DOCTORS REVIEW SYSTEM

K970402 · Digisonics, Inc. · LLZ · Mar 26, 1997 · Radiology

Device Facts

• Record ID: K970402
• Device Name: DOCTORS REVIEW SYSTEM
• Applicant: Digisonics, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Mar 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Standalone software system for clinical report generation; inputs include data from external sources (echo/cath lab) and manual clinical observations via menu selection; optional modules for echo/cath lab data quantitation and digital image management; operates on PC-based hardware; used by physicians (radiologists, cardiologists, OB/GYN) in hospitals/clinics; facilitates efficient review and reporting; does not provide automated diagnosis, therapy, or patient monitoring; includes database search functionality for stored reports.

Clinical Evidence

Bench testing only. Software verification and validation performed at module, integration, and system levels per internal protocols. Results confirmed software performance satisfies functional and system specifications.

Technological Characteristics

Standalone software; PC-based hardware; optional digital image management and database search modules; connectivity via links to ultrasound systems; menu-driven reporting interface; quantitation algorithms for echo/cath lab data.

Indications for Use

Indicated for use by radiologists, cardiologists, obstetricians, and gynecologists in hospitals, outpatient clinics, and clinical environments for patient report creation and data review.

Regulatory Classification

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.

Special Controls

*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).

Reference Devices

• 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

Submission Summary (Full Text)

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DIGISONICS
K970402
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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3701 Kirby Drive • Houston, Texas 77098 • Telephone: [phone] • [phone] • Telefax: [phone]

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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.

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