Who is the manufacturer of rainbow MCT?

Dentium Co., Ltd (Ict Branch) filed the 510(k) submission for rainbow MCT (K200270).

What is the FDA product code for rainbow MCT?

OAS. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for rainbow MCT?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like rainbow MCT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

rainbow MCT

Q: What are the predicate devices for rainbow MCT?

ProVecta 3D Prime with VistaSoft (K181432).

K200270 · Dentium Co., Ltd (Ict Branch) · OAS · Apr 16, 2021 · Radiology

Device Facts

Record ID	K200270
Device Name	rainbow MCT
Applicant	Dentium Co., Ltd (Ict Branch)
Product Code	OAS · Radiology
Decision Date	Apr 16, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	Pediatric

Indications for Use

rainbow MCT is a computed tomography x-ray system intended to produce 3D and panoramic diagnostic images of the maxillofacial areas for treatment planning for adult and pediatric patients. The device is operated and used by physicians, dentists, and x-ray technicians. Rainbow 3D Image Viewer software functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics.

Device Story

Cone beam CT X-ray system; generates sectional images of teeth, nasal cavity, and temporomandibular joint. X-ray source and detector rotate around patient; 2D images reconstructed into 3D volumetric view via mathematical algorithm. System components: X-ray generator, detector, collimator, main frame, rotation unit, PC, and monitor. Used in dental practices/clinics by physicians, dentists, and x-ray technicians. Rainbow 3D Image Viewer software manages acquisition, storage, display, and transmission of digital X-ray data. Output viewed on monitor for diagnostic and treatment planning purposes; assists clinicians in visualizing maxillofacial anatomy.

Clinical Evidence

Bench testing only. Performance evaluated per IEC 60601-1, IEC 60601-1-3, IEC 60601-2-63, IEC 60601-1-2, IEC 61223-3-4, and IEC 61223-3-5. Imaging performance (MTF, DQE, pixel resolution) compared against predicate and reference devices. No clinical data required.

Technological Characteristics

Computed tomography x-ray system; 60-100 kV tube voltage; 4-12 mA tube current; 0.5x0.5 mm focal spot; 2.5 mm Al filtration. Uses DTX3024 detector. Connectivity via DICOM 3.0. Software: Rainbow 3D ImageViewer. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for adult and pediatric patients requiring 3D and panoramic diagnostic imaging of the maxillofacial area for treatment planning.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

ProVecta 3D Prime with VistaSoft (K181432)

Reference Devices

PaX-Zenith3D (K102196)

Submission Summary (Full Text)

