← Product Code [LMB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB) · K955237 # TIGERSCAN/TIGERVIEW (K955237) _Tau Corp. · LMB · Apr 4, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K955237 ## Device Facts - **Applicant:** Tau Corp. - **Product Code:** [LMB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB.md) - **Decision Date:** Apr 4, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2010 - **Device Class:** Class 1 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Intended Use Scanning of film and archival storage for on-line access by patient. Electronic transmission of digital radiographs with insurance claims. Radiograph viewing and manipulation for Insurance claims adjudication. Radiograph viewing and manipulation for diagnostic purposes. Radiograph viewing for patient education and consultation. Electronic transmission of radiographs to specialists for consultation. ## Device Story TigerScan and TigerView are software packages for PC-compatible computers; convert dental film radiographs to digital format via flatbed scanner. TigerScan: office administrator use; automated scanning for insurance claim submission; deletes images post-transmission. TigerView: comprehensive system; includes database, image manipulation, and practice management integration. Both systems enable electronic transmission of images to specialists/insurers. Clinicians use high-resolution displays for diagnostic review, patient consultation, and insurance adjudication. Digital workflow improves efficiency in image storage, retrieval, and specialist consultation. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Software-based system for PC; utilizes flatbed scanner for image acquisition, modem for transmission, and GUI for display/manipulation. Operates on industry-standard PC hardware. No specific materials or sterilization required as software-only/peripheral-based system. ## Regulatory Identification A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory. ## Predicate Devices - Dental Link ([K930527](/device/K930527.md)/A) ## 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} K955251 # -- 510(k) SUMMARY -- APR - 4 K955257 ## 9. Safety and Effectiveness Information ### 9.1 Submitter: TAU Corporation 983 University Ave., Building C, Suite 102 Los Gatos, CA 95030 (408) 395-9191 Contact Person: John Thomas Date Prepared: 4 October 1995 APR - 4 1996 ### 9.2 Device Name: TigerScan / TigerView ### 9.3 Equivalent Device: Dental Link, FDA registration number K930527/A ### 9.4 Device Description TigerScan and TigerView are software packages designed to run on industry standard PC-compatible computers. This software is designed to support; dental radiograph scanning to convert film to digital form, storage and retrieval of radiographs by patient, electronic transmission to specialists and insurance companies, and diagnostic review of radiograph images. With TigerScan and TigerView, scanning is accomplished with a commercially available flatbed scanner interfaced to the PC. The difference between the two products is: TigerScan is designed exclusively for the electronic submission of radiographs in support of dental insurance claims. Designed to be used by the office administrator, the software is simple and easy to use in an standardized scan, quick review, transmit sequence. TigerScan’s intelligent scanning module insures that diagnostic image quality is maintained and requires little or no operator intervention. When using TigerScan, radiographs are deleted immediately after they are successfully sent to their destination, images are not retained in a database for later review. TigerView is a fully functional digital radiograph scanning, archive, electronic transmission, and diagnostic review system. Features include; advanced graphical user interface, intelligent scanning, scanning and display of full-mouth sets and other mounts, high-resolution image display and manipulation, electronic transmission and receipt of digital radiographs, large on-line database of radiographs organized by patient, and interfaces to practice management systems. In addition to ### 9.5 Intended Use Uses for TigerScan and TigerView in the dental industry include the following: - Scanning of film and archival storage for on-line access by patient. - Electronic transmission of digital radiographs with insurance claims. - Radiograph viewing and manipulation for Insurance claims adjudication - Radiograph viewing and manipulation for diagnostic purposes. - Radiograph viewing for patient education and consultation. - Electronic transmission of radiographs to specialists for consultation. 20 {1} When used for diagnostic purposes, the patient population will be the general public, and the diseases / conditions that the device will be used to diagnose are; dental caries, periodontal disease and bone loss, tooth fractures, jaw misalignment, and other diseases and conditions that are encountered by general practitioners and specialists in the dental care field. ## 9.6 Technological Characteristics TigerScan and TigerView have the same technological characteristics as the predicate device, Dental Link. A summary of the technologies employed in these devices follows: | Technology | Use in Device | | --- | --- | | Image Scanner | Conversion of film to digital image. | | Personal Computer | Control of scanner; storage, retrieval, transmission, and receipt of digital images. | | Graphical User Interface | Mouse, windows, menus, etc. used to control device. | | Modem | Transmission of digital images over phone lines. | | Image Processing | Image display and manipulation. | -- End of 510(k) SUMMARY -- --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K955237](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K955237) **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. 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