← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K210682
# SOTA Cloud Imaging (K210682)
_Sota Precision Optics, Inc. Dba Sota Imaging · LLZ · May 4, 2021 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K210682
## Device Facts
- **Applicant:** Sota Precision Optics, Inc. Dba Sota Imaging
- **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md)
- **Decision Date:** May 4, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.2050
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Software as a Medical Device
## Intended 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.
## Device Story
Cloud-based dental imaging software; operates on standard PC hardware via web browser. Inputs: digital X-ray images from Clio/Clio Prime sensors, intraoral cameras (USB/video capture), scanners, and generic imaging devices. Function: acquires, displays, processes (resize, contrast adjustment), annotates, stores, and distributes images. Used in dental offices by dental professionals for case diagnosis, review, and treatment planning. Integrates with practice management software. Output: visualized images on PC monitor; exported files (DICOM, PNG, JPEG, PDF). Benefits: enables remote access to diagnostic images, centralized storage, and efficient clinical workflow.
## Clinical Evidence
No clinical data. Bench testing only. Performance testing included verification and validation of software components, positive/negative testing against requirements, and human factors testing to demonstrate safety and effectiveness compared to the XV Web predicate.
## Technological Characteristics
Software-only device; web-based application. Server-side: C#, stateless containerized environment, Microsoft Azure SQL/Blob storage. Client-side: HTML5, CSS3, JavaScript. Connectivity: HTTPS/TLS v1.2. Standards: ISO 14971 (Risk Management), IEC 62304 (Software Life Cycle), ISO 13485:2016 (Quality Management).
## 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
- XV Web ([K132342](/device/K132342.md))
## Submission Summary (Full Text)
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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
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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
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#### 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)
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#### 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.
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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
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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
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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.
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## 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.
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## 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.
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# 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 |
|…
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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K210682](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K210682)
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