(57 days)
Not Found
No
The document describes standard dental imaging software functionalities like acquisition, display, processing, editing, storage, and distribution. There is no mention of AI, ML, or any features that would typically be associated with these technologies, such as automated analysis, diagnosis support beyond visualization, or predictive capabilities. The focus is on image management and basic manipulation.
No.
The document explicitly states that SOTA Cloud Imaging is "imaging software designed for use in dentistry" and is used for "image acquisition, organization, and annotation," assisting in "case diagnosis, review, and treatment planning." It processes images from devices like X-ray sensors and cameras, but it does not directly perform any therapeutic function. The software itself is for diagnostic and non-diagnostic purposes, and the "Diagnosis is not performed by this software but by doctors and other qualified individuals."
Yes
The text explicitly states: "SOTA Cloud Imaging is also intended for use for diagnostic and non-diagnostic purposes in the field of Dentistry by dental professionals who are responsible for providing dental care." It also mentions "assisting in case diagnosis."
Yes
The device description explicitly states, "SOTA Cloud Imaging is a software-only dental image device." While it interacts with hardware (standard PC hardware, dental imaging devices), the device itself, as described, is solely the software application.
Based on the provided information, SOTA Cloud Imaging is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. These tests are performed in vitro (in a lab setting, outside the body).
- SOTA Cloud Imaging's Function: SOTA Cloud Imaging is a software application that processes, stores, and displays medical images (specifically dental radiographs and color images). It does not perform any tests on biological samples. Its function is related to the management and visualization of images acquired from imaging devices.
- Intended Use: The intended use clearly states that it is for acquiring, displaying, processing, editing, reviewing, storing, printing, and distributing images for diagnostic and non-diagnostic purposes in dentistry. It does not mention any testing of biological samples.
- Device Description: The description reinforces that it is a dental imaging software that works with imaging devices like X-ray sensors and intraoral cameras. It focuses on image management and visualization.
- Lack of Biological Sample Testing: There is no mention of handling or testing any biological samples throughout the document.
Therefore, SOTA Cloud Imaging falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SOTA Cloud Imaging is indicated for use as a clinical software application that receives images and data from Clio or Clio Prime sensors and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, SOTA Cloud Imaging enables the storage of clinical notes and clinical exam data.
SOTA Cloud Imaging is intended to acquire, display, process, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images using standard PC hardware. SOTA Cloud Imaging is also intended for use for diagnostic and non-diagnostic purposes in the field of Dentistry by dental professionals who are responsible for providing dental care.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
SOTA Cloud Imaging is a cloud-based dental imaging software that allows access to diagnostic images on any PC with an active internet connection. SOTA Cloud Imaging's single page application design makes the inbrowser imaging experience fast, familiar, and simple to operate. SOTA Cloud Imaging is feature rich, including full feature parity with traditional client-server based dental imaging software. With SOTA Cloud Imaging, you can use digital dental imaging devices in a manner consistent with your existing imaging solutions, and bridge patient information either from your existing client-server-based practice management software or modern cloud-based practice management software.
SOTA Cloud Imaging is a Class II dental imaging software that includes the ability to acquire, view, annotate, and organize dental radiographs and color images. SOTA Cloud Imaging integrates with most major client-server and web-based practice management software. Images stored using SOTA Cloud Imaging are saved using lossless compression, and can be exported as DICOM, PNG, JPEG, or PDF files.
SOTA Cloud Imaging is a software-only dental image device which allows the user to acquire images using standard dental imaging devices, such as intraoral X-ray sensors and intraoral cameras.
SOTA Cloud Imaging is imaging software designed for use in dentistry. The main SOTA Cloud Imaging software functionality includes image acquisition, organization, and annotation. SOTA Cloud Imaging is used by dental professional for the visualization of patient images retrieved from a dental imaging device or scanner, for assisting in case diagnosis, review, and treatment planning. Doctors, dental clinicians, and other qualified individuals can display and review images, apply annotations, and manipulate images.
SOTA Cloud Imaging is a standalone product but is designed to work cooperatively with dental practice management software that is used for scheduling, clinical note taking, and billing,
The software operates upon standard PC hardware and displays images on the PC's connected display/monitor.
