(48 days)
No
The summary describes standard digital radiography technology and image processing without mentioning AI or ML.
No.
The device is used for capturing, digitizing, and processing intra-oral x-ray images; it does not explicitly state that it treats any disease or condition.
No
The device is indicated for capturing, digitizing, and processing intra-oral x-ray images, meaning it is an image acquisition and processing system. It does not perform a diagnostic function itself, but rather provides the images for a qualified staff to diagnose.
No
The device description explicitly states it consists of a scanner, reusable imaging plates, and workstation software, indicating it includes hardware components in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "capturing, digitization and processing of intra-oral x-ray images stored in imaging plate recording media." This describes a system for acquiring and processing medical images, not for performing tests on biological samples.
- Device Description: The description details a dental computed radiography system that scans X-ray exposed imaging plates to produce digital X-ray images. This is consistent with medical imaging equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device's function is solely related to the acquisition and processing of medical images.
N/A
Intended Use / Indications for Use
The CRUXCAN (CRX-1000) is indicated for capturing, digitization and processing of intra-oral x-ray images stored in imaging plate recording media.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
The CRUXCAN (CRX-1000) is a dental computed radiography system and is intended to produce digital X-Ray images for dental radiography purposes. It consists of a scanner, reusable imaging plates and workstation software. This device scans X-Ray exposed imaging plate and produces X-Ray image in digital form. Then, digital image is transferred to workstation for further processing and routing.
The design features a built-in erase function and a color touch-screen LCD panel without physical push buttons for device operation. This device is intended to be operated in a radiological environment by qualified staff.
The Imaging Plate is a polyester film made of densely applied particles of inorganic crystals called photostimulable phosphor. It is a flexible X-ray sensor for the CR system which can be used with a conventional medical X-ray imaging system and can be employed as a substitute for the screen/film system. The phosphor layer has a function of recording an X-ray image. This photostimulable phosphor is a special luminescent material which stores X-ray energy and emits light proportional to the stored X-ray energy when stimulation energy such as visible light is irradiated onto it.
CRUXCAN TWAIN Driver and Viewer which transmit and display images are substantially equivalent to the predicate device software as well in terms of functions and principle of operations. The User interface is slightly different but the differences in design do not raise questions in device effectiveness.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Intra-oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiological environment by qualified staff.
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)
Performance studies were conducted on the device imaging plate according to the FDA guidance "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices".
The CRUXCAN (CRX-1000) has been tested for Electromagnetic Compatibility and Safety in accordance with the IEC60601 standards. The devices operated within the EMI emission, susceptibility and static discharge levels specified in the IEC 60601 standards.
Software Validation Test
The test results of the tests performed on the subject device supported that it is substantially equivalent to the predicate device.
Clinical testing was not necessary for the subject device, in order to demonstrate substantial equivalence.
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.
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 12, 2019
CRUXELL Corp. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 IRVINE CA 92620
Re: K183637
Trade/Device Name: CRUXCAN (CRX-1000) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: December 10, 2018 Received: December 26, 2018
Dear Ms. 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
1
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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
CRUXCAN (CRX-1000)
Indications for Use (Describe)
The CRUXCAN (CRX-1000) is indicated for capturing, digitization and processing of intra-oral x-ray images stored in imaging plate recording media.
| 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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3
510(k) Summary
(K183637)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Feb 5, 2019
1. 510K Applicant / Submitter:
CRUXELL Corp. A-405, Migun Techno World II, 187 techno 2-ro. Yuseong-gu. Daejeon, 34025 South 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
- . Proprietary Name: CRUXCAN (CRX-1000)
- Common Name: Dental PSP Scanner ●
- Classification: Class II (21 CFR 872.1800) ●
- Product Code: MUH .
- Regulation Name: Extraoral source x-ray system .
4. Predicate Devices
- 4.1. Digora Optime (K041050) by Soredex Instrumentariumn Corporation
- Common Name: Dental PSP Scanner .
- Classification: Class II (21 CFR 872.1800) .
- Product Code: MUH
- Regulation Name: Extraoral source x-ray system .
4
4.2. Digora Optime (K133231) by Instrunmentariuin Dental
- . Common Name: Dental PSP Scanner
- Classification: Class II (21 CFR 872.1800) .
- . Product Code: MUH
- Regulation Name: Extraoral source x-ray system .
5. Device Description:
The CRUXCAN (CRX-1000) is a dental computed radiography system and is intended to produce digital X-Ray images for dental radiography purposes. It consists of a scanner, reusable imaging plates and workstation software. This device scans X-Ray exposed imaging plate and produces X-Ray image in digital form. Then, digital image is transferred to workstation for further processing and routing.
The design features a built-in erase function and a color touch-screen LCD panel without physical push buttons for device operation. This device is intended to be operated in a radiological environment by qualified staff.
The Imaging Plate is a polyester film made of densely applied particles of inorganic crystals called photostimulable phosphor. It is a flexible X-ray sensor for the CR system which can be used with a conventional medical X-ray imaging system and can be employed as a substitute for the screen/film system. The phosphor layer has a function of recording an X-ray image. This photostimulable phosphor is a special luminescent material which stores X-ray energy and emits light proportional to the stored X-ray energy when stimulation energy such as visible light is irradiated onto it.
