Cliniview

K162799 · Palodex Group OY · LLZ · Apr 25, 2017 · Radiology

Device Facts

• Record ID: K162799
• Device Name: Cliniview
• Applicant: Palodex Group OY
• Product Code: LLZ · Radiology
• Decision Date: Apr 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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 Story

Cliniview is a dental/maxillofacial imaging software; manages capture, display, enhancement, and storage of digital images (panoramic, cephalometric, CBCT, intra-oral, color photos). Inputs include digital imaging systems (sensors, plates, cameras) and imported files; outputs are processed images for clinical review. Used in dental clinics; operated by dental professionals. Software runs on PC workstations; supports networked database sharing and mobile application access (non-diagnostic). Clinicians use output for diagnostic assessment and implant planning; facilitates patient care through centralized image management and communication across distributed systems.

Clinical Evidence

Bench testing only. Safety and effectiveness evaluated via internal design verification and validation, including unit testing, code reviews, integration testing, and system verification. Conformance to IEC 62304 (software lifecycle) and ISO 14971 (risk management) standards.

Technological Characteristics

Software-only dental imaging system. Operates on Windows-based PCs. Supports SQL database for image/patient data storage. Interfaces via DICOM and proprietary dental practice management protocols. Features include image acquisition (sensors, plates, cameras), 2D/3D viewing, enhancement, annotation, measurement, and implant planning tools. Connectivity via local or networked environment.

Indications for Use

Indicated for general dental and maxillofacial diagnostic imaging. Used for capturing, displaying, enhancing, saving, storing, and communicating digital images (panoramic, cephalometric, CBCT, intra-oral, color photographs) from various digital imaging systems. No specific patient population contraindications provided.

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).

Predicate Devices

• VixWin Platinum (K141451)
• DEXIS Software (K140445)
• Romexis (K140713)

Submission Summary (Full Text)

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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 [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" (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 [phone] or [phone] 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)

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.

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 [e-mail]

"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: | [e-mail] |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |

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 [phone]

Fl19774137

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

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Image /page/4/Picture/0 description: The image shows the words "Palodex Group" in black font. The word "Palodex" is on the top line and is larger than the word "Group", which is on the bottom line. The word "Group" is slightly offset to the right.

| 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

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.

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.

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.

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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

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.

