(87 days)
No
The summary describes standard medical imaging software with image processing and visualization tools, but there is no mention of AI or ML capabilities. The performance studies focus on comparison with predicate devices for image rendering and stability, not on the performance of any AI/ML algorithms.
No
The device is described as medical imaging software used for displaying, visualizing, processing, and rendering images for diagnostic and preoperative simulation purposes, not for providing direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software is intended to "render, diagnose, review, store, print, and distribute images." Additionally, the "Device Description" mentions that "Typical image enhancement filters and tools are available to assist the user in making diagnosis."
No
The device description explicitly states it is designed to work as a stand-alone or as an accessory to Planmeca imaging and Planmeca dental unit products, which are hardware devices. While the core functionality is software-based image processing and visualization, its intended use and integration with specific hardware components prevent it from being classified as a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device's intended use: The intended use of Planmeca Romexis is clearly stated as a medical imaging software for displaying and visualizing dental and medical 2D and 3D image files from imaging devices (projection radiography and CBCT). It's used for retrieving, processing, rendering, diagnosing, reviewing, storing, printing, and distributing these images. It also has a preoperative function for dental implants and monitoring features for Planmeca devices.
- Lack of specimen analysis: The description focuses entirely on processing and displaying images generated by imaging equipment. There is no mention of analyzing biological specimens from the human body.
Therefore, Planmeca Romexis falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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, review, store, print, and distribute images.
It is also a preoperative software application used for the simulation of dental implants. The software includes monitoring features for Planmeca devices for maintenance purposes. It is designed to work as a stand-alone or as an accessory to Planmeca imaging and Planmeca dental unit products in a standard PC. The software is for use by authorized healthcare professionals.
Planmeca Romexis software is:
- Not intended for capturing optical impressions for dental restorations. .
- Not intended for optically scanning stone models and impressions for dental restorations. ●
- Not intended for optically scanning intraoral preparations for use in designing implants and/or . abutments. .
- Not intended for optically scanning intra-orally for use in orthodontics. .
- . Not intended for mammography use.
Product codes
LLZ
Device Description
Planmeca Romexis is a modular imaging software for dental and medical use. It is divided into modules to provide user access to different workflow steps involving different diagnostic views of images. Patient management screen with search capabilities lets users to find patients and identify correct patient file before starting work with a patient. After creating or selecting patient, new images can be acquired using select Planmeca X-ray units.
Planmeca Romexis is capable of processing and displaying 2D images in different formats and 3D CBCT images in DICOM format. 3D CBCT images can be viewed in near real-time multi projection reconstruction (MPR) views. 2D and 3D image browsers are provided to allow user access to relevant images. Typical image enhancement filters and tools are available to assist the user in making diagnosis but original exposure is always kept in the database for reference.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
projection radiography and CBCT
Anatomical Site
dental and medical
Indicated Patient Age Range
Not Found
Intended User / Care Setting
authorized healthcare professionals.
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 following quality assurance measures were applied to the development of the Software:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Performance testing (Verification)
- Safety testing (Verification) .
- ♥ Final acceptance testing (Validation)
- Bench testing to compare with predicate software ●
Testing confirmed that Planmeca Romexis is stable and operating as designed. Testing also confirmed that Planmeca Romexis has been evaluated for hazards and that the risk has been reduced to acceptable levels.
The non-clinical bench-testing of Planmeca Romexis with predicate software was performed by comparison of images rendered by Planmeca Romexis and the predicate software InVivoDental of Anatomage. This confirms that both software applications are equally effective in performing the essential functions and provide substantially equivalent clinical data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K123519 Anatomage InVivoDental, K061035 Televere Systems TigerView
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the word "PLANMECA" in bold, black letters. To the right of the word, there is the text "K140713" and "Page 1 of 3" in a handwritten font. The text is black and appears to be part of a document or label.
510(k) SUMMARY
JUN 1 6 2014
DATE
May 27, 2014
PRODUCT, CLASSIFICATION NAME
Device name: Planmeca Romexis Common name: System, Image Processing, Radiological Classification: Class II Classification name: Imaging Processing System, LLZ, 21 CFR 892.2050
SUBMITTED BY
Planmeca Oy Asentajankatu 6 00880 Helsinki, Finland Phone: +358 20 7795 500 Fax: +358 20 7795 396 Contact person: Mr. Lars Moring
U.S DESIGNATED AGENT
Planmeca USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: (630) 529 2300 Fax: (630) 529 1929 Contact person: Bob Pienkowski
DEVICE DESCRIPTION
Planmeca Romexis is a modular imaging software for dental and medical use. It is divided into modules to provide user access to different workflow steps involving different diagnostic views of images. Patient management screen with search capabilities lets users to find patients and identify correct patient file before starting work with a patient. After creating or selecting patient, new images can be acquired using select Planmeca X-ray units.