CRUXCAN TWAIN Driver and Viewer which transmit and display images are substantially equivalent to the predicate device software as well in terms of functions and principle of operations. The User interface is slightly different but the differences in design do not raise questions in device effectiveness.
8. Indications for Use
The CRUXCAN (CRX-1000) is indicated for capturing, digitization and processing of intraoral x-ray images stored in imaging plate recording media.
5
9. Substantial Equivalence Discussion:
| Subject Device | Predicate Device | Reference Device | SE Note | |
|---|---|---|---|---|
| 510k # | K183637 | K041050 | K133231 | |
| Device Name | CRUXCAN | Digora Optime | Digora Optime | |
| Manufacturer | CRUXELL Co., Ltd. | Soredex Instrumentariumn | ||
| Corporation | Instrunmentariuin | |||
| Dental | ||||
| Indications for Use | The CRUXCAN (CRX-1000) is indicated for | |||
| capturing, digitization | ||||
| and processing of intra-oral x-ray images stored | ||||
| in imaging plate | ||||
| recording media. | The Digora Optime | |||
| imaging system is indicated | ||||
| for capturing, digitization | ||||
| and processing of intra oral | ||||
| x-ray images stored in | ||||
| imaging plate recording | ||||
| media. | The DIGORA0 | |||
| Optime imaging | ||||
| system is indicated for | ||||
| capturing, digitization | ||||
| and processing of | ||||
| intra oral x-ray images | ||||
| stored in imaging | ||||
| plate recording media. | Equivalent | |||
| Communication | TIFF / Raw Format | DICOM | DICOM | No issue on |
| safety and | ||||
| effectiveness | ||||
| Power Supply | 50 – 60 Hz | |||
| 100 - 240 V ~ | 50 – 60 Hz | |||
| 100 - 240 V ~ | 50 – 60 Hz | |||
| 100 - 240 V ~ | Equivalent | |||
| Operating System | Windows 10 or higher | Windows NT 4.0/2000/XP | Windows 7 or 8 | Equivalent |
| X-ray Absorber | Imaging Plate | Imaging Plate | Imaging Plate | Equivalent |
| Cassette Size | Size 0 : 22 x 31mm | |||
| Size 1 : 24 x 40mm | ||||
| Size 2 : 31 x 41mm | ||||
| Size 3 : 27 x 54mm | Size 0 : 22 x 31mm | |||
| Size 1 : 24 x 40mm | ||||
| Size 2 : 31 x 41mm | ||||
| Size 3 : 27 x 54mm | Size 0 : 22 x 31mm | |||
| Size 1 : 24 x 40mm | ||||
| Size 2 : 31 x 41mm | ||||
| Size 3 : 27 x 54mm | No issue on | |||
| safety and | ||||
| effectiveness | ||||
| Pixel Size | 25 um | |||
| 50 um | 40 um | |||
| 64 um | 30um | |||
| 60um | No issue on | |||
| safety and | ||||
| effectiveness | ||||
| Dynamic Range | ||||
| (Acquisition) | 8bit /16 bit | 14 bit | 14 bit | Equivalent |
| Resolution | 14.0lp/mm @ 25um | 12.5 lp/mm @ 40um | 16.7 lp/mm@30um | No issue on |
| safety and | ||||
| effectiveness | ||||
| Imaging Plate | ||||
| Performance |
- DQE
- MTF
- Max. Resolution | DQE at 10% efficiency:
2.8 lp/mm
MTF at 3lp/mm : 35%
Max resolution : 25um | DQE at 10% eff : 2.4
lp/mm
MTF at 3lp/mm : 32%
Max resolution : 40um | DQE at 10% eff : 2.4
lp/mm
MTF at 3lp/mm : 32%
Max resolution : 30um | No issue on
safety and
effectiveness |
The CRUXCAN is substantially equivalent to the predicate device, Digora Optime (K041050) and Digora Optime (K133231) in indications for use, imaging principle, and physical characteristics. The CRUXCAN also has similarities in power supply, operating system, X-ray absorber and imaging plate size.
The differences of the three devices are pixel size, dynamic range, resolution, and image plate performance. As compared in the chart above, the subject device has better or substantially equivalent resolution, DQE, and MTF data. The smaller pixel size of subject device than
6
the predicate device offers wider dynamic range with storing image data using more bits.
The imaging plates are similar to the predicate plates and they employ the same technology and principle of operation. Despite the minor differences, the results of the performance testing provided in the submission support that the subject device is substantially equivalent to the predicate device.
10. Performance Tests
- . Performance studies were conducted on the device imaging plate according to the FDA guidance "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices".
- . The CRUXCAN (CRX-1000) has been tested for Electromagnetic Compatibility and Safety in accordance with the IEC60601 standards. The devices operated within the EMI emission, susceptibility and static discharge levels specified in the IEC 60601 standards.
- . Software Validation Test
The test results of the tests performed on the subject device supported that it is substantially equivalent to the predicate device.
Clinical testing was not necessary for the subject device, in order to demonstrate substantial equivalence.
11. Conclusions:
Based on the information provided in this premarket notification, CRUXELL Corp. concludes that the CRUXCAN (CRX-1000) is substantially equivalent to the predicate device as described herein in.