K Number

Device Name

DEXIS Webview

Manufacturer

Imaging Sciences International /Gendex/Dexis

Date Cleared

2015-10-07

(85 days)

Product Code

LLZ

Regulation Number

892.2050

Intended Use

Dexis Webview is a web-based software used for general dental and maxillofacial diagnostic image review that allows users alternate access to image data using a common web-browser. It provides the ability to view, enhance, annotate, compare, and export images by accessing an existing image database available in a distributed environment. Dexis Webview is indicated for use only by prescription and by a trained and qualified dentist or dental technician.

Device Description

Dexis Webview is a web browser-based accessory software application that allows users to access preexisting imaging data remotely. Users are able to view, enhance, annotate, compare, and export preexisting images using the Dexis Core database using a web-browser. The intended use of the device is to allow dentists to be able to diagnose remotely using a traditional web-browser running on a desktop PC or Apple Mac. The Dexis Webview Software is a software program for general dental and maxillofacial diagnostic imaging. It provides the ability to view, enhance, annotate, compare, and export images by accessing an existing image database available in a distributed environment. It allows remote access to x-ray digital images acquired from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flatbed scanner, or color images from intraoral dental cameras as long as they are stored in an accessible database.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K140445

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a web-based image viewing and processing software with no mention of AI or ML capabilities. The focus is on remote access and basic image manipulation tools.

Therapeutic

No.
The device is described as software for diagnostic image review, enhancing, annotating, comparing, and exporting images, which are diagnostic functions, not therapeutic.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that Dexis Webview is "used for general dental and maxillofacial diagnostic image review." Additionally, the "Device Description" mentions, "The intended use of the device is to allow dentists to be able to diagnose remotely."

SaMD (Software as a Medical Device)

Yes

The device is described as a "web-based software" and a "web browser-based accessory software application" that accesses pre-existing image data. There is no mention of any hardware components being part of the device itself, only the software's function of accessing data and providing viewing/processing tools.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).

Here's why:

Definition of IVD: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The tests are performed outside of the body ("in vitro").
Dexis Webview's Function: Dexis Webview is a software application that processes and displays medical images (dental and maxillofacial X-rays, camera images, etc.) for diagnostic review. It does not perform tests on biological samples.
Intended Use: The intended use is for "general dental and maxillofacial diagnostic image review" and allows users to "view, enhance, annotate, compare, and export images." This is clearly related to interpreting visual data, not analyzing biological samples.
Input Modality: The input modalities are imaging modalities (X-rays, cameras, scanned films), not biological samples.

While the device is used for diagnostic purposes (interpreting images to aid in diagnosis), it does so by processing and presenting visual information, not by performing tests on biological specimens. Therefore, it falls under the category of a medical imaging device or accessory software, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Dexis Webview is indicated for use only by prescription and by a trained and qualified dentist or dental technician.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

Device Description

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Dental X-rays, intraoral and extraoral images, images from imaging plates with the Photo-Stimulable Phosphor (PSP) scanners, images from intra-oral and extra-oral sensors, color images from intra-oral and extra-oral cameras, digital images (such as those obtained by scanning a film).

Anatomical Site

Dental and maxillofacial

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained and qualified dentist or dental technician / Distributed environment, remotely using a web-browser over a networked environment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The safety and effectiveness of the Dexis Webview web-browser software was evaluated via bench testing. verification and validation testing, and conformance to international conformance standards. The Dexis Webview Software performs equivalently in functionality as the cleared Dexis Software (K140445) with regards to viewing, enhancing, annotating, comparing, and exporting images by remotely accessing an existing image database available in a distributed environment. Dexis Webview complies with the following relevant standard: ISO 14971 Second edition 2007-03-01. medical devices - application of risk management to medical devices. Performance data (Verification and Validation) demonstrate that Dexis Webview web-browser software functions equivalently to the Dexis Software predicate device.

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.