Planmeca Romexis is capable of processing and displaying 2D images in different formats and 3D CBCT images in DICOM format. 3D CBCT images can be viewed in near real-time multi projection
1
Image /page/1/Picture/0 description: The image shows the word "PLANMECA" in bold, black letters. The letters are large and evenly spaced, filling most of the frame. The font appears to be sans-serif, and the overall impression is one of clarity and emphasis.
reconstruction (MPR) views. 2D and 3D image browsers are provided to allow user access to relevant images. Typical image enhancement filters and tools are available to assist the user in making diagnosis but original exposure is always kept in the database for reference.
INDICATIONS FOR USE
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, review, store, print, and distribute images.
It is also a preoperative software application used for the simulation of dental implants. The software includes monitoring features for Planmeca devices for maintenance purposes. It is designed to work as a stand-alone or as an accessory to Planmeca imaging and Planmeca dental unit products in a standard PC. The software is for use by authorized healthcare professionals.
Planmeca Romexis software is:
- Not intended for capturing optical impressions for dental restorations. .
- Not intended for optically scanning stone models and impressions for dental restorations. ●
- Not intended for optically scanning intraoral preparations for use in designing implants and/or . abutments. .
- Not intended for optically scanning intra-orally for use in orthodontics. .
- . Not intended for mammography use.
PREDICATE DEVICES
K123519 Anatomage InVivoDental K061035 Televere Systems TigerView
TECHNOLOGICAL CHARACTERISTICS
Both Planmeca Romexis and the predicate device InVivoDental are software applications with similar characteristics related to managing of 3D image files. Both applications are meant for use with standard PC hardware and include similar major functionality related to display, processing, visualization and sharing of dental and medical 3D image files, such as multiplanar views, volume rendering view, measurements, implant planning, airways visualization, TMJ module, virtual cephalometric and panoramic images and sharing of image files with a viewer.
The main difference is that Planmeca Romexis lacks the capability to make surgical or orthodontic planning.
Both Planmeca Romexis and the predicate device TigerView Professional are software applications with similar characteristics related to managing of 2D image files. Both applications are meant for use with standard PC hardware and include similar major functionality related to display, editing, reviewing, storing, printing, and distributing of 2D image files, such as annotations, adjustments, integration with
2
Image /page/2/Picture/0 description: The image contains the word "PLANMECA" in bold, black letters. Above and to the right of the word, there is handwritten text that reads "K140713 Page 3 of 3". The text is written in black ink and appears to be a document identifier or page number.
practice management systems and distribution of images in Picture Archiving and Communication System (PACS) environment.
NON-CLINICAL TEST RESULTS
. The following quality assurance measures were applied to the development of the Software:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Performance testing (Verification)
- Safety testing (Verification) .
- ♥ Final acceptance testing (Validation)
- Bench testing to compare with predicate software ●
Testing confirmed that Planmeca Romexis is stable and operating as designed. Testing also confirmed that Planmeca Romexis has been evaluated for hazards and that the risk has been reduced to acceptable levels.
The non-clinical bench-testing of Planmeca Romexis with predicate software was performed by comparison of images rendered by Planmeca Romexis and the predicate software InVivoDental of Anatomage. This confirms that both software applications are equally effective in performing the essential functions and provide substantially equivalent clinical data.
SUMMARY
Based on the intended use, product, performance, and testing information provided in this notification, the subject device has been shown to be substantially equivalent in technology, functionality, and indicated use to the currently marketed predicate devices.
3
Image /page/3/Picture/0 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center consists of three curved lines that resemble a stylized human figure or a bird in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002
June 16, 2014
Planmeca Oy % Mr. Lars Moring Regulatory Affairs Manager Asentajankatu 6 Helsinki 00880 FINLAND
Re: K140713
Trade/Device Name: Planmeca Romexis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ. Dated: May 28. 2014 Received: June 2, 2014
Dear Mr. Moring:
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 cither 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
4
Page 2-Mr. Moring
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, piease 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 yours,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement below |
| 510(k) Number (if known) | K140713 |
|---|---|
| Device Name | Planmeca Romexis |
| Indications for Use (Describe) | 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. |
| It is also a preoperative software application used for the simulation and evaluation of dental implants. The software includes monitoring features for Planmeca devices for maintenance purposes. It is designed to work as a stand-alone or as an accessory to Planmeca imaging and Planmeca dental unit products in a standard PC. The software is for use by authorized healthcare professionals. | |
| Planmeca Romexis software is: Not intended for capturing optical impressions for dental restorations.Not intended for optically scanning stone models and impressions for dental restorations.Not intended for optically scanning intraoral preparations for use in designing implants and/or abutments.Not intended for optically scanning intra-orally for use in orthodontics.Not intended for mammography use. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|---|---|
| ------------------------------------------------------------------------------ | -------------------------------------------- |
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