K Number
K192165
Device Name
Acteon Imaging Suite
Manufacturer
Date Cleared
2020-02-11

(186 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Acteon Imaging Suite software program is indicated for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.
Device Description
AIS-Acteon Imaging Suite is an application software suite providing a set of tools used to meet the imaging requirements set by different types of dental facilities – from small clinics to large hospitals. It enables practitioners to process and permanently archive (in connection with patients) diagnostic images relating to intraoral, maxillofacial and ear nose throat areas. Images can be originated by: intraoral digital sensors, dental panoramic and cephalometric equipment, CBCT equipment, intraoral cameras and all the future ACTEON digital imaging devices. The devices that are intended to be used with AIS are X-MIND trium, X-MIND PRIME and Cameras, Sopix², Sopix2 ACE, PSPix, PSPix2, SOPROCare camera and SOPROLife (with SDK provided by ACTEON-SOPRO). AIS supports DICOM format, which makes the system flexible and ready to be connected to other compatible devices and applications.
More Information

No reference devices were used in this submission.

No
The summary describes standard image processing and archiving software for dental imaging, with no mention of AI or ML capabilities. The performance studies focus on image quality and clinical suitability compared to predicates, not on algorithmic performance metrics typically associated with AI/ML.

No.
The device is described as an "Imaging Suite software program" and "application software suite" indicated for "general dental and maxillofacial diagnostic imaging." Its functions are related to controlling exam retrieval, display, enhancement, saving, storing, and communicating digital images, which are all diagnostic functions, not therapeutic.

Yes
The "Intended Use / Indications for Use" section explicitly states that the software program is "indicated for general dental and maxillofacial diagnostic imaging." This directly indicates its diagnostic purpose. Additionally, the "Device Description" mentions that it enables practitioners to "process and permanently archive... diagnostic images."

Yes

The device is described as an "application software suite" and its function is to control, process, store, and communicate digital images from various digital imaging systems. While it interacts with hardware (imaging devices), the device itself is the software program.

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

Here's why:

  • IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that this software processes and displays images from various dental and maxillofacial imaging systems (sensors, panoramic, CBCT, cameras). These are images of the patient's anatomy, not specimens taken from the patient.
  • The purpose is diagnostic imaging of anatomical structures. The software is used for "general dental and maxillofacial diagnostic imaging" and to "process and permanently archive... diagnostic images relating to intraoral, maxillofacial and ear nose throat areas." This is consistent with medical imaging, not in vitro diagnostics.

Therefore, the Acteon Imaging Suite software program, as described, falls under the category of medical imaging software, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

Acteon Imaging Suite software program is indicated for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

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

LLZ

Device Description

AIS-Acteon Imaging Suite is an application software suite providing a set of tools used to meet the imaging requirements set by different types of dental facilities – from small clinics to large hospitals. It enables practitioners to process and permanently archive (in connection with patients) diagnostic images relating to intraoral, maxillofacial and ear nose throat areas. Images can be originated by: intraoral digital sensors, dental panoramic and cephalometric equipment, CBCT equipment, intraoral cameras and all the future ACTEON digital imaging devices. The devices that are intended to be used with AIS are X-MIND trium, X-MIND PRIME and Cameras, Sopix², Sopix2 ACE, PSPix, PSPix2, SOPROCare camera and SOPROLife (with SDK provided by ACTEON-SOPRO). AIS supports DICOM format, which makes the system flexible and ready to be connected to other compatible devices and applications.

AIS GUI consists of the following main parts:

  • Patient selection window
  • Clinic view
  • 2D App
  • 3D App
  • AIS Report Module
  • AIS Configurator

Acteon Imaging Suite has the possibility to be deployed in a Local Area Network (LAN) in a Client-Server architecture:

  • Clients are dedicated to exam retrieval, display and enhancement;
  • Server is dedicated to store patient data and images, it provides also all the functionalities available on the client.

Communication between server and client is made in TCP/IP.
Exam data are stored on server Hard Drive Disk (HDD) or Solid Stated Drive (SSD) in anonymized image files. Patient data are stored in crypted database to ensure privacy, the database file data are usually installed in the same drive of the exam data. Acteon Imaging Suite provides the user with facilities for backup the data to prevent disk failure.

Exam are saved both in Acteon proprietary format (DGI) as RAW or in standard format (TIF, JPG, PNG or DICOM). The proprietary format (DGI) is used to give the user the possibility to apply different filters.

Acteon Imaging Suite can be installed on every hardware compliant with the minimum requirements. No hardware is provided with the software. Hardware, with Acteon Imaging Suite installed, can be provided by de Götzen S.r.l. – ACTEON Group with other Acteon Devices, for example X-MIND trium.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

intraoral digital sensors, dental panoramic and cephalometric equipment, CBCT equipment, intraoral cameras and all the future ACTEON digital imaging devices.