K140445

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).

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).

Summary

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 7, 2015

Imaging Sciences International / Gendex / Dexis % Sanjay Ahuja, Ph.D. Director of Regulatory Affairs 1910 North Penn Road HATFIELD PA 19440

Re: K151941

Trade/Device Name: Dexis Webview Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 28, 2015 Received: September 18, 2015

Dear Dr. Ahuja:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ochs

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K151941

Device Name Dexis Webview

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

Dexis Webview

Submitter's Name, Address, Telephone Number

Dental Imaging Technologies Corporation (dba Imaging Sciences International LLC, dba Gendex LLC, Dexis LLC) 1910 North Penn Rd. Hatfield, PA 19440

Contact Person

Sanjay Ahuja, Ph.D. Email: sanjay.ahuja@kavokerrgroup.com Telephone: (267) 954-1463 Fax: (215) 997-5665.

Date Prepared

13 July 2015

Name of Device Dexis Webview

Name/Address of Sponsor

Dental Imaging Technologies Corporation (dba Imaging Sciences International LLC, dba Gendex LLC, Dexis LLC) 1910 North Penn Rd. Hatfield, PA 19440

Common or Usual Name

Dental Imaging Device

Product Code LLZ

Classification Name System, Image Processing, Radiology, per 21 CFR §892.2050.

Predicate Devices

Dexis Software (K140445)

Intended Use / Indications for Use

Dexis Webview is indicated for use only by prescription and by a trained and qualified dentist or dental technician.

Device Description

Technological Characteristics

The following are the technological characteristics between the Dexis Webview (K151941) and the cleared version of the Dexis Software (K140445):

Attribute	DEXIS Software (K140445)	Proposed Dexis Webview (K151941)
Type	Software only	Software only
Host Platform	PC & Apple Mac	PC & Apple Mac
Operating System	Microsoft Windows® XP Pro (32bit),
Microsoft Windows® Vista (32bit),
Microsoft Windows® 7 Pro (32bit or
64bit).
Note: Most supported devices do not
have 64bit drivers and thus need the
32bit version of Microsoft Windows 7
Apple Mac OS, minimum version
10.8	All compatible Web-browsers running under
the following Operating Systems:
Microsoft Windows® XP Pro (32bit),
Microsoft Windows® Vista (32bit).
Microsoft Windows® 7 Pro (32bit or 64bit).
Note: Most supported devices do not have
64bit drivers and thus need the 32bit version
of Microsoft Windows 7
Apple Mac OS, minimum version 10.8
Host RAM	Windows: Workstations: 1GB or
higher; Servers: 1GB or higher
Mac: Workstations: 4GB or higher;
Servers: 4GB or higher	n/a
Host magnetic storage	Windows: Workstations: 80GB or
larger: Servers: 120 GB or larger
Mac: Varies for different Apple Mac
OS devices, 1GB minimum of
available disk space for installation	n/a
CD ROM	No.
DVD or USB or Network Download
(for Installation)	No.
DVD or USB or Network Download (for
Installation)
Host Processor Speed	Windows: Intel® Pentium® 4 or
higher
Mac: None specified	Windows: Intel® Pentium® 4 or higher
Mac: None specified
Host Monitor Size	Windows: SVGA, XGA
recommended
Mac: None specified.	Windows: SVGA, XGA recommended
Mac: None specified.
Display resolution	Windows: 800 x 600 with a minimum
of .25 dot pitch
Mac: 1280 x 768 pixels minimum	Windows: 800 x 600 with a minimum of .25
dot pitch
Mac: 1280 x 768 pixels minimum

Attribute	DEXIS Software (K140445)	Proposed Dexis Webview (K151941)
Receive Images from
other systems	Yes	Yes
Images Displayed	Dental X-rays, intraoral and extraoral
Images	Dental X-rays, intraoral and extraoral
Images
Programming Code	Windows: 32-bit and 64-bit code
Mac: 64-bit code.	Windows: 32-bit and 64-bit code
Mac: 64-bit code.

