources like CT scanners but does not perform any diagnostic analysis itself.
Yes
The device description explicitly states "The Film Express software is a DICOM software package" and the intended use describes it as a "DICOM software package". There is no mention of accompanying hardware being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enable a hospital PC to be used as a radiological image viewer, receiving images from various DICOM conformant devices like scanners, digitizers, and CT scanners. This is focused on displaying and viewing medical images, not on performing tests on biological samples.
- Device Description: The description reinforces that it's a DICOM software package for viewing radiological images.
- No mention of biological samples or testing: There is no indication that this software interacts with or analyzes biological samples (blood, urine, tissue, etc.) or performs any kind of diagnostic test on them.
- Focus on image viewing: The core function described is the viewing of existing radiological images.
IVD devices are specifically designed to perform tests on biological samples to provide information for diagnosis, monitoring, or treatment. This software's function falls outside of that definition.
N/A
Intended Use / Indications for Use
The intended user of this device is a DICOM software package that will enable any hospital PC to be utilized as a Radiological image viewer. This is for use with film Quality scanners, such as the Lumisys, Lumiscan film digitizers, and other DICOM conformant devices such as CT scanners or clinical workstations.
Product codes
Not Found
Device Description
The Film Express software is a software package used for archiving and transmission of radiological images. The intended user of this device is a DICOM software package that will enable any hospital PC with adequate radiographic monitor and enough memory to be utilized with Lumisys, Lumiscan film Quality scanners, and other DICOM conformant devices such as CT scanners or clinical workstations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiological images from film Quality scanners (Lumisys, Lumiscan), CT scanners.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital PC with adequate radiographic monitor and enough memory.
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
Extensive testing of the software package has been performed by programmers, by non-programmers, and by potential customers.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
The Lumisys DICOM TOOLKIT, Imageshare 910, Statview, Dejarnette, Imageshare 910 Film Digitizing Acquisition Station
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
510(k) SUMMARY
- Company Identification 1.1
MAY - 2 1997
Mitra Imaging, Inc. 115 Randal Dr. Waterloo, Ontario, Canada N2V 1C5 Tel: (519) 746-2900 Fax: (519) 746-3745
-
Official Correspondent 1.2
Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA, USA, 94578-1116 -
Date of Submission 1.3
February 21, 1997 -
Device Name 1.4
Classification Name:
, PACS
Common/Usual Name:
Teleradiology System
Proprietary Name:
Film Express
- Substantial Equivalence 1.5
The Film Express software is substantially equivalent to the Lumisys DICOM TOOLKIT, Imageshare 910, or Statview.
1
Device Description and Intended Use 1.6
The intended user of this device is a DICOM software The Intended user of this dovies any hospital PC with adequate package that will enable any nooplar is a radiographic monitor and enough memory to be utilized with Radiologicalimage viewer. This uson as the Lumisys, Lumiscan film Quality scanners, such as the Lambyo, .
digitizers, and other DICOM conformant devices such as CT scanners or clinical workstations.
-
Software Development 1.7
Mitra certifies that the Film Express software is designed, i Mitra centifies that the i minuted according to written developed, tested and valuation identify individuals within the procedures. These processible for developing and approving organization responsible for and testing, validation testing product specifications, county and vesting, and in this product is and fleid maintenance. This command only and does not affect image quality. -
Substantial Equivalence Comparison Chart 1.8
| Specification | Film Express | DICOM Toolkit | Imageshare/FD (910) | Statview/DX |
|---|---|---|---|---|
| Graphical User Interface | Yes | Yes | No | Yes |
| Scanners Supported | Radiological | |||
| Quality scanners, | ||||
| such as Lumisys | ||||
| 20/50/75/85/100/ | ||||
| 150/200 | 50, 75, 150, 200 | 50, 75, 100, 150, 200 | 50, 75, 100 | |
| Patient Demographics | Yes | Yes | Yes | Yes |
| Display Resolution | 1024x768 | 1024x768 | N/A | 800x600, |
| 1024x768, | ||||
| 1280x1024, | ||||
| 1200x1600 | ||||
| Communications | TCP/IP | TCP/IP | TCP/IP | TCP/IP |
| Image Review | Flip/Rotate/Pan/Zoom | Flip/Rotate/Pan/Zoom | Flip/Rotate | Flip/Rotate/Pan/Zoom |
| Temporary Image | ||||
| Storage | Yes | Yes | Yes | Yes |
| Platform | PC | PC | PC | PC |
| JPEG | Yes | No | Yes | No |
| DICOM Basic Printing | Yes | No | No | No |
Substantial Equivalence Comparison Chart (Film Express)
2
Safety and Effectiveness 1.9
In accordance with the provisions of the Safe Medical Device Act of 1990, Mitra Imaging, Inc. is providing a summary of safety and effectiveness information regarding the Film Express software.
General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and indication for use.
The hardware components specified (but not supplied) are all "off the shelf" computer components.
Validation and Effectiveness:
Extensive testing of the software package has been performed by programmers, by non-programmers, and by potential customers. Software is only used for control purposes and has no bearing on image quality. There is no image processing used with this software.
Images that are compressed are properly identified in the image information as being compressed as specified by the DICOM standard. This compression identification remains with the image for the entire life of the image.
Substantial Equivalence:
The Film Express software is a software package used for archiving and transmission of radiological images. The intended use and technological characteristics of the system are similar to the Dejarnette, Imageshare 910 Film Digitizing Acquisition Station. Any differences between the Film Express software and the equivalent device have no significant influence on safety or effectiveness.
Its is our conclusion that there is no software component that we know of in the Film Express software whose failure or latent design flaw would be expected to result in death or injury to a patient.