(51 days)
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No
The description focuses on word processing, data review, menu-based input, and basic analysis/search functions, with no mention of AI/ML terms or capabilities.
No
The 'Intended Use / Indications for Use' section explicitly states, "It is not used for therapy or patient monitoring."
No
The software's intended use explicitly states, "No diagnoses are made by the software," and it is used for "creating patient reports" and reviewing data.
No
The device is described as consisting of software together with off-the-shelf computer equipment (PC, VCR, printer, etc.) and is sold either as software alone or as software together with PC based computer parts. While a software-only option exists, the description explicitly includes hardware components as part of the overall system being described and cleared.
Based on the provided information, the Doctors Review System (DRS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- DRS Function: The DRS is described as general-purpose software for creating patient reports by reviewing data from other sources and noting clinical observations. It does not directly analyze biological specimens.
- No Diagnostic Claims: The description explicitly states, "No diagnoses are made by the software."
- Focus on Reporting and Data Management: The primary function is report generation, data management, and optional analysis of existing data (echo and cath lab data), not the analysis of in vitro samples.
While the system handles patient data and can include image management, its core purpose is not the in vitro examination of biological specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Doctors Review System (DRS) is general purpose, standalone software for creating patient reports. It consists of Digisonics word processing software together with off-the-shelf computer equipment (PC, VCR, printer, etc.). Using the system, the physician reviews data (from other sources), notes clinical observations from sets of menus, and creates patient reports. Optional analysis programs are provided for quantitation of echo and cath lab data. No diagnoses are made by the software. It is not used for therapy or patient monitoring.
Product codes
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Device Description
The Doctors Review System (DRS) is general purpose, standalone software for creating patient reports. It consists of Digisonics word processing software together with off-the-shelf computer equipment (PC, VCR, printer, etc.). Using the system, the physician reviews data (from other sources), notes clinical observations from sets of menus, and creates patient reports. Optional analysis programs are provided for quantitation of echo and cath lab data. No diagnoses are made by the software. It is not used for therapy or patient monitoring.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
The review system is used by radiologists, cardiologists, obstetricians and gynecologists. The device is used in hospitals, outpatient clinics, and other clinical environments that need efficient review and reporting systems.
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
Testing was performed according to internal company procedures. Software verification and validation was done at the module, integration and system level according to written test protocols established before testing was conducted.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation and verification results support the conclusion that the software performance satisfies all functional and system specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/0 description: The image shows the word "DIGISONICS" in a bold, sans-serif font. To the left of the word is a graphic consisting of several rows of small, filled triangles. The triangles are arranged in a grid-like pattern, with the size of the triangles decreasing from left to right.
x970402
MAR 26 1997
510(k) SUMMARY
Doctors Review System
Name of Submitter:
Digisonics, Inc. 3701 Kirby Drive Houston, TX 77098 713-529-7979 713-529-7999 (Fax)
Contact Person:
Diana McSherry, CEO
Date of Summary:
January 27, 1997
Device and Common Names:
Device Proprietary Name: Doctors Review System Common Name: Review and Reporting System
Device Description:
Indications for Use
The Doctors Review System (DRS) is general purpose, standalone software for creating patient reports. It consists of Digisonics word processing software together with off-the-shelf computer equipment (PC, VCR, printer, etc.). Using the system, the physician reviews data (from other sources), notes clinical observations from sets of menus, and creates patient reports. Optional analysis programs are provided for quantitation of echo and cath lab data. No diagnoses are made by the software. It is not used for therapy or patient monitoring.
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1
User Characteristics
The review system is used by radiologists, cardiologists, obstetricians and gynecologists. The device is used in hospitals, outpatient clinics, and other clinical environments that need efficient review and reporting systems.
General Description
The Doctors Review System is sold either as software alone or as software together with PC based computer parts. The device is available in a variety of configurations, reflecting specific requirements of different specialities. An optional Search package is also available. This program searches the data base of stored reports and list those studies matching the search criteria specified. Links to a variety of ultrasound systems are available as options. The new digital image management option for capturing and displaying digital data is also available as an add-on to the various configurations.
Substantial Equivalence
The Doctors Review System is substantially equivalent to the following systems which are currently marketed:
- · ATL Nova Microsonics Image Vue DCR System
- · TomTec TomTec 90 with Echocardiography Offline Review
- · General Electric RT 4000 Data Management Center
- · On-Time Medical Click*View
All of these devices include review and reporting capabilities. The first two devices include cardiology analysis and digital image management options. The last two devices include obstetrics/gynecology calculations.
Test Discussion:
Testing was performed according to internal company procedures. Software verification and validation was done at the module, integration and system level according to written test protocols established before testing was conducted. Test results are reviewed by designated professionals before software is approved for release.
Test Conclusions:
Validation and verification results support the conclusion that the software performance satisfies all functional and system specifications.