SOTA Cloud Imaging neither contacts the patient nor controls any life sustaining devices. Diagnosis is not performed by this software but by doctors and other qualified individuals. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray sensors, radiographic devices, digital video capture devices, generic image devices such as scanners, intraoral cameras, flatbed scanners, digital cameras
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended User: dental professionals
Care Setting: dental facilities, dental practices, dental office
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)
SOTA Imaging has conducted extensive non-clinical (bench) performance testing and validation and verification testing of SOTA Cloud Imaging. All the different components of the SOTA Cloud Imaging have been stress tested to ensure that the SOTA Cloud Imaging provides all the capabilities necessary to operate in a manner substantially equivalent to the XV Web predicate.
SOTA Imaging has performed performance testing to compare SOTA Cloud Imaging to the XV Web predicate. Based on the performance testing of the XV Web predicate and SOTA Cloud Imaging, SOTA Cloud Imaging is substantially equivalent in performance specification to the XV Web predicate. Test information can be located within the Software Documentation included with this submission.
Additionally, the results of the performance testing, which included positive and negative testing against the device requirements, predicate testing and human factors testing, has demonstrated that SOTA Cloud Imaging is safe and effective for its intended use and that SOTA Cloud Imaging is substantially equivalent to the currently marketed XV Web predicate.
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/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized design. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.
Sota Precision Optics, Inc. dba SOTA Imaging % Mr. W. Edward Johansen Official Correspondent 1073 North Batavia Street, Suite B ORANGE CA 90404
Re: K210682
Trade/Device Name: SOTA Cloud Imaging Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 9, 2021 Received: March 10, 2021
Dear Mr. Johansen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
May 4, 2021
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210682
Device Name
SOTA Cloud Imaging
Indications for Use (Describe)
SOTA Cloud Imaging is indicated for use as a clinical software application that receives images and data from Clio or Clio Prime sensors and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, SOTA Cloud Imaging enables the storage of clinical notes and clinical exam data.
SOTA Cloud Imaging is intended to acquire, display, process, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images using standard PC hardware. SOTA Cloud Imaging is also intended for use for diagnostic and non-diagnostic purposes in the field of Dentistry by dental professionals who are responsible for providing dental care.
| 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
510(k) Summary
K210682
Dated: April 30, 2021
A. Submitter's Name: Sota Precision Optics, Inc. dba SOTA Imaging
Address: 1073 North Batavia Street, Suite B, Orange, California 92867
Telephone: (714) 532-6100
Official Correspondent: W. Edward Johansen,
Telephone: (310) 795-7425
E-mail address: wedjohansen@msn.com
Address: 1239 Stanford Street, #205, Santa Monica, California 90404
B. Identification of New Device
Owner/Operator/Manufacturer: SOTA Imaging
Establishment Registration Number: 3000190675
510(k) Premarket Notification Number: K210682
Trade Name: SOTA Cloud Imaging
Common Name: Dental imaging software
Classification Name: Medical Image Management and Processing System
Product Code: LLZ
Classification: Class II
Panel: Radiology
Class: II
Panel: Radiology
Regulation Number: 21 C.F.R. §892.2050
C. Identification of Predicate Device
Owner/Operator/Manufacturer: Apertyx, Inc.
4
510(k) Premarket Notification Number: K132342
Trade Name: XV Web
Common Name: Dental imaging software
Classification Name: Medical Image Management and Processing System
Product Code: LLZ
Classification: Class II
Panel: Radiology
Requlation: Number: 21 C.F.R. §892.2050
D. Device Description
SOTA Cloud Imaging is a cloud-based dental imaging software that allows access to diagnostic images on any PC with an active internet connection. SOTA Cloud Imaging's single page application design makes the inbrowser imaging experience fast, familiar, and simple to operate. SOTA Cloud Imaging is feature rich, including full feature parity with traditional client-server based dental imaging software. With SOTA Cloud Imaging, you can use digital dental imaging devices in a manner consistent with your existing imaging solutions, and bridge patient information either from your existing client-server-based practice management software or modern cloud-based practice management software.
SOTA Cloud Imaging is a Class II dental imaging software that includes the ability to acquire, view, annotate, and organize dental radiographs and color images. SOTA Cloud Imaging integrates with most major client-server and web-based practice management software. Images stored using SOTA Cloud Imaging are saved using lossless compression, and can be exported as DICOM, PNG, JPEG, or PDF files.
SOTA Cloud Imaging is a software-only dental image device which allows the user to acquire images using standard dental imaging devices, such as intraoral X-ray sensors and intraoral cameras.