#### 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<br>(K141451)<br>(Predicate) | DEXIS Software<br>(K140445)<br>(Predicate) | Romexis<br>(K140713)<br>(Predicate) | Cliniview<br>(Proposed) |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>Use / Intended<br>Use | VixWin Platinum<br>is a software<br>program for<br>general dental<br>and maxillofacial<br>diagnostic<br>imaging.<br><br>It controls<br>capture, display,<br>enhancement,<br>and saving of<br>digital images<br>from various<br>digital imaging<br>systems. It stores<br>and<br>communicates<br>these images<br>within the system<br>or across<br>computer<br>systems at<br>distributed<br>locations. | The DEXIS<br>Software is a<br>software program<br>for general dental<br>and maxillofacial<br>diagnostic imaging.<br><br>It controls capture,<br>display,<br>enhancement and<br>saving of X-ray<br>digital images from<br>digital imaging<br>systems. It can<br>also handle other<br>types of images<br>acquired by<br>digitizing film with a<br>flatbed scanner, or<br>color images<br>from intra-oral and<br>extra-oral dental<br>cameras. | Planmeca<br>Romexis is a<br>medical imaging<br>software, and is<br>intended for use<br>in dental and<br>medical care as a<br>tool for displaying<br>and visualizing<br>dental and<br>medical 2D and<br>3D image files<br>from imaging<br>devices, such as<br>projection<br>radiography and<br>CBCT. It is<br>intended to<br>retrieve, process,<br>render, diagnose,<br>review, store,<br>print, and<br>distribute images. | Cliniview software<br>program is<br>indicated for<br>general dental and<br>maxillofacial<br>diagnostic imaging.<br><br>It controls capture,<br>display,<br>enhancement, and<br>saving of digital<br>images from<br>various digital<br>imaging systems. It<br>stores and<br>communicates<br>these images<br>within the system<br>or across computer<br>systems at<br>distributed<br>locations. |
| Implementation | Software only | Software only | Software only | Software only |
| Feature | VixWin Platinum<br>(K141451)<br>(Predicate) | DEXIS Software<br>(K140445)<br>(Predicate) | Romexis<br>(K140713)<br>(Predicate) | Cliniview<br>(Proposed) |
| Overall<br>Functionality | The imaging<br>program for X-ray<br>and color images | The imaging<br>program for X-ray<br>and color images | The imaging<br>software for<br>digital imaging<br>devices and video<br>cameras | The imaging<br>program for X-ray<br>and color images |
| Image<br>Processing<br>Functionality | Enhancement.<br>annotation,<br>measurement,<br>import/export and<br>printing. | Enhancement,<br>annotation,<br>measurement,<br>import/export and<br>printing. | Enhancement<br>and archiving<br>images. | Enhancement,<br>annotation,<br>measurement,<br>import/export and<br>printing. |
| Host Platform | PC | PC & Apple Mac | PC & Apple Mac | PC |
| Host Operating<br>System | Windows 7<br>Professional<br>(32/64-bit)<br>Windows 8<br>Professional<br>(32/64-bit)<br>Windows XP<br>Professional<br>(32/64-bit)<br>Windows Vista<br>Business (32/64-<br>bit)<br>Windows Server<br>2003<br>Windows Server<br>2008 | Windows XP<br>Professional SP3<br>(32 bit)<br>Windows Vista<br>Business SP2 (32<br>bit)<br>Windows 7<br>Professional,<br>Ultimate,<br>Enterprise, all SP1<br>(32 and 64 bit)<br>Windows Server<br>2003<br>Windows Server<br>2008 | Windows 7 Pro<br>(32 or 64 bit)<br>Windows 8.1 Pro<br>(32 or 64 bit)<br>Windows 10 (64<br>bit)<br>Windows 2008<br>Server (64 bit)<br>Windows 2012<br>Server (64 bit)<br>Mac OS X (Intel) | Windows 7<br>Professional/<br>Ultimate/<br>Enterprise SP1 (32<br>or 64-bit)<br>Windows 8/8.1<br>Professional/<br>Enterprise (32 or<br>64-bit)<br>Windows 10<br>Windows Server<br>2012/2012R2 |
| Host RAM | 1024 MB<br>minimum, 2048<br>MB<br>recommended | Workstations: 1 GB<br>or higher<br>Servers: 1 GB or<br>higher | Workstations: 3/ 8<br>GB<br>Servers: 3/ 8 GB | 4 GB |
| Host magnetic<br>storage | 30 GB minimum,<br>200 GB<br>recommended | Workstations: 80<br>GB or larger<br>Servers: 120 GB or<br>larger | Workstation: 80<br>GB<br>Servers: 2 x 500<br>GB | 8 GB free space<br>10 GB hard disk<br>database |
| Host floppy<br>drives | Not required | Not required | Not required | Not required |
| Installation<br>Media | DVD or Network | CD/DVD, USB and<br>network download | DVD ROM or<br>R/W drive | DVD or Network |