Anatomical Site

general dental and maxillofacial, ear, nose, throat areas

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental facilities – from small clinics to large hospitals.

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)

Software is verified through unit, integration, system and architecture testing. Since the functionalities of AIS are the same of the predicate device ones and, since there are no significant technology differences, the equivalence has been demonstrated comparing the image rendering of different software with regards to the clinical effectiveness of that image.

Three independent reviewers having different backgrounds (maxillofacial surgery, orthodontics, dentistry) evaluated the same images, rendered on the same hardware (both Windows and MacOs) or printed with same printer, in order to evaluate the image quality (anatomical coverage, density and image contrast and anatomical structures) to assess suitability for clinical use.

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.

K162799, K171385

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.

No reference devices were used in this submission.

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

§ 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).

0

February 11, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an eagle emblem, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font size and a blue square behind it.

de Götzen S.r.l % Dario Bandiera Quality Manager via Roma, 45 Olgiate, Olona 21057 ITALY

Re: K192165

Trade/Device Name: Acteon Imaging Suite Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 2, 2019 Received: January 13, 2020

Dear Dario Bandiera:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K192165

Device Name Acteon Imaging Suite

Indications for Use (Describe)

Acteon Imaging Suite software program is indicated for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

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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Image /page/3/Picture/0 description: The image shows the logo for ACTEON above an address. The address is "Via Roma, 45, 21057 Olgiate Olona (VA)". The ACTEON logo is in dark gray with a light blue swoosh above it.

510 (k) submission Section 3

Of February Rev. 4th2019 4.0

Index

SUBMITTER
DEVICE
PRIMARY PREDICATE DEVICE
SECONDARY PREDICATE DEVICE…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
DEVICE DESCRIPTION
Network functionalities
I.
Data Storaqe
II.
Exam format
III.
Hardware
IV.
INDICATIONS FOR USE
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Non clinical performance data:
INTERNAL DESIGN VERIFICATION AND VALIDATION TESTING
CONFORMANCE TO RECOGNIZED STANDARDS AND GUIDELINES
SUMMARY FOR ANY PERFORMANCE TESTING IN THE SUBMISSION
CONCLUSIONS

4

Image /page/4/Picture/0 description: The image shows the logo for ACTEON, with the company name in bold, dark gray letters and a light blue curved line above the name. Below the logo is the address "Via Roma, 45, 21057 Olgiate Olona (VA)" in a simple, sans-serif font. The address is left-aligned and provides the location of the company.

The summary of this 510(k) is submitted in accordance with the requirements of 21 CFR Part 807.92.

SUBMITTER

Owner's name:de Götzen S.r.l. – ACTEON Group
Address:via Roma, 45 – 21057 Olgiate Olona (VA), Italy
Tel.+39 0331 376760
Fax+39 0331 376763
Contact Person:Dario Bandiera – dario.bandiera@acteongroup.com
Date:September 24th,2019

Table 1: Submitter

DEVICE

Name of the device:Acteon Imaging Suite
Common or Usual
name:Imaging application software
Classification name:Picture Archiving and Communication System
(21 CFR 892.2050)
Regulatory class:II
Product Code:LLZ

Table 2: device

PRIMARY PREDICATE DEVICE

Legally marketed device to which equivalence is claimed is:

PRIMARY PREDICATE DEVICE
Device nameCliniview
ManufacturerPalodex Group Oy
Device product codeLLZ
Regulation number21 CFR 892.2050
Regulation namePicture Archiving and Communication System
Clearance dateApril, 25 2017
510(k) numberK162799

Table 3: primary predicate device

This predicate has not been subjected to a design-related recall.

Acteon Imaging Suite 510 (k) Summary

5

Image /page/5/Picture/0 description: The image shows the logo for ACTEON, with the company name in bold, dark gray letters and a light blue swoosh above the name. Below the logo is the address "Via Roma, 45, 21057 Olgiate Olona (VA)". The address is in a simple, sans-serif font.

510 (k) submission Section 3

Rev. Of February 4th2019 4.0

SECONDARY PREDICATE DEVICE

Legally marketed device to which equivalence is claimed is:

SECONDARY PREDICATE DEVICE
Device namePlanmeca Romexis
ManufacturerPlanmeca Oy
Device product codeLLZ
Regulation number21 CFR 892.2050
Regulation namePicture Archiving and Communication System
Clearance dateNovember, 14 2017
510(k) numberK171385

Table 4: secondary predicate device

This predicate has not been subjected to a design-related recall.

No reference devices were used in this submission.