SOTA Cloud Imaging is imaging software designed for use in dentistry. The main SOTA Cloud Imaging software functionality includes image acquisition, organization, and annotation. SOTA Cloud Imaging is used by
5
dental professional for the visualization of patient images retrieved from a dental imaging device or scanner, for assisting in case diagnosis, review, and treatment planning. Doctors, dental clinicians, and other qualified individuals can display and review images, apply annotations, and manipulate images.
SOTA Cloud Imaging is a standalone product but is designed to work cooperatively with dental practice management software that is used for scheduling, clinical note taking, and billing,
The software operates upon standard PC hardware and displays images on the PC's connected display/monitor.
SOTA Cloud Imaging neither contacts the patient nor controls any life sustaining devices. Diagnosis is not performed by this software but by doctors and other qualified individuals. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.
E. Intended Use
SOTA Cloud Imaging software is designed for use by dental practices for tracing and presenting patient images which are utilized by dental professionals to assist in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed dental practitioners.
SOTA Cloud Imaging is indicated for use as a clinical software application that receives images and data from Clio or Clio Prime x-ray sensors and various other imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, SOTA Cloud Imaging enables the storage of clinical notes and clinical exam data.
It is intended to acquire, display, process, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images using standard PC hardware.
SOTA Cloud Imaging interacts with imaging devices connected to a Windows PC. SOTA Cloud Imaging controls the direct capture of digital xray images from Clio and Clio Prime intraoral x-ray sensors and other FDA
6
approved radiographic imaging devices, views and captures live image from intraoral cameras via USB 2.0 or video capture card, imports images from various sources such as radiographic devices, flatbed scanners, digital cameras, and generic image devices, exports, e-mail, prints images, processes digital images with several tools to enhance their diagnostic value, and creates a database of patients and store images in patient folders on cloud server storage.
F. Indications for Use
SOTA Cloud Imaging is indicated for use as a clinical software application that receives images and data from Clio or Clio Prime sensors and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, SOTA Cloud Imaging enables the storage of clinical notes and clinical exam data.
SOTA Cloud Imaging is intended to acquire, display, process, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images using standard PC hardware. SOTA Cloud Imaging is also intended for use for diagnostic and non-diagnostic purposes in the field of Dentistry by dental professionals who are responsible for providing dental care.
G. Technical Characteristics
SOTA Cloud Imaging is a software only device that is operated by users via a modern web-browser. On the server side, SOTA Cloud Imaging is written in C# and runs in a stateless containerized environment. SOTA Cloud Imaging uses Microsoft Azure SQL databases and Microsoft Azure Blob storage to store application metadata and images. On the client-side, SOTA Cloud Imaging executes in a modern web-browser using HTML5, CSS3, and JavaScript.
H. Off-the-Shelf Software
SOTA Imaging has conducted an appropriate hazard analysis and basic documentation of all off-the-shelf software prior to its utilization in the SOTA Cloud Imaging product, in accordance with the OTS Software Decision Schematic in the FDA guidance document entitled "Off-The-Shelf Software Use in medical Devices" issued on September 27th, 2019. All included offthe-shelf software is used strictly in non-diagnostic capacity and is not directly interacted with by the user. The off-the-shelf software used in this product is documented in the Software Information section of this filing.
7
I. Summary of Non-Clinical (bench) Performance Testing
SOTA Imaging has conducted extensive non-clinical (bench) performance testing and validation and verification testing of SOTA Cloud Imaging. All the different components of the SOTA Cloud Imaging have been stress tested to ensure that the SOTA Cloud Imaging provides all the capabilities necessary to operate in a manner substantially equivalent to the XV Web predicate.
J. Summary of Clinical Performance Testing
SOTA Imaging has performed performance testing to compare SOTA Cloud Imaging to the XV Web predicate. Based on the performance testing of the XV Web predicate and SOTA Cloud Imaging, SOTA Cloud Imaging is substantially equivalent in performance specification to the XV Web predicate. Test information can be located within the Software Documentation included with this submission.
Additionally, the results of the performance testing, which included positive and negative testing against the device requirements, predicate testing and human factors testing, has demonstrated that SOTA Cloud Imaging is safe and effective for its intended use and that SOTA Cloud Imaging is substantially equivalent to the currently marketed XV Web predicate.
K. Non-Applicable Requirements
SOTA Cloud Imaging is a software product. Therefore, the requirement of Sterilization does not apply.
SOTA Cloud Imaging is a software product. Therefore, the requirement of specifying Shelf Life does not apply.
SOTA Cloud Imaging does not contain patient contacting elements. Therefore, the requirement for Biocompatibility does not apply.
