(202 days)
Not Found
No
The summary describes standard image processing, storage, and viewing functionalities common in dental imaging software, with no mention of AI, ML, or related concepts.
No.
The software is indicated for general dental and maxillofacial diagnostic imaging, controlling capture, display, enhancement, and saving of digital images. It is not described as providing treatment or therapy.
Yes
The "Intended Use / Indications for Use" states that "Cliniview software program is indicated for general dental and maxillofacial diagnostic imaging." This explicitly indicates its use for diagnosis.
No
The device description explicitly states that the software controls the capture of images from "various digital imaging systems" including "imaging plates, intraoral sensors and digital X-ray imaging devices." While the software itself is a component, it is intrinsically linked to and controls hardware for image acquisition, making it more than just a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general dental and maxillofacial diagnostic imaging." This involves capturing, displaying, enhancing, and storing images from various imaging systems. This is related to medical imaging, not in vitro testing of biological samples.
- Device Description: The description focuses on software functionalities related to image handling, patient management, and interfaces with imaging devices and other systems. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is a medical imaging software program used for dental and maxillofacial diagnosis based on images, not on in vitro analysis of biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image acquisition supports imaging plates, intraoral sensors and digital X-ray imaging devices. Images can also be imported from other digital sources.
Anatomical Site
Dental and maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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.
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.
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
§ 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
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
1
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
2
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 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."
3
Image /page/3/Picture/0 description: The image shows the word "Palodex" in a bold, sans-serif font. Below and to the right of "Palodex" is the word "Group" in a smaller font size. The text is black against a white background.
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
4
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.
5
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
(K141451)
(Predicate) | DEXIS Software
(K140445)
(Predicate) | Romexis
(K140713)
(Predicate) | Cliniview
(Proposed) |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use / Intended
Use | VixWin Platinum
is a software
program 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 DEXIS
Software is a
software program
for general dental
and maxillofacial
diagnostic imaging.
It controls capture,
display,
enhancement and
saving of X-ray
digital images from
digital imaging
systems. It can
also handle other
types of images
acquired by
digitizing film with a
flatbed scanner, or
color images
from intra-oral and
extra-oral dental
cameras. | 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. | 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. |
| Implementation | Software only | Software only | Software only | Software only |
| Feature | VixWin Platinum
(K141451)
(Predicate) | DEXIS Software
(K140445)
(Predicate) | Romexis
(K140713)
(Predicate) | Cliniview
(Proposed) |
| Overall
Functionality | The imaging
program for X-ray
and color images | The imaging
program for X-ray
and color images | The imaging
software for
digital imaging
devices and video
cameras | The imaging
program for X-ray
and color images |
| Image
Processing
Functionality | Enhancement.
annotation,
measurement,
import/export and
printing. | Enhancement,
annotation,
measurement,
import/export and
printing. | Enhancement
and archiving
images. | Enhancement,
annotation,
measurement,
import/export and
printing. |
| Host Platform | PC | PC & Apple Mac | PC & Apple Mac | PC |
| Host Operating
System | Windows 7
Professional
(32/64-bit)
Windows 8
Professional
(32/64-bit)
Windows XP
Professional
(32/64-bit)
Windows Vista
Business (32/64-
bit)
Windows Server
2003
Windows Server
2008 | Windows XP
Professional SP3
(32 bit)
Windows Vista
Business SP2 (32
bit)
Windows 7
Professional,
Ultimate,
Enterprise, all SP1
(32 and 64 bit)
Windows Server
2003
Windows Server
2008 | Windows 7 Pro
(32 or 64 bit)
Windows 8.1 Pro
(32 or 64 bit)
Windows 10 (64
bit)
Windows 2008
Server (64 bit)
Windows 2012
Server (64 bit)
Mac OS X (Intel) | Windows 7
Professional/
Ultimate/
Enterprise SP1 (32
or 64-bit)
Windows 8/8.1
Professional/
Enterprise (32 or
64-bit)
Windows 10
Windows Server
2012/2012R2 |
| Host RAM | 1024 MB
minimum, 2048
MB
recommended | Workstations: 1 GB
or higher
Servers: 1 GB or
higher | Workstations: 3/ 8
GB
Servers: 3/ 8 GB | 4 GB |
| Host magnetic
storage | 30 GB minimum,
200 GB
recommended | Workstations: 80
GB or larger
Servers: 120 GB or
larger | Workstation: 80
GB
Servers: 2 x 500
GB | 8 GB free space
10 GB hard disk
database |
| Host floppy
drives | Not required | Not required | Not required | Not required |
| Installation
Media | DVD or Network | CD/DVD, USB and
network download | DVD ROM or
R/W drive | DVD or Network |
| Feature | VixWin Platinum
(K141451)
(Predicate) | DEXIS Software
(K140445)
(Predicate) | Romexis
(K140713)
(Predicate) | Cliniview
(Proposed) |
| Host Processor
Speed | Pentium 4 2.0
GHz min,
Pentium 4 3.2
GHz
recommended | Windows: Intel®
Pentium® 4 or
higher | Processor Intel
Core 2 Duo 2
GHz or better | Intel Core i3 or
better |
| Host Monitor
Size | SVGA with
0.25/0.26 dot
pitch | Windows: SVGA,
XGA
recommended | Full HD | 19" or larger
recommended |
| Display
resolution | 1024 x 768 24 bit
true color min, 32
bit true color
recommended | Windows: 800 x
600 with a
minimum of .25
dot pitch
Mac: 1280 x 768
pixels minimum | 1280 x 1024
(1920x1080
recommended) | 1280 x 1024
resolution
24-bit color
Monitor must
provide a
brightness of
300cd/m2 for
rooms