DEVICE DESCRIPTION

AIS-Acteon Imaging Suite is an application software suite providing a set of tools used to meet the imaging requirements set by different types of dental facilities – from small clinics to large hospitals. It enables practitioners to process and permanently archive (in connection with patients) diagnostic images relating to intraoral, maxillofacial and ear nose throat areas. Images can be originated by: intraoral digital sensors, dental panoramic and cephalometric equipment, CBCT equipment, intraoral cameras and all the future ACTEON digital imaging devices. The devices that are intended to be used with AIS are X-MIND trium, X-MIND PRIME and Cameras, Sopix², Sopix2 ACE, PSPix, PSPix2, SOPROCare camera and SOPROLife (with SDK provided by ACTEON-SOPRO). AIS supports DICOM format, which makes the system flexible and ready to be connected to other compatible devices and applications.

Here below a scheme showing the main components of the device under analysis:

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Image /page/6/Figure/0 description: This image shows a diagram of the Acteon Imaging Suite. The diagram starts with the imaging device at the top, followed by the communication module. The communication module connects to the AIS GUI, which then connects to the data management, 2D viewer, and 3D viewer.

Figure 1: main components

The acquisition device communicates and transfer data to AIS through dedicated communication modules. These modules are specifically designed or rely completely on well-known and established Twain communication protocol.

AIS GUI consists of the following main parts:

  • Patient selection window .
    Image /page/6/Picture/5 description: The image shows a patient data screen with a search patient function. The left side of the screen has a filter by section with a search bar. Below the search bar is a table with patient data including last name, first name, external ID, and DICOM ID. The right side of the screen shows patient information for Enrico Rossi, including a picture, date of birth (28/09/1901), address (Via Garibaldi 1), and a reference number.

Figure 2: Patient selection window

Patient selection window allows the user to search the patient folder and open related clinic view that contains all diagnostic acquired or imported images, report and so on.

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Image /page/7/Picture/0 description: The image contains the logo for ACTEON, which is in bold, dark gray font. Below the logo is the address "Via Roma, 45, 21057 Olgiate Olona (VA)". The address is in a smaller, black font.

510 (k) submission Section 3 Of February Rev.

4th2019 4.0

  • . Clinic view
    Image /page/7/Picture/5 description: The image shows a screenshot of a dental imaging software interface. On the left side, there is a panel with patient information and dental chart. The right side displays a panoramic X-ray image of a patient's teeth. The software interface includes various tools and options for dental imaging and analysis.

Figure 3: Clinic view

Clinic view allows to show all diagnostic images acquired or imported, report It is possible to filter the exam by date, exam type or by dental chart. Clinic view is the starting point to perform a new exam. It's also possible to open 3D viewer tool for 3D datasets or 2D viewer tool for 2D acquisitions.

2D App .

Image /page/7/Picture/9 description: The image shows a dental X-ray displayed on a computer screen. The X-ray reveals a full set of teeth, including molars, premolars, canines, and incisors, in both the upper and lower jaws. The image is captured using dental imaging software, as indicated by the application's interface visible on the screen.

Figure 4: 2D App

2D App is the tool to view 2D images. In that tool it is possible to adjust image, gamma, contrast, luminosity and sharpness. 2D App provides also tools to annotate the image.

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Image /page/8/Picture/0 description: The image shows the Acteon logo above the address "Via Roma, 45 21057 Olgiate Olona (VA)". The Acteon logo is a stylized text with a blue swoosh above it. The address is written in a simple, sans-serif font.

510 (k) submission Section 3 Rev. Of February

4th2019 4.0

  • 3D App .
    Image /page/8/Picture/5 description: The image shows a 3D rendering of a human jaw with teeth, along with a software interface for dental implant planning. The interface includes tools for implant placement, abutment design, and bone segmentation. The 3D rendering provides a detailed view of the jaw structure, while the software interface allows for precise planning of dental implant procedures.

Figure 5: 3D APP

3D App is the tool to view 3D volumes and plan implants. It is cleared under K173041 3DIEMME Ltd.

  • AIS Report Module .
    Image /page/8/Picture/9 description: The image shows a dental x-ray report. The report includes patient information such as the patient's name, "DefaultLastName DefaultFirstName", and date of birth, "1/1/00". The report also includes the acquisition date of the x-ray, which is "6/26/15", and the report was edited on "5/20/19" by Dr. Clinical Case 1.

Figure 6: AIS report module

Report module provides the functionalities to allow the user to create customized reports, generating Portable Data Format (PDF) documents or printing directly on standard printers.