SOTA Cloud Imaging is a software product which does not have electronic components. Therefore, the requirement of Electromagnetic Compatibility does not apply.
SOTA Cloud Imaging is a software product which does not have electronic components. Therefore, the requirement of Electrical Safety does not apply.
8
L. Summary of Animal Performance Testing
Based on the device hazard analysis and classification SOTA Imaging has not performed animal performance testing to compare SOTA Cloud Imaging to the XV Web predicate.
M. Comparing SOTA Cloud Imaging to the XV Web predicate
The following comparison table compares SOTA Cloud Imaging to the XV Web predicate with respect to intended use, indications of use, environment of use. limitations of use, technical performance and technological characteristics and provides additional information regarding the basis for the determination of substantial equivalence.
N. SOTA Cloud Imaging and the XV Web Predicate Differences
Unlike the XV Web predicate device. SOTA Cloud Imaging does not require the installation of a separate image acquisition user interface, outside of the cloud-based web application.
None of the above-mentioned differences in features changes any of the Safety or Effectiveness or Indications for Use of SOTA Cloud Imaging as compared to the XV Web predicate.
O. Substantial Equivalence Rationale
SOTA Imaging has conducted extensive performance testing for validation and verification of SOTA Cloud Imaging and has done analysis to compare SOTA Cloud Imaging to the XV Web predicate. Based on this testing analysis SOTA Cloud Imaging provides all the capabilities necessary to operate in a manner substantially equivalent to the XV Web predicate. The comparison table compares SOTA Cloud Imaging to the XV Web predicate with respect to intended use, indications of use, environment of use, limitations of use, technical performance, and technological characteristics. The comparison chart provides additional information regarding the basis for the determination of substantial equivalence. Additionally, the results of the performance testing demonstrate that SOTA Cloud Imaging is safe and effective for its intended use. Based on the intended use, product design, performance and software information provided in this notification, SOTA Cloud Imaging is considered substantially equivalent to the currently marketed XV Web predicate.
9
Comparison table
| 510(k) Number | K132342 | K210682 |
|---|---|---|
| Device Name | XV Web | SOTA Cloud Imaging |
| Classification Name | Picture Archiving and | |
| Communications | ||
| System (PACS) | Medical Image | |
| Management | ||
| and Processing System | ||
| Common\Usual name | Dental Imaging | |
| Software | Dental Imaging | |
| Software | ||
| Manufacturer | Apteryx, Inc. | SOTA Precision |
| Optics, Inc. dba SOTA | ||
| Imaging | ||
| Classification | Class II | Class II |
| Regulation Number | 892.2050 | 892.2050 |
| Product Code | LLZ | LLZ |
| Classification panel | Radiology | Radiology |
| Medical Specialty | Dentistry | Dentistry |
| Implementation | Dental Office | Dental Office |
| Host Platform | Web Based Software | |
| Application | Web Based Software | |
| Application | ||
| Intended Use | XV Web is a Picture | |
| Archiving and | ||
| Communications | ||
| System (PACS) that | ||
| enables dental facilities | ||
| to query and access | ||
| digitally stored hard | ||
| and soft tissue intraoral | ||
| /extraoral radiological | ||
| images using an | ||
| internet/web browser. | ||
| A web-based interface | ||
| provides users the | ||
| needed functionality to | ||
| display patient images | ||
| and studies in | ||
| commercially available | ||
| web browsers. Patient | ||
| images/studies can be | ||
| accessed by users | SOTA Cloud Imaging | |
| is indicated for use as | ||
| a clinical software | ||
| application that | ||
| receives images and | ||
| data from Clio or Clio | ||
| Prime x-ray sensors | ||
| and various other | ||
| imaging sources (e.g., | ||
| radiographic devices, | ||
| digital video capture | ||
| devices, and generic | ||
| image devices such as | ||
| scanners). In addition, | ||
| SOTA Cloud Imaging | ||
| enables the storage of | ||
| clinical notes and | ||
| clinical exam data. | ||
| It is intended to | ||
| acquire, display | ||
| locally within the | process, edit (e.g., | |
| system or across a | resize, adjust contrast, | |
| wide-area network at | annotate, etc.), review, | |
