TIGERSCAN/TIGERVIEW

K955237 · Tau Corp. · LMB · Apr 4, 1996 · Radiology

Device Facts

• Record ID: K955237
• Device Name: TIGERSCAN/TIGERVIEW
• Applicant: Tau Corp.
• Product Code: LMB · Radiology
• Decision Date: Apr 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2010
• Device Class: Class 1
• 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.

Indications for Use

Indicated for the general public for the diagnosis of dental caries, periodontal disease, bone loss, tooth fractures, jaw misalignment, and other dental conditions encountered by general practitioners and specialists.

Regulatory Classification

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/A)

Submission Summary (Full Text)

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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
[phone]

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.

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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 --