(73 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the hardware and basic image acquisition methods.
No
The device is an imaging system intended for diagnostic support, not for treating conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support" and "for diagnostic support for adult and pediatric patients." It also mentions "growth and maturity assessment for orthodontic treatment," which is a diagnostic purpose.
No
The device description clearly outlines a hardware system including a C-arm, x-ray tube, and detector, which are physical components, not software.
Based on the provided information, the RCT800 device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- RCT800 Function: The RCT800 is an imaging system that uses X-rays to create images of internal structures (bones, teeth, etc.). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "radiographic examination" and "diagnostic support" based on these images.
- Device Description: The description focuses on the imaging technology (CBCT, panoramic, cephalometric) and how it captures images.
Therefore, the RCT800 falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
RCT800 is CBCT and panoramic x-ray imaging system with cephalometric.
Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option.
Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment.
The device is to be operated and used by dentists or other legally qualified heath care professionals.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
RCT800 is 3D computed tomography for scanning hard tissues like bone and teeth. By rotating the c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector on each end, CBCT images of dental maxillofacial is attained by recombining data from the same level that are scanned from different angle.
Panoramic image scanning function for attaining image of whole teeth, cephalometric scanning option for attaining cephalic image, and Model Scan option for attaining dental model CBCT image are included.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CBCT (Cone Beam Computed Tomography), Panoramic X-ray, Cephalometric X-ray
Anatomical Site
dento-maxillofacial, sinus, TMJ, Airway, wrist (carpus images)
Indicated Patient Age Range
adult and pediatric patients. We recommend patients for x-ray diagnostic radiation exposure to be over 5 years old.
Intended User / Care Setting
dentists or other legally qualified heath care professionals.
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
Clinical images were provided these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
For clinical testing, two licensed practitioners/clinicians observed and verified that dental X ray system from RCT800.
The clinical imaging samples are collected from the new detector on propose device at the 2 offices where the predicate device is installed on clinical consideration report for the clinical test images. These images were gathered from the new detector installed with RCT800 on any protocols with random patient age, gender, and size. As licensed practitioners or clinician diagnoses of the images, it might be proved that the clinical diagnosis and structures are acceptable in the region of interests.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The sponsor tested the subject device in a laboratory and provided a non-clinical performance report. The same test protocol was used to test the performance of the subject and the predicate device for comparison. The sponsor certifies that adequate design and development controls (according to 21 CFR 820.30) were in place for manufacturing the subject device.
Electrical, mechanical and environmental safety testing according to standard of IEC 60601-1: 2005/AMD1:2012(3.1 Edition), IEC 60601-1-3: 2008/AMD1:2013(Second Edition), IEC 60601-1-6:2010(Third Edition) and IEC 60601-2-63: 2012(first Edition) were performed. EMC testing was conducted in accordance with the standard IEC 60601-1-2: 2014(Edition 4.0).
Bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - Bench". Bench testing is used to assess whether or not the parameter measured required for describing functionalities related to imaging properties of the dental X-ray device and patient dosage satisfies the designated tolerance.
Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4 and IEC 61223-3-5. All test results were satisfactory.
Non-clinical considerations were conducted in accordance with FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices". RCT800 is equipped with FXDD-1012CHA. FXDD-1012CHA is a new SSXI detector, which is used to capture an image in panoramic, CBCT and Model Scan mode. Based on Non-Clinical Test results of FXDD-1012CHA for the subject device, is similar to that of the FXDD-0606CA for the Predicate device. All test results were satisfactory.
Clinical considerations were conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 20". For clinical testing, two licensed practitioners/clinicians observed and verified that dental X ray system from RCT800. The clinical imaging samples are collected from the new detector on propose device at the 2 offices where the predicate device is installed on clinical consideration report for the clinical test images. These images were gathered from the new detector installed with RCT800 on any protocols with random patient age, gender, and size. As licensed practitioners or clinician diagnoses of the images, it might be proved that the clinical diagnosis and structures are acceptable in the region of interests.
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.
Not Found
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
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the right side features the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 14, 2018
RAY Co., Ltd Changhwan Lee RA Manager 332-7, Samsung 1-ro Hwaseong-si, Gyeonggi-do 18380 KOREA
Re: K182805
Trade/Device Name: RCT800 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: September 27, 2018 Received: October 2, 2018
Dear Changhwan Lee:
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.
