Cliniview software program is indicated for general dental and maxillofacial diagnostic imaging. It controls capture, 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

Cliniview software has the functionality which compares with the functionality provided by VixWin Platinum predicate cleared under K141451, the DEXIS Software predicate cleared under K140445 and the Romexis predicate cleared under K140713.

Scanora software is equal with the Cliniview software with branding labeling differences. Scanora is product name for Soredex brand imaging products whereas Cliniview is for Instrumentarium Dental imaging products. There is no difference in design. Cliniview 11 equals Scanora 6. This submission discusses about Cliniview software covering Scanora software at the same time.

The types of images handled by Cliniview include, for example, panoramic, cephalometric, CBCT, intra-oral, and color photographs, Images can be viewed from a workstation, a mobile application or using a web browser. The Mobile Application is not intended for diagnostic use.

Cliniview image acquisition supports imaging plates, intraoral sensors and digital X-ray imaging devices. Images can also be imported from other digital sources. Cliniview stores images and patient information in the SQL database and provides tools for image archiving. Cliniview has interfaces to 3rd party systems through the proprietary dental practice management system interface and DICOM standard interface.

The main features of the Cliniview software include patient management, image acquisition, patient and image data storage, image viewing of 2D images and processing and enhancement of images.

Cliniview software can be utilized either locally or over a networked environment. If Cliniview is installed on several computers, the patient and image database can be shared among them and used from different workstations.

AI/ML Overview

The provided text is a 510(k) summary for the Cliniview software, which is a Picture Archiving and Communications System (PACS) for dental and maxillofacial diagnostic imaging. It describes the device's intended use, technological characteristics, and its comparison to predicate devices, but it does not contain any information about acceptance criteria, specific performance data (e.g., accuracy, sensitivity, specificity), sample sizes for test or training sets, expert qualifications, or adjudication methods.

Therefore, I cannot extract the requested information as it is not present in the provided document.

To fulfill your request, the document would need to include details of a clinical study or performance evaluation with quantifiable metrics for the Cliniview software's performance, alongside predefined acceptance criteria.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other.

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

April 25, 2017

Palodex Group Oy Jouni Karkinen Regulatory Manager Nahkelantie 160 FI-04300 Tuusula, FINLAND

Re: K162799 Trade/Device Name: Cliniview Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: March 14, 2017 Received: March 20, 2017

Dear Jouni Karkinen:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/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,

Michael D.'Hara

For

Robert A. Ochs, Ph.D. 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

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

510(k) Number (if known) K162799

Device Name Cliniview

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) SUMMARY

Cliniview

Submitter Information

Palodex Group Oy Nahkelantie 160 FI-04300 Tuusula Finland

Contact Person:	Jouni Karkinen
Email:	regulatory@palodex.com
Telephone Number:	+358 10 270 2000
Fax Number:	+358 10 270 2230

Date Prepared:

March 14, 2017

Device Name

Proprietary Name:	Cliniview
Common name:	Dental imaging
Classification Name:	System, Imaging
CFR Number:	892.2050
Device Class:	2
Product Code:	LLZ

ng device ge Processing, Radiological

Predicate Device

Proprietary Name:	VixWin Platinum
510k Number:	K141451
Common Name:	Dental imaging device
Classification Name:	System, Image Processing, Radiological
CFR Number:	892.2050
Device Class:	2
Product Code:	LLZ

Predicate Device

Proprietary Name: 510k Number: Common Name:

DEXIS Software K140445 Dental imaging device

PaloDEx Group Oy

Street address Nahkelantie 160 04300 Tuusula Finland

Finland

Postal address Phone P.O. Box 64 FI-04301 Tuusula

VAT +358 10 270 2000

Fl19774137

BI code 1977413-7 Bank Nordea Bank SWIFT NDEAFIHH Account
Fl9015963000046864

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Classification Name:	System, Image Processing, Radiological
CFR Number:	892.2050
Device Class:	2
Product Code:	LLZ

Predicate Device

Proprietary Name:	Romexis
510k Number:	K140713
Common Name:	Dental imaging device
Classification Name:	System, Image Processing, Radiological
CFR Number:	892.2050
Device Class:	2
Product Code:	LLZ

Description of Device

The main features of the Cliniview software include patient management, image acquisition, patient and image data storage, image viewing of 2D images and processing and enhancement of images.

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Image /page/5/Picture/0 description: The image shows the words "Palodex Group" in black font. The word "Palodex" is on the top line and is in a larger font than the word "Group" which is on the second line. The word "Group" is slightly offset to the right compared to the word "Palodex".