| distributed locations. | store, print, and | |
| Acquisition can be | distribute images using | |
| included via integration | standard PC hardware. | |
| with a DICOM- | SOTA Cloud Imaging | |
| compatible imaging | controls the direct | |
| application or server | capture of digital x-ray | |
| configured to forward | images from Clio and | |
| images to the XV Web | Clio Prime intraoral x- | |
| database. The system | ray sensors and other | |
| allows users to: | FDA approved | |
| manipulate (e.g., | radiographic imaging | |
| rotate, flip, etc.): | devices, views and | |
| enhance (e.g., | captures live image | |
| increase or decrease | from intraoral cameras | |
| brightness/contrast, | via USB 2.0 or video | |
| gamma correction); | capture card, imports | |
| add labels (e.g., | images from various | |
| measurements, lines, | sources such as | |
| arrows, etc.), | radiographic devices, | |
| annotations to patient | flatbed scanners, | |
| images/studies and | digital cameras, and | |
| other relevant | generic image devices, | |
| operations for | exports, e-mail, prints | |
| diagnostic purposes. | images, processes | |
| XV Web is designed | digital images with | |
| for medium-to-large | several tools to | |
| dental practices and is | enhance their | |
| intended for trained | diagnostic value, and | |
| dental professionals | creates a database of | |
| and technicians to | patients and store | |
| access, manipulate, | images in patient | |
| and enhance dental | folders on cloud server | |
| images for diagnostic | storage. | |
| purposes only. | ||
| Indications for Use | XV Web is a Picture | SOTA Cloud Imaging |
| Archiving and | is indicated for use as | |
| Communications | a clinical software | |
| System (PACS) that | ||
| enables dental facilities | ||
| to query and access | ||
| digitally stored hard | ||
| and soft tissue | ||
| intraoral/extraoral | ||
| radiological images | ||
| using an internet/web | ||
| browser. A web-based | ||
| interface provides | ||
| users the needed | ||
| functionality to display | ||
| patient images and | ||
| studies in commercially | ||
| available web | ||
| browsers. Patient | ||
| images/studies can be | ||
| accessed by users | ||
| locally within the | ||
| system or across a | ||
| wide-area network at | ||
| distributed locations. | ||
| Acquisition can be | ||
| included via integration | ||
| with a DICOM - | ||
| compatible Imaging | ||
| and/or PACS system | ||
| configured to forward | ||
| images to the XV Web | ||
| database. XV Web is | ||
| compatible with | ||
| programs that run on | ||
| standard "off-the-shelf | ||
| personal computers, | ||
| business computers, | ||
| and servers running | ||
| standard operating | ||
| systems. The system | ||
| allows users to: | ||
| manipulate (e.g | application that | |
| receives images and | ||
| data from Clio or Clio | ||
| Prime sensors and | ||
| various imaging | ||
| sources (e.g., | ||
| radiographic devices, | ||
| digital video capture | ||
| devices, and generic | ||
| image devices such as | ||
| scanners). In addition, | ||
| SOTA Cloud Imaging | ||
| enables the storage of | ||
| clinical notes and | ||
| clinical exam data. | ||
| SOTA Cloud Imaging | ||
| is intended to acquire, | ||
| display, process, edit | ||
| (e.g., resize, adjust | ||
| contrast, annotate, | ||
| etc.), review, store, | ||
| print, and distribute | ||
| images using standard | ||
| PC hardware. SOTA | ||
| Cloud Imaging is also | ||
| intended for use for | ||
| diagnostic and non- | ||
| diagnostic purposes in | ||
| the field of Dentistry by | ||
| dental professionals | ||
| who are responsible | ||
| for providing dental | ||
| care. | ||
| rotate, flip, etc.); | ||
| enhance (e.g., | ||
| increase or decrease | ||
| brightness/contrast, | ||
| gamma correction); | ||
| add labels (e.g., | ||
| measurements, lines, | ||
| arrows, etc.), | ||
| annotations to patient | ||
| images/studies and | ||
| other relevant | ||
| operations for | ||
| diagnostic purposes. | ||
| XV Web is designed | ||
| for medium to large | ||
| dental practices and is | ||
| intended for trained | ||
| dental professionals | ||
| and technicians to | ||
| access, manipulate, | ||
| and enhance dental | ||
| images for diagnostic | ||
| Features | purposes only. | |
| Browsing images by | ||
| date and/or source | ||
| Viewing an Image | ||
