← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K140713 # PLANMECA ROMEXIS (K140713) _Planmeca Oy · LLZ · Jun 16, 2014 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K140713 ## Device Facts - **Applicant:** Planmeca Oy - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Jun 16, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## 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, 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. ## Device Story Planmeca Romexis is modular imaging software for dental/medical use; operates on standard PCs. Inputs include 2D images and 3D CBCT DICOM files from Planmeca X-ray units. Software provides patient management, image acquisition, and visualization tools including multi-projection reconstruction (MPR), volume rendering, measurements, implant planning, airway visualization, and TMJ modules. Enhancements and filters assist diagnosis; original exposures remain in database. Used by authorized healthcare professionals in clinical settings to review, store, and distribute images. Output supports clinical decision-making for dental/medical diagnosis and preoperative implant planning. Includes device monitoring features for maintenance. ## Clinical Evidence Bench testing only. Comparison of images rendered by Planmeca Romexis and predicate InVivoDental confirmed equivalent effectiveness in performing essential functions and providing substantially equivalent clinical data. Quality assurance included risk analysis, requirements/design reviews, and verification/validation testing. ## Technological Characteristics Software application for standard PC hardware. Functions include 2D/3D image display, processing, visualization (MPR, volume rendering), and sharing. Supports DICOM format. Includes image enhancement filters, measurement tools, and device monitoring. No specific material or energy source requirements as it is a software-only device. ## Regulatory 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 - Anatomage InVivoDental ([K123519](/device/K123519.md)) - Televere Systems TigerView ([K061035](/device/K061035.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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, ![](https://i.imgur.com/9999999.png) 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: | | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | | | PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 . FORM FDA 3881 (1/14) . : ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ .. September ... . . . . . . . . . . . . . . . . . . . . . --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K140713](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K140713) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com