Shelf-life is not applicable to Cliniview software, because of no likelihood of time-dependent product degradation. Performance data is not needed to establish maintenance of device performance characteristics over the shelf-life period.

Indications for Use

Technological Characteristics

The following table 7-1 gives technological characteristics between the proposed Cliniview software and the cleared version of the VixWin Platinum Software (K141451), the DEXIS Software (K140445) and the Romexis (K140713).

Feature	VixWin Platinum(K141451)(Predicate)	DEXIS Software(K140445)(Predicate)	Romexis(K140713)(Predicate)	Cliniview(Proposed)
Indication forUse / IntendedUse	VixWin Platinumis a softwareprogram forgeneral dentaland maxillofacialdiagnosticimaging.It controlscapture, display,enhancement,and saving ofdigital imagesfrom variousdigital imagingsystems. It storesandcommunicatesthese imageswithin the systemor acrosscomputersystems atdistributedlocations.	The DEXISSoftware is asoftware programfor general dentaland maxillofacialdiagnostic imaging.It controls capture,display,enhancement andsaving of X-raydigital images fromdigital imagingsystems. It canalso handle othertypes of imagesacquired bydigitizing film with aflatbed scanner, orcolor imagesfrom intra-oral andextra-oral dentalcameras.	PlanmecaRomexis is amedical imagingsoftware, and isintended for usein dental andmedical care as atool for displayingand visualizingdental andmedical 2D and3D image filesfrom imagingdevices, such asprojectionradiography andCBCT. It isintended toretrieve, process,render, diagnose,review, store,print, anddistribute images.	Cliniview softwareprogram isindicated forgeneral dental andmaxillofacialdiagnostic imaging.It controls capture,display,enhancement, andsaving of digitalimages fromvarious digitalimaging systems. Itstores andcommunicatesthese imageswithin the systemor across computersystems atdistributedlocations.
Implementation	Software only	Software only	Software only	Software only
Feature	VixWin Platinum(K141451)(Predicate)	DEXIS Software(K140445)(Predicate)	Romexis(K140713)(Predicate)	Cliniview(Proposed)
OverallFunctionality	The imagingprogram for X-rayand color images	The imagingprogram for X-rayand color images	The imagingsoftware fordigital imagingdevices and videocameras	The imagingprogram for X-rayand color images
ImageProcessingFunctionality	Enhancement.annotation,measurement,import/export andprinting.	Enhancement,annotation,measurement,import/export andprinting.	Enhancementand archivingimages.	Enhancement,annotation,measurement,import/export andprinting.
Host Platform	PC	PC & Apple Mac	PC & Apple Mac	PC
Host OperatingSystem	Windows 7Professional(32/64-bit)Windows 8Professional(32/64-bit)Windows XPProfessional(32/64-bit)Windows VistaBusiness (32/64-bit)Windows Server2003Windows Server2008	Windows XPProfessional SP3(32 bit)Windows VistaBusiness SP2 (32bit)Windows 7Professional,Ultimate,Enterprise, all SP1(32 and 64 bit)Windows Server2003Windows Server2008	Windows 7 Pro(32 or 64 bit)Windows 8.1 Pro(32 or 64 bit)Windows 10 (64bit)Windows 2008Server (64 bit)Windows 2012Server (64 bit)Mac OS X (Intel)	Windows 7Professional/Ultimate/Enterprise SP1 (32or 64-bit)Windows 8/8.1Professional/Enterprise (32 or64-bit)Windows 10Windows Server2012/2012R2
Host RAM	1024 MBminimum, 2048MBrecommended	Workstations: 1 GBor higherServers: 1 GB orhigher	Workstations: 3/ 8GBServers: 3/ 8 GB	4 GB
Host magneticstorage	30 GB minimum,200 GBrecommended	Workstations: 80GB or largerServers: 120 GB orlarger	Workstation: 80GBServers: 2 x 500GB	8 GB free space10 GB hard diskdatabase
Host floppydrives	Not required	Not required	Not required	Not required
InstallationMedia	DVD or Network	CD/DVD, USB andnetwork download	DVD ROM orR/W drive	DVD or Network
Feature	VixWin Platinum(K141451)(Predicate)	DEXIS Software(K140445)(Predicate)	Romexis(K140713)(Predicate)	Cliniview(Proposed)
Host ProcessorSpeed	Pentium 4 2.0GHz min,Pentium 4 3.2GHzrecommended	Windows: Intel®Pentium® 4 orhigher	Processor IntelCore 2 Duo 2GHz or better	Intel Core i3 orbetter
Host MonitorSize	SVGA with0.25/0.26 dotpitch	Windows: SVGA,XGArecommended	Full HD	19" or largerrecommended
Displayresolution	1024 x 768 24 bittrue color min, 32bit true colorrecommended	Windows: 800 x600 with aminimum of .25dot pitchMac: 1280 x 768pixels minimum	1280 x 1024(1920x1080recommended)	1280 x 1024resolution24-bit colorMonitor mustprovide abrightness of300cd/m2 forrooms < 1000 luxMonitor mustprovide a minimumcontrast ratio of100:1
User DisplayPreferences	Yes	Yes	Yes	Yes
USB and SVideo support	USB and S Videosupport	USB and S Videosupport	USB support	USB and S Videosupport
ReceiveImages fromother Systems	Yes	Yes	Yes	Yes
ImagesDisplayed	2D dental X-rays, intraoraland extraoralimages	2D dental X-rays,intraoral andextraoral Images	2D and 3Ddental X-rays,intraoral andextraoral images	2D dental X-rays,intraoral andextraoral images
Database	Images andrelated data arestored in theVixWin Platinumdatabase orremotelyaccessibledatabase in thenetwork.	Images andmetadata arestored in theDEXIS database.	Images andmetadata arestored in theRomexisdatabase.	Images andrelated data arestored in theCliniviewdatabase orremotelyaccessibledatabase in thenetwork.
ImageAcquisition	Imaging platescanners,intraoralsensors,intra oral videocamera,	Digitizing film witha flatbed scanner,or color imagesfrom intra-oral andextra-oral dentalcameras	Imaging platescanners,intraoralsensors,intra oral videocamera,	Imaging platescanners,intraoral sensors,intra oral videocamera,
Feature	VixWin Platinum(K141451)(Predicate)	DEXIS Software(K140445)(Predicate)	Romexis(K140713)(Predicate)	Cliniview(Proposed)
	digital extra oralx-ray devices,various imagefile formats	digital extra oralx-ray devices,various imagefile formats	digital extra oralx-ray devices,various imagefile formats	digital extra oral x-ray devices,various image fileformats
Viewers /Modes	Panoramic,Cephalometric,CBCT, Intra-oral,colorphotographs	Panoramic,Cephalometric,CBCT, Intra-oral,color photographs	IntraoralPanoramicCephalometric2D lineartomographyPhotosStack images3D CBCT3D photo3D surface scan	Panoramic,Cephalometric,CBCT, Intra-oral,color photographs
ImplantPlanning	Not included	Implant library,which can beused for implantplanningsearching forimplants.	Optional implantlibrary, whichcan be used forimplant planning,searching forimplants,creating newimplants,modifying,adding andreplacingimplants in theplan.	Implant library,which can be usedfor implantplanning,searching forimplants, creatingnew implants,modifying, addingand replacingimplants in theplan.
SupportsMobileApplication	No	No	iPad and iPhoneapplication	iPad application