{0}------------------------------------------------ April 16, 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. Dentium Co., Ltd (ICT Branch) % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 7707 Fannin St. Ste 200, V111 HOUSTON TX 77054 Re: K200270 Trade/Device Name: rainbow MCT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: March 10, 2021 Received: March 15, 2021 Dear Mr. Kim: 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200270 Device Name rainbow MCT ### Indications for Use (Describe) rainbow MCT is a computed tomography x-ray system intended to produce 3D and panoramic diagnostic images of the maxillofacial areas for treatment planning for adult and pediatric patients. The device is operated and used by physicians, dentists, and x-ray technicians. Rainbow 3D Image Viewer software functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics. | Type of Use (Select one or both, as applicable) | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <table><tr><td> Prescription Use (Part 21 CFR 801 Subpart D) </td></tr><tr><td> Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | | 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 K200270 This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92. | 1. | Date Summary Prepared: | March 10,2021 | |----|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | 2. | Submitter's Identification: | | | | Submitter's Name : Submitter's Address: | Dentium Co., Ltd (ICT Branch) 76, Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16229 Republic of Korea | | | Submitter's Telephone: | ++82-70-7098-6932 | | | Contact person: | Mr. Sang Woo Lee (swlee1@dentium.com) | | | Official Correspondent: (U.S. Designated agent) | Dave Kim (davekim@mtech-inc.net) | | | Address: Telephone: | 7707 Fannin St. Ste 200, Houston, TX 77054 +1- 713-467-2607 | #### 3. Device: | Trade /Proprietary Name: | rainbow MCT | |--------------------------|-------------------------------------| | Device: | X-Ray, Tomography, Computed, Dental | | Regulation Description: | Computed tomography x-ray system. | | Review Panel: | Radiology | | Product Code: | OAS | | Regulation Number | 892.1750 | | Device Class | II | #### 4. Predicate Device: | Legally Marketed Predicate Device Information: | | |------------------------------------------------|-------------------------------------| | 510(k) Number: | K181432 | | Trade /Proprietary Name: | ProVecta 3D Prime with VistaSoft | | Device: | X-Ray, Tomography, Computed, Dental | | Regulation Description: | Computed tomography x-ray system. | | Review Panel | Radiology | | Product Code | OAS | | Regulation Number | 892.1750 | | Device Class | II | {4}------------------------------------------------ #### 5. Reference Device: Legally Marketed Predicate Device Information: | 510(k) Number: | K102196 | |---------------------------|----------------------------------| | Trade / Proprietary Name: | PaX-Zenith3D | | Regulation Description: | Computed tomography x-ray system | | Review Panel | Radiology | | Product Code | OAS | | Regulation Number | 892.1750 | | Device Class | II | #### 6. Device Description: - rainbow MCT is a cone beam CT X-ray device for generating sectional images of dental images such as tooth, nasal cavity and temporomandibular joint. this is a medical diagnostic equipment designed to generate sectional images by placing X-ray source opposite to the imaging detector unit and rotating it around a patient. 2D images of the region of interest are reconstructed using a mathematical algorithm in 3 dimensional volumetric view and displayed on the computer monitor. - The system is composed of X-ray generator, X-ray detector, X-ray collimator, main frame, rotation unit, PC and Monitor, etc. in compliance with US performance standard and regulatory requirement. #### 7. Indications for use: rainbow MCT is a computed tomography x-ray system intended to produce 3D and panoramic diagnostic images of the maxillofacial areas for treatment planning for adult and pediatric patients. The device is operated and used by physicians, dentists, and x-ray technicians. Rainbow 3D Image Viewer software features functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics. {5}------------------------------------------------ ### 8. Summary of the technological characteristics of the device compared to the predicate devices: | Descriptive Information | | Rainbow MCT K200270 | K181432, ProVecta 3D Prime with VistaSoft (DÜRR DENTAL) | |-----------------------------------------------------------------------------------------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | | - rainbow MCT is a computed tomography x-ray system intended to produce 3D and panoramic diagnostic images of the maxillofacial areas for treatment planning for adult and pediatric patients. The device is operated and used by physicians, dentists, and x-ray technicians. Rainbow 3D Image Viewer software features functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics. | ProVecta 3D Prime is computed tomography x-ray unit intended to generate 3D and panoramic X- ray images in dental radiography for adult and pediatric patients. It provides diagnostic details of the