(437 days)
No
The description focuses on standard CT reconstruction algorithms and does not mention AI or ML.
No
The device is described as a diagnostic imaging system, not a therapeutic one. Its core function is to produce images for diagnosis and treatment planning, not to treat a condition.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "intended to produce 3D and panoramic diagnostic images of the maxillofacial areas for treatment planning" and the 'Device Description' refers to it as "medical diagnostic equipment."
No
The device description explicitly lists hardware components such as "X-ray generator, X-ray detector, X-ray collimator, main frame, rotation unit, PC and Monitor, etc." and describes it as a "cone beam CT X-ray device".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This process happens outside of the body ("in vitro").
- Device Function: The rainbow MCT is an X-ray system that produces images of the maxillofacial areas within the patient's body. It uses radiation to create images, not to analyze biological samples.
- Intended Use: The intended use is for producing diagnostic images for treatment planning, which is a function of medical imaging devices, not IVDs.
- Device Description: The description details the components of an X-ray imaging system, not a device for analyzing biological specimens.
Therefore, the rainbow MCT falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
OAS
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.
Mentions image processing
2D images of the region of interest are reconstructed using a mathematical algorithm in 3 dimensional volumetric view and displayed on the computer monitor.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Computed Tomography X-ray
Anatomical Site
maxillofacial areas
Indicated Patient Age Range
adult and pediatric patients.
Intended User / Care Setting
physicians, dentists, and x-ray technicians. The device is operated and used by physicians, dentists, and x-ray technicians.
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 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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MTF@ 1 lp/mm: 50%
DQE @ 0.5 lp/mm: 63%
Pixel Resolution (CBCT): 5 lp/mm - 1x1
Pixel Resolution (Panoramic): 5 lp/mm - 1x1
Pixel Size (CBCT): 100 μm
Pixel Size (Panoramic): 100 μm
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
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) | ||
|---|---|---|
| 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) |
| 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 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 | | 60100 kV | 50-99 KV |12 mA | 4~16mA |
| Tube Current | | 4
| 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.
-
- 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.