Table 7-1

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Image /page/8/Picture/0 description: The image shows the logo for Palodex Group. The word "Palodex" is written in a large, bold, sans-serif font. Below and to the right of "Palodex" is the word "Group" in a smaller, sans-serif font. The text is black and the background is white.

Non clinical performance data

The safety and effectiveness of Cliniview software including Mobile app has been evaluated via internal in-house design verification and validation testing and via conformance to international standards.

As part of verification and validation conformance IEC 62304 and ISO 14971, design validation, unit testing, code reviews, integration testing and system verification testing was ensured for Cliniview.

Substantial Equivalence

There are no significant differences between the proposed Cliniview software and the predicate VixWin Platinum, DEXIS Software and Romexis devices. Minor differences, as described in Table 7-1, between proposed the Cliniview software and the predicate devices do not significantly affect substantial equivalence of the device.

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The proposed device is substantially equivalent to the predicate devices based on the indications for use, technological characteristics and theory of operations. Minor differences between proposed Cliniview software and the predicate devices relating to required hardware, and operating system functionality do not significantly affect safety and effectiveness. In summary, Cliniview software described in this submission is substantially equivalent to the Vixwin Platinum software cleared under K141451, the DEXIS Software cleared under K140445 and the Romexis cleared under K140713 and satisfies all criteria of substantial equivalence.

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).