DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC

K140445 · Imaging Sciences International, LLC · LLZ · Apr 23, 2014 · Radiology

Device Facts

• Record ID: K140445
• Device Name: DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC
• Applicant: Imaging Sciences International, LLC
• Product Code: LLZ · Radiology
• Decision Date: Apr 23, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.

Device Story

DEXIS Software is a dental imaging management system used by dental professionals in clinical settings. It functions as a Picture Archiving and Communication System (PACS) for dental and maxillofacial applications. The device interfaces with digital X-ray sensors, flatbed scanners, and intra-oral/extra-oral cameras to acquire image data. It provides tools for the display, enhancement, and storage of these images. By centralizing image management, the software assists clinicians in diagnostic workflows, allowing for efficient review and documentation of patient dental anatomy. The output is presented on a computer monitor for clinical decision-making regarding dental treatment planning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based PACS for dental/maxillofacial imaging. Functions include image capture, display, enhancement, and storage. Compatible with digital X-ray systems, flatbed scanners, and intra-oral/extra-oral cameras. Operates as a standalone software application on standard computing hardware.

Indications for Use

Indicated for general dental and maxillofacial diagnostic imaging. Used by dental professionals to capture, display, enhance, and save digital X-ray images, digitized film, and intra-oral/extra-oral camera images.

Regulatory Classification

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).

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

April 23, 2014

Imaging Sciences International, LLC Sanjay Ahuja Regulatory Affairs Director 1910 North Penn Road HATFIELD PA 19440

Re: K140445

Trade/Device Name: DEXIS Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 26, 2014 Reccived: March 27, 2014

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 10 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 that I DT has made a avenulations administered by other Federal agencies. You must or any I cached statuted and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K F art 607), labeling (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic (200 form in the quality by cronics (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Dr. Ahuja

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/dcfault.htm1 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Smh 73)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510{k) Number (if known) K140445

Device Name DEXIS Software

#### Indications for Use (Describe)

The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.

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)

# PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.