← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K970402 # DOCTORS REVIEW SYSTEM (K970402) _Digisonics, Inc. · LLZ · Mar 26, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K970402 ## Device Facts - **Applicant:** Digisonics, Inc. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Mar 26, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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. 10-1 3701 Kirby Drive • Houston, Texas 77098 • Telephone: (713) 529-7979 • (800) 940-3240 • Telefax: (713) 529-7999 {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. 10-2 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K970402](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K970402) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com