(90 days)
No
The description focuses on image management, storage, and basic processing (measurement functions) without mentioning AI/ML terms or capabilities like automated analysis, detection, or diagnosis.
No.
The device is a software for managing and processing dental x-ray images, intended to aid in diagnosis, not to provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the software allows "the user to process and examine the images in order to achieve improved diagnoses." This indicates its role in aiding diagnosis.
Yes
The device is described as "dental x-ray image management software" and its components (Viewer and Server) are software. While it interacts with a hardware device (Cruxcan image plate scanner), the 510(k) is for the software itself.
Based on the provided information, the CRUXVIEW software is not an In Vitro Diagnostic (IVD) device.
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.
- CRUXVIEW's Function: The CRUXVIEW software processes and manages dental x-ray images. These are images of the internal structures of the mouth and teeth, not specimens taken from the body.
- Intended Use: The intended use is to process and examine dental x-ray images to achieve improved diagnoses. This is related to medical imaging, not laboratory testing of biological samples.
- Device Description: The description clearly states it's dental x-ray image management software.
Therefore, the CRUXVIEW falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CRUXVIEW is a software intended for using and managing dental x-ray image sent by Cruxcan image plate scanner, storing the images and allowing the user to process and examine the images in order to achieve improved diagnoses.
Product codes
MUH
Device Description
The CRUXVIEW is dental x-ray image management software which provides various features to acquire, transfer, edit, display, and store scanned dental images which is specifically for a 510k cleared device (K183637), Cruxcan (CRX-1000). It also provides server/client model which allow users to upload and download the images and patient information from any workstations in the network environment.
CRUXVIEW consists of two parts: CRUXVIEW Viewer and CRUXVIEW Server. CRX-1000 sends the scanned image to the CRUXVIEW viewer. The CRUXVIEW viewer sends the received image to the CRUXVIEW Server. The CRUXVIEW Viewer searches the image stored in the CRUXVIEW Server and shows the image to the user. The subject device has various functions for users' needs including length and angle measurement functions. The CRUXVIEW supports DICOM file formats.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Dental x-ray image
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- SW Validation for Viewer & Server
- Performance test for accuracy of measurement function
The test results of the tests performed on the subject device supported that it is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
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July 29, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CRUXELL Corporation % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 IRVINE CA 92620
Re: K211317
Trade/Device Name: CRUXVIEW Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: April 22, 2021 Received: April 30, 2021
Dear Priscilla Chung:
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/cfpmn/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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 mediation-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) K211317
Device Name CRUXVIEW
Indications for Use (Describe)
The CRUXVIEW is a software intended for using and managing dental x-ray image sent by Cruxcan image plate scanner, storing the images and allowing the user to process and examine the images in order to achieve improved diagnoses.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
(K211317)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: July 26, 2021
1. 510K Applicant / Submitter:
CRUXELL Corp. 405, Migun techno World II, 187, Techno 2-ro Yuseonggu, Daejeon, Republic of Korea Tel : +82-42-935-2554 Fax : +82-42-931-2554
2. Submission Contact Person
LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200, Irvine CA 92620 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Trade/Device Name: CRUXVIEW
- Regulation Number: 21 CFR 872.1800 ●
- Regulation Name: Extraoral Source X-Ray System ●
- Regulatory Class: Class II ●
- Product Code: MUH
4. Predicate Device
- Manufacturer: Orion Corporation Soredex ●
- Trade/Device name: Digora for Windows 2.0 (K983267) ●
- Regulation number 21 CFR 872.1800 ●
- Regulation name: Extraoral Source X-Ray System ●
- Regulatory Class: Class II ●
- Classification Product Code: MUH ●
5. Description:
The CRUXVIEW is dental x-ray image management software which provides various
4
features to acquire, transfer, edit, display, and store scanned dental images which is specifically for a 510k cleared device (K183637), Cruxcan (CRX-1000). It also provides server/client model which allow users to upload and download the images and patient information from any workstations in the network environment.
CRUXVIEW consists of two parts: CRUXVIEW Viewer and CRUXVIEW Server. CRX-1000 sends the scanned image to the CRUXVIEW viewer. The CRUXVIEW viewer sends the received image to the CRUXVIEW Server. The CRUXVIEW Viewer searches the image stored in the CRUXVIEW Server and shows the image to the user. The subject device has various functions for users' needs including length and angle measurement functions. The CRUXVIEW supports DICOM file formats.
8. Indications for Use
The CRUXVIEW is a software intended for using and managing dental x-ray image sent by Cruxcan image plate scanner, storing the images and allowing the user to process and examine the images in order to achieve improved diagnoses.
9. Substantial Equivalence Discussion:
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | CRUXVIEW | DIGORA FOR WINDOWS 2.0 |
| 510k # | K211317 | K983267 |
| Manufacturer | CRUXELL Corp. | ORION CORPORATION SOREDEX |
| Indications for Use | The CRUXVIEW is a software intended to using and managing dental x-ray image sent by Cruxcan image plate scanner, storing the images and allowing the user to process and examine the images in order to achieve improved diagnoses. | The digora for windows is a software intended to using and managing dental x-ray image sent by digora image plate scanner, storing the images and allowing the user to process and examine the images in order to achieve improved diagnoses. The software can also support other imaging devices such as larger size imaging plate scanners and intraoral video cameras. |
| Network Protocol | TCP/IP | TCP/IP |
| Operating System | Windows 10 | Windows XP or higher |
| Monitor | ||
| (minimum | ||
| required) | 1280x1024 SXGA | 1024x768 True color XGA |
| RAM | 4GB or more | 1GB or more |
| Storage | 100GB or more | 100GB or more |
| Output Data | DICOM, BMP, JPEG, TIFF | DICOM, BMP, JPEG, TIFF |
| Backup | Yes | Yes |
| Dynamic range | 16bit | 16bit |
| DICOM | ||
| compatibility | DICOM 3.0 compliant | DICOM 3.0 compliant |
Comparison Chart
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| Image function | Pan, Rotate, Flip, Contrast/Histogram,
Invert, Zoom In/Out, Reset | Rotate, Flip, Contrast/Histogram, Invert,
Zoom In/Out, Reset, Color controller |
|------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Overlay function | Text, line, rectangle, circle | Text, line |
| Measurement | Distance, angle | Distance, angle |
12. Substantial Equivalence Discussion
CRUXVIEW is substantially equivalent to DIGORA FOR WINDOWS 2.0 (K983267) made by ORION CORPORATION SOREDEX in indications for use, technological characteristics including network protocol, operating system, and data format.
The difference between the two devices is whether to support color change of the original image. Even if the subject device does not support this feature, since this is an additional function just to suit the color preference of the user, this does not raise a question in substantial equivalence.
Based on the information we provided here in and the results of the performance test including SW validation, we concluded that the subject device is substantial equivalent to the predicate device.
13. Performance Tests
- · SW Validation for Viewer & Server
- · Performance test for accuracy of measurement function
The test results of the tests performed on the subject device supported that it is substantially equivalent to the predicate device.
The CRUXVIEW conforms with the following FDA-recognized standards.
- · ISO 15223-1 Medical devices Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
- · ISO 14971 Medical devices Application of risk management to medical devices
- · IEC 62304 Medical device software Software life cycle processes
- · IEC 62366-1 Medical devices Part 1: Application of usability engineering to medical devices
The followings are the FDA guidance documents utilized in the development of the subject device.
- · Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
· Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
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14. Conclusions:
Based on the information provided in this premarket notification, CRUXELL Corp. concludes that the CRUXVIEW is substantially equivalent to the predicate device as described herein in.