9

Image: ACTEON logo
Via Roma, 45
21057 Olgiate Olona (VA)

510 (k) submission Section 3 Rev. Of February 4.0 4th2019

  • AIS Configurator .
    Image /page/9/Picture/4 description: The image shows a screenshot of the "AIS Configurator" software. The software's interface includes a menu bar with options like "File," "Administration," "Dicom," "Tools," "Configuration," and "License." Below the menu bar, there is a toolbar with various icons. The main area of the window displays a cartoon image of a blue bird standing next to a gear.

Figure 7: AIS configurator

This application is needed to manage database, change AIS general settings and set up PMS communication.

The data management component is needed to store patient data and images into AIS database and to manage them.

2D and 3D viewer are the tools required for data representation, both implement also image processing and measuring features.

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Image /page/10/Picture/0 description: The image shows the Acteon logo above the address "Via Roma, 45 21057 Olgiate Olona (VA)". The Acteon logo is in black with a blue swoosh above it. The address is in black text and is located below the logo. The background of the image is white.

Network functionalities I.

Acteon Imaging Suite has the possibility to be deployed in a Local Area Network (LAN) in a Client-Server architecture:

  • Clients are dedicated to exam retrieval, display and enhancement; .
  • Server is dedicated to store patient data and images, it provides also all the . functionalities available on the client.

Image /page/10/Figure/8 description: This image shows a diagram of a client-server network for dental imaging. The client side includes a dental imaging machine, a computer with dental imaging software, and dental tools. The server side includes a server and a database. The diagram shows that the client and server are connected via a network.

Communication between server and client is made in TCP/IP.

II. Data Storage

Exam data are stored on server Hard Drive Disk (HDD) or Solid Stated Drive (SSD) in anonymized image files.

Patient data are stored in crypted database to ensure privacy, the database file data are usually installed in the same drive of the exam data.

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Image /page/11/Picture/0 description: The image shows the Acteon logo above the address "Via Roma, 45 21057 Olgiate Olona (VA)". The Acteon logo is in black with a blue swoosh above it. The address is in black text and is located below the logo. The background of the image is white.

510 (k) submission Section 3

Acteon Imaging Suite provides the user with facilities for backup the data to prevent disk failure.

Exam format III.

Exam are saved both in Acteon proprietary format (DGI) as RAW or in standard format (TIF, JPG, PNG or DICOM).

The proprietary format (DGI) is used to give the user the possibility to apply different filters,

Hardware IV.

Acteon Imaginq Suite can be installed on every hardware compliant with the minimum requirements. No hardware is provided with the software.

Hardware, with Acteon Imaging Suite installed, can be provided by de Götzen S.r.l. – ACTEON Group with other Acteon Devices, for example X-MIND trium.

INDICATIONS FOR USE

Acteon Imaging Suite software program is indicated for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The table here below contains a comparison of the technological characteristics

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Image /page/12/Picture/0 description: The image shows the logo for ACTEON. The logo features the company name in bold, dark gray letters. A blue curved line is above the company name. The text "Via Roma, 45" is below the logo.

510 (k) submission Section 3

Via Roma, 45 21057 Olgiate Olona (VA)

ProposedPredicate 1Predicate 2
FeatureActeon Imaging Suite
(AIS)CliniviewRomexis
Manufacturerde Götzen S.r.l. -
ACTEON GroupKaVoPlanmeca
510
(k)
numberTo be obtainedK162799K171385
Indication for
use / intended
useActeon Imaging
Suite software
program is
indicated for
general dental and
maxillofacial
diagnostic
imaging. It controls
exam retrieval,
display,
enhancement, and
saving of digital
images from
various digital
imaging systems. It
stores and
communicates
these images
within the system
or across computer
systems at
distributed
locations.Cliniview software
program is
indicated for
general dental and
maxillofacial
diagnostic
imaging. It controls
capture, display,
enhancement, and
saving of digital
images from digital
various imaging
systems. It stores
and communicates
these images
within the system
or across computer
systems at
distributed
locations.Planmeca
Romexis is a
medical
imaging
software, and is
intended for
use in dental
and medical
care as a tool
for displaying
and visualizing
dental and
medical 2D and
3D image files
from imaging
devices, such as
projection
radiography
and CBCT. It is
intended to
retrieve,
process,
render,
diagnose,
review, store,
print, and
distribute
images.
ProposedPredicate 1Predicate 2
FeatureActeon Imaging Suite
(AIS)CliniviewRomexis
ImplementationSoftware OnlySoftware OnlySoftware Only
Host
processor
speedIntel Core i5 or
betterIntel Core i3 or
betterProcessing Intel
Core 2 Duo 2
GHz or better
Host Monitor
sizeFull HD19" or larger
recommendedFull HD
Display
resolution1600x10241280x1024
resolution 24-bit
color Monitor must
provide a
brightness of
300cd/m2 for
rooms