| Uploading an Image | ||
| file (via integration with | ||
| DICOM-compatible | ||
| imaging application or | ||
| PACS) | ||
| Acquiring an Image | ||
| from a Web camera | ||
| (via integration with | ||
| DICOM-compatible | ||
| imaging application) | Browsing images by | |
| date and/or source | ||
| Viewing an Image | ||
| Uploading an Image | ||
| file | ||
| Acquiring an Image | ||
| from a Web cam | ||
| Acquiring an Image | ||
| from a TWAIN device | ||
| (via integration with | Acquiring an Image | |
| from a TWAIN device | ||
| DICOM-compatible | ||
| imaging application) | ||
| Acquiring an image | ||
| from standard dental | ||
| imaging devices (via | ||
| integration with | ||
| DICOM-compatible | ||
| imaging application) | ||
| Copying an Image to | ||
| the local computer | ||
| Add labels and | ||
| annotations on patient | ||
| images (Text, lines, | ||
| arrows, ect.) | ||
| Saving a Modified | ||
| Image | ||
| Saving an Image that | ||
| has been modified with | ||
| labels/overlays. | ||
| Annotating an Image | ||
| Zooming in on an | ||
| Image | ||
| Inverting Colors on an | ||
| Image | ||
| Rotating an Image | ||
| (increments of 90 | ||
| degrees) | ||
| Flipping an Image | ||
| Horizontally or | ||
| Vertically | ||
| Image contrast | ||
| Increase and decrease | ||
| image contrast | ||
| Increase and decrease | ||
| image brightness, | ||
| Adjust gamma function | ||
| N/A | ||
| N/A | Acquiring an image | |
| from standard dental | ||
| imaging devices | ||
| Copying an Image to | ||
| the local computer | ||
| Saving a Modified | ||
| Image | ||
| Annotating an Image | ||
| Zooming in on an | ||
| Image | ||
| Inverting Colors on an | ||
| Image | ||
| Rotating an image | ||
| (increments of 90 | ||
| degrees) | ||
| Flipping an image | ||
| Horizontally or | ||
| Vertically | ||
| N/A | ||
| Increase and decrease | ||
| contrast | ||
| Increase and decrease | ||
| brightness | ||
| Adjust gamma function | ||
| Spotlight sharpness | ||
| enhancement tool | ||
| Staff audit logging | ||
| Technical | ||
| Characteristics | ||
| N/A/ | ||
| Cropping image | ||
| Inverting colors of an | ||
| image | ||
| Web-based application | ||
| and interface | ||
| Secure data | ||
| transmission (HTTPS) | ||
| Database | ||
| Management and | ||
| Storage | ||
| Secure server and | ||
| Infrastructure | Staff software-use | |
| analytics | ||
| N/A | ||
| N/A | ||
| Responsive single | ||
| page web-based | ||
| application and | ||
| interface | ||
| Secure data | ||
| transmission (HTTPS, | ||
| TLS v1.2) | ||
| Secure Database | ||
| Management and | ||
| Storage | ||
| Secure server and | ||
| Infrastructure | ||
| Multi-zone redundant, | ||
| highly available | ||
| DICOM Compliant | DICOM File Compliant | |
| Lossless Image | ||
| Compression | Lossless Image | |
| Compression | ||
| Zoom Depth, fit and | ||
| relative | ||
| XV Web is designed | ||
| for medium to large | ||
| dental practices and is | ||
| intended for trained | ||
| dental professionals | ||
| and technicians to | ||
| access, manipulate | ||
| and enhance dental | ||
| images for diagnostic | ||
| and non-diagnostic | ||
| purposes. | SOTA Cloud Imaging | |
| is designed for single | ||
| dental practice, group | ||
| dental practice, and | ||
| corporate dental | ||
| service organization | ||
| environments. SOTA | ||
| Cloud Imaging is | ||
| intended for trained | ||
| dental professionals | ||
| and technicians to | ||
| access, manipulate, | ||
| and enhance dental | ||
| images for diagnostic | ||
| and non-diagnostic | ||
| purposes. |
10
11
12
13
14
15
P. Recognized Standards and Not Recognized Standard
SOTA Cloud Imaging is software that conforms to the following recognized standards.
13-79 ISO 14971: Medical Devices-Application of Risk Management to Medical Devices
5-125 IEC 62304: Medical Device Software-Software Life Cycle Processes
NR ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
Q. Conclusion
Based on the comparison of intended use, indications for use and technological characteristics, SOTA Cloud Imaging is substantially equivalent to the XV Web predicate. SOTA Imaging has conducted extensive performance testing for validation and verification indicating that SOTA Cloud Imaging provides reliable post-processing information to ensure that SOTA Cloud Imaging provides all the capabilities necessary to operate in a manner substantially equivalent to the XV Web predicate.