(142 days)
K930527/A
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No
The document describes standard image scanning, storage, retrieval, and transmission software for dental radiographs. While it mentions "intelligent scanning module," this term is often used in a broader sense for automated processes and doesn't necessarily indicate AI/ML. There is no mention of AI, ML, deep learning, or any related concepts, nor are there descriptions of training or test sets which are typical for AI/ML-based devices.
No
The device description and intended use indicate that this software is used for viewing, manipulating, organizing, storing, and transmitting dental radiographic images for diagnostic and administrative purposes; it does not provide any form of therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "Radiograph viewing and manipulation for diagnostic purposes" and lists specific conditions (dental caries, periodontal disease, bone loss, tooth fractures, jaw misalignment) that the device will be used to diagnose. Additionally, the 'Device Description' section also mentions "diagnostic review of radiograph images" for TigerView.
No
The device description explicitly states that scanning is accomplished with a commercially available flatbed scanner interfaced to the PC, indicating a hardware component is required for the device's function.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: TigerScan and TigerView are software packages that process and manage radiographic images (X-rays). These images are generated by external devices (scanners or potentially digital X-ray sensors, although the description focuses on scanning film). The software itself does not perform any tests on biological samples.
- Intended Use: While the software is used for diagnostic purposes (viewing and manipulating radiographs to diagnose dental conditions), this is done by interpreting images, not by analyzing biological samples.
The device falls under the category of medical imaging software used for viewing, managing, and transmitting diagnostic images. It is not performing a diagnostic test in vitro.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
TigerScan and TigerView are software packages designed to run on industry standard PCcompatible 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 online database of radiographs organized by patient, and interfaces to practice management systems. In addition to
Mentions image processing
Ture
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K930527/A
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.2010 Medical image storage device.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
KiSS ds I
-- 510(k) SUMMARY --
1
9. Safety and Effectiveness Information
K95537
- 9.1 Submitter: TAU Corporation 983 University Ave., Building C, Suite 102 Los Gatos, CA 95030 (408) 395-9191 APR - 4 1996 Contact Person: John Thomas Gate Prepared: 4 October 1995
- ਤੇ.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 PCcompatible 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 online database of radiographs organized by patient, and interfaces to practice management systems. In addition to
વે. ર 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.
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.
Technological Characteristics 9.6
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 --