The Dexis Webview software uses common web browsers (Internet Explorer, Chrome, etc) with regards to viewing, enhancing, annotating, comparing, and exporting images using the Dexis Core database in an alternate fashion similar to the access provided by the Dexis software and aiding in the practitioner's decision making process. The following is the functionality comparison:

Functionality	Dexis (K140445)	Proposed Dexis Webview (K151941)
Overall Functionality	The main imaging program for X-rays
and color images.	A remote viewer application for X-rays
and color images.
Overall Functionality	Includes functions to acquire images
from various sources, enhancement,
annotation, measurement, import/export
and printing.
Provides image acquisition workflows,
dental image display, and radiograph
enhancements.	Includes functions to analyze acquired
images from various sources,
enhancement, annotation, measurement,
import/export and printing.
While it does not provide image
acquisition workflows, it does provide
dental image display, and radiograph
enhancements.
Database	Images and metadata are stored in the
Dexis database.	Images and metadata are stored in the
Dexis Core database.
Driver Support	Acquires and displays dental images
from other imaging sensors.	Analyzes and displays dental images from
other imaging sensors which are stored in
the Dexis core database.
Accessibility	Can be accessed over a distributed
network	Can be accessed over a distributed
network

The Dexis Webview Software is a software program for general dental and maxillofacial diagnostic imaging. It provides the ability to view, enhance, annotate, compare, and export images by accessing an existing image database available in a distributed environment. It allows remote access to x-ray digital images acquired from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flatbed scanner, or color images from intraoral dental cameras as long as they are stored in an accessible database.

Dexis Webview allows the following functionality remotely using a standard web-browser:

. Access and analyze x-ray images acquired from imaging plates with the Photo-Stimulable Phosphor (PSP) scanners.
. Access and analyze x-ray images acquired using from intra-oral and extra-oral sensors.
. Access patient files remotely via a standard web-browser with established network connectivity.
. Access and view color images from intra-oral and extra-oral cameras,
. Access, export, and import digital images (such as those obtained by scanning a film) in several standard file formats.
. Process images with dental specific tools, to enhance their diagnostic value.
Analyze and enhance images in order to gather additional diagnostic information which may not be immediately apparent on initial visual inspection.
. Print images and image-related information over the network.

Dexis Webview is typically utilized remotely using a web-browser over a networked environment.

Substantial Equivalence

The Dexis Webview web-browser Software with the updated Indications for Use and intended use described in this submission is substantially equivalent to the Dexis Software cleared under K140445. It also satisfies all criteria of substantial equivalence based upon the above comparisons in the sections and does not raise new concerns in safety and effectiveness: (1) Indications for Use, (2) Technological Characteristics, and (3) Theory of Operations. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is safe and effective. Thus, the Dexis Webview (proposed under K151941) is substantially equivalent to the cleared Dexis Software (K140445).

Performance Data

Whereas Dexis Software can capture digital images from various sensors (e.g. intraoral), Dexis Webview can only view, enhance, annotate, compare, and export already acquired images by remotely accessing such images over the network. The proposed device has the same fundamental scientific technology, has not been reclassified, and has an intended use which correlates with that of the predicate device. The safety and effectiveness of the Dexis Webview web-browser software was evaluated via bench testing. verification and validation testing, and conformance to international conformance standards. The Dexis Webview Software performs equivalently in functionality as the cleared Dexis Software (K140445) with regards to viewing, enhancing, annotating, comparing, and exporting images by remotely accessing an existing image database available in a distributed environment. Dexis Webview complies with the following relevant standard: ISO 14971 Second edition 2007-03-01. medical devices - application of risk management to medical devices. Performance data (Verification and Validation) demonstrate that Dexis Webview web-browser software functions equivalently to the Dexis Software predicate device.