| Feature | VixWin Platinum<br>(K141451)<br>(Predicate) | DEXIS Software<br>(K140445)<br>(Predicate) | Romexis<br>(K140713)<br>(Predicate) | Cliniview<br>(Proposed) |
| Host Processor<br>Speed | Pentium 4 2.0<br>GHz min,<br>Pentium 4 3.2<br>GHz<br>recommended | Windows: Intel®<br>Pentium® 4 or<br>higher | Processor Intel<br>Core 2 Duo 2<br>GHz or better | Intel Core i3 or<br>better |
| Host Monitor<br>Size | SVGA with<br>0.25/0.26 dot<br>pitch | Windows: SVGA,<br>XGA<br>recommended | Full HD | 19" or larger<br>recommended |
| Display<br>resolution | 1024 x 768 24 bit<br>true color min, 32<br>bit true color<br>recommended | Windows: 800 x<br>600 with a<br>minimum of .25<br>dot pitch<br>Mac: 1280 x 768<br>pixels minimum | 1280 x 1024<br>(1920x1080<br>recommended) | 1280 x 1024<br>resolution<br>24-bit color<br>Monitor must<br>provide a<br>brightness of<br>300cd/m2 for<br>rooms < 1000 lux<br>Monitor must<br>provide a minimum<br>contrast ratio of<br>100:1 |
| User Display<br>Preferences | Yes | Yes | Yes | Yes |
| USB and S<br>Video support | USB and S Video<br>support | USB and S Video<br>support | USB support | USB and S Video<br>support |
| Receive<br>Images from<br>other Systems | Yes | Yes | Yes | Yes |
| Images<br>Displayed | 2D dental X-<br>rays, intraoral<br>and extraoral<br>images | 2D dental X-rays,<br>intraoral and<br>extraoral Images | 2D and 3D<br>dental X-rays,<br>intraoral and<br>extraoral images | 2D dental X-rays,<br>intraoral and<br>extraoral images |
| Database | Images and<br>related data are<br>stored in the<br>VixWin Platinum<br>database or<br>remotely<br>accessible<br>database in the<br>network. | Images and<br>metadata are<br>stored in the<br>DEXIS database. | Images and<br>metadata are<br>stored in the<br>Romexis<br>database. | Images and<br>related data are<br>stored in the<br>Cliniview<br>database or<br>remotely<br>accessible<br>database in the<br>network. |
| Image<br>Acquisition | Imaging plate<br>scanners,<br>intraoral<br>sensors,<br>intra oral video<br>camera, | Digitizing film with<br>a flatbed scanner,<br>or color images<br>from intra-oral and<br>extra-oral dental<br>cameras | Imaging plate<br>scanners,<br>intraoral<br>sensors,<br>intra oral video<br>camera, | Imaging plate<br>scanners,<br>intraoral sensors,<br>intra oral video<br>camera, |
| Feature | VixWin Platinum<br>(K141451)<br>(Predicate) | DEXIS Software<br>(K140445)<br>(Predicate) | Romexis<br>(K140713)<br>(Predicate) | Cliniview<br>(Proposed) |
| | digital extra oral<br>x-ray devices,<br>various image<br>file formats | digital extra oral<br>x-ray devices,<br>various image<br>file formats | digital extra oral<br>x-ray devices,<br>various image<br>file formats | digital extra oral x-<br>ray devices,<br>various image file<br>formats |
| Viewers /<br>Modes | Panoramic,<br>Cephalometric,<br>CBCT, Intra-oral,<br>color<br>photographs | Panoramic,<br>Cephalometric,<br>CBCT, Intra-oral,<br>color photographs | Intraoral<br>Panoramic<br>Cephalometric<br>2D linear<br>tomography<br>Photos<br>Stack images<br>3D CBCT<br>3D photo<br>3D surface scan | Panoramic,<br>Cephalometric,<br>CBCT, Intra-oral,<br>color photographs |
| Implant<br>Planning | Not included | Implant library,<br>which can be<br>used for implant<br>planning<br>searching for<br>implants. | Optional implant<br>library, which<br>can be used for<br>implant planning,<br>searching for<br>implants,<br>creating new<br>implants,<br>modifying,<br>adding and<br>replacing<br>implants in the<br>plan. | Implant library,<br>which can be used<br>for implant<br>planning,<br>searching for<br>implants, creating<br>new implants,<br>modifying, adding<br>and replacing<br>implants in the<br>plan. |
| Supports<br>Mobile<br>Application | No | No | iPad and iPhone<br>application | iPad application |

# Table 7-1

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Image /page/7/Picture/0 description: The image shows the text "Palodex Group". The word "Palodex" is in a larger, bolder font and is placed on the top left. The word "Group" is in a smaller font and is placed on the bottom right, slightly overlapping with the word "Palodex".

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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.