maxillofacial areas for a dental treatment. The device is operated and used by physicians, dentists, and x-ray technicians. Not intended for mammography use. The VistaSoft software features functions for recording, displaying, analyzing, diagnosing, managing and sending digital or digitized video and X-ray images in dental practices and specialist dental clinics. Not intended for mammography use | | Image Acquisition Modes | | Panoramic and computed tomography | Panoramic and computed tomography | | Input Voltage | | AC 100-240 V, 50/60 Hz | AC 200-240V | | Tube Voltage | | 60~100 kV | 50-99 KV | | Tube Current | | 4~12 mA | 4~16mA | | Focal Spot Size | | 0.5 x 0.5 mm | 0.5 mm | | Exposure Time | | Max. 19 s | Max. 16.4s | | Slice Width | | 0.1 mm min. | 0.1 mm min. | | Total Filtration | | 2.5 mm Al | 2.8 mm Al | | Chin Rest | | Bite block, chin rest and headrest | Bite block, chin rest and headrest | | Mechanical | | Compact design | Compact design | | Electrical | | LDCP logic circuit (Low Dark Current Processing) | LDCP logic circuit (Low Dark Current Processing) | | Software | | Rainbow 3D ImageViewer, DICOM 3.0 Format compatible | VistaSoft, DICOM 3.0 compatible | | Anatomical Sites | | Maxillofacial | Maxillofacial | | Image Receptor Note: CT and | Panoramic | DTX3024 | Xmaru1404CF | | | CBCT | DTX3024 | Xmaru1404CF | | panoramic image performance is identical because the sensors are identical. | MTF@ 1 lp/mm | 50% | 53% | | | DQE @ 0.5 lp/mm | 63% | 64% | | | | | | | Size of Imaging Volume (cm) | | DTX3024: Max. 10x8, 23x21 | Xmaru1404CF : Max. 10x8.5 | | Pixel Resolution | CBCT | DTX3024: 5 lp/mm | 2.5 lp/mm - 4x4 binning | | | Panoramic | DTX3024: 5 lp/mm | 2.5 lp/mm - 4x4 binning | | Pixel Size | CBCT | DTX3024 :100 μm | Xmaru1404CF : 99 μm - 2x2 binning 198 μm- 4x4 binning | | | Panoramic | DTX3024:100 μm | Xmaru1404CF : 99 μm - 2x2 binning 198 μm- 4x4 binning | # Summary of the Technological Characteristics {6}------------------------------------------------ {7}------------------------------------------------ #### 9. Rainbow MCT detectors VS. PaX-Zenith 3D Detectors | | | Rainbow MCT (K200270) | Pax-Zenith3D (K102196) | | | |--------------------------------------------------------|--------------------|------------------------------|--------------------------------|--------------------------------|-------------| | Imaging detector for CT and panoramic mode | CBCT | DTX3024 (10x8, 23 x 21cm) | Xmaru2430CF (FOV 24 x 19cm) | Xmaru1524CF (FOV 15 x 16cm) | | | | Panoramic | DTX3024 | | | Xmaru1501CF | | Imaging Performance | MTF@ 1 lp/mm | 50% | 53% | 52% | 50% | | | DQE @ 0.5 lp/mm | 63% | 64% | 45% | 60% | | Size of Imaging Volume (cm) | | | | | | | Pixel Resolution | CBCT | 5 lp/mm - 1x1 | 2.5 lp/mm - 4x4 binning | | | | | Panoramic | 5 lp/mm - 1x1 | | | 5 lp/mm | | Pixel Size | CBCT | 100 μm | 200 μm- | 200 μm- | | | | Panoramic | 100 μm | | | 100 μm | # 10. Discussion of Similarities and Differences: Rainbow MCT dental computed tomography X-ray system described in this 510(k) is similar to the predicate device in its indications for use, performance, materials, and safety characteristics. The differences include the digital X-ray imagers and image viewing software. The subject device offers FOV 10x8 & 23x21 cm whereas the predicate device and the reference device provide FOV 10.8.5 and 24x19 cm, respectively. Performance testing was conducted for the subject device to access whether or not the parameter required for functionalities related to imaging properties of the dental X-ray device meets the designated acceptance criteria. The MTF, DQE and pixel resolution of the subject device performed similar or better than those of the predicate and reference device. All test results were satisfactory. # 11. Non-Clinical Data and Performance Testing Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1(2005, AMD 1: 2012), IEC 60601-1-3 (2008 + A1: 2013), IEC 60601-2-63 (2012,041: 2017) )were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2 (2014). rainbow MCT meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set. {8}------------------------------------------------ Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed. Acceptance test according to IEC 61223-3-4 and IEC 61223-3-5 was performed. All test results were satisfactory. - 12. Clinical Data: Not required for a finding of substantial equivalence. # 13. Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate device in terms of technology, performance and indications for use, Dentium Co., Ltd concludes that the rainbow MCT is substantially equivalent to ProVecta 3D Prime with VistaSoft (K181432), the predicate device, and Pax-Zenith3D (K102196), the reference device as described herein. The differences between the new device and the predicate device shown in the comparison table above do not raise any new questions about safety and effectiveness and so we consider it substantially equivalent to the predicate device.

rainbow MCT

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

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Reference Devices

Submission Summary (Full Text)

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