1
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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 medical devices and radiation-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,
Hsl 2. Nils
for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
4. Indications for Use Statement
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name RCT800
Indications for Use (Describe)
RCT800 is CBCT and panoramic x-ray imaging system with cephalometric.
Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option.
Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment.
The device is to be operated and used by dentists or other legally qualified heath care professionals.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
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4
5. 510(K) Summary
5
510(k) Summary
- K182805 1. 510(k) Summary
The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
-
- Date: September 27, 2018
3. Administrative Information
| APPLICANT | RAY Co.,Ltd |
|---|---|
| ADDRESS | #332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 18380, Korea |
| Manufacturer | RAY Co.,Ltd |
| 332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 18380, Korea | |
| TEL : +82-31-605-1000 | |
| FAX : +82-2-6280-5534 | |
| Contact Person | e-mail : ch0406.lee@raymedical.co.kr |
4. Device Information
Device Name
Trade/Proprietary Name: RCT800 Common Name: Dental panoramic/tomography and cephalometric x-ray system
Classification
Classification Name: Computed tomography x-ray system Regulation Number : 21 CFR 892.1750 Class : Il Product code : OAS Panel : Radiology
5. Predicate device
| Parameter | Predicate Device-1 |
|---|---|
| Device Name | RCT800 |
| Manufacturer | RAY Co., Ltd |
6
| 510(K) Number | K181452
Traditional 510k |
|----------------------|----------------------------------|
| Classification name | Computed tomography x-ray system |
| Regulation number | 892.1750 |
| Primary product code | OAS |
7. Device Description
System purpose RCT800 is 3D computed tomography for scanning hard tissues like bone and teeth. By rotating the c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector on each end, CBCT images of dental maxillofacial is attained by recombining data from the same level that are scanned from different angle.
Panoramic image scanning function for attaining image of whole teeth, cephalometric scanning option for attaining cephalic image, and Model Scan option for attaining dental model CBCT image are included.
8. Indication for use
RCT800 is CBCT and panoramic x-ray imaging system with cephalometric.
Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option. Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment.
The device is to be operated and used by dentists or other legally qualified heath care professionals.
9. Patient population
The patient population can be the possible person who can be taken X-ray diagnostic radiation exposure.
There is no restriction for ethnic group, Gender, weight, health, or condition.
We recommend patients for x-ray diagnostic radiation exposure to be over 5 years old.
10. Operating principle
The purpose of this unit is diagnose clinical structures of a tooth and head areas mainly by using the characteristics of permeability from X-ray. The principle of formations are as following. The machine is made of X-ray generator and arms in which transfers X-ray signals to a sensor in 2D. Also, an object that has a magnification is required in a distance. Moreover, the unit has to be adjustable depending on height of a patient and PC system to reconstruct an image.
The arm parts are controlled for rotating and linear moving to synchronize between the sensor and X-
7
ray generator to get the image of interests. The purpose of this mechanism is to provide the images in 2D or/and 3D as preferred to diagnose in a monitor. CBCT provides in 3D images as reconstructed and Panorama is to diagnose the structures in a panoramic view. Cephalometric allows for orthodontic treatment. These 3 functions could be in 1 system, Panorama with Cephalometric, or Panorama only system depending on the needs. To provide the features as mentioned above, digital transferring from permeated X-ray to absorbing to the sensor is essential and all the process are proceed in Detector. Detector transfers X-ray to light depending on the structure materials. Detector is separated into indirect method that the light is changed to digital signals on photodiode and direct method in which the light is directly transferred to digital signal. This unit is using both direct and indirect method depending on the interior structure materials.
8
11. Comparison with predicate device
The product is principally just the same as in the previous 510(k) #K181452. We added a CT/Pano detector to the predicate Device #K181452. And, CT protocol and FOV size have changed slightly due to the added detector.
The compared technical features for imaging technology, FOV, imaging parameters, resolution, and other basic characteristics are matching very closely, and the differences are so small that they do not have any effect on performance in practice. Both devices conform to given international performance standards.
| Parameter | Proposed Device | Predicate Device | |
|---|---|---|---|
| Manufacturer | RAY Co., Ltd. | RAY Co., Ltd. | |
| Device name | RCT800 | RCT800 | |
| 510(K) Number | (Special 510K) | K181452 | |
| (Traditional 510K) | |||
| Common Name | Dental panoramic/tomography and | ||
| cephalometric x-ray system | Dental panoramic/tomography and | ||
| cephalometric x-ray system | |||
| Indications | |||
| for use | Same as predicate device #1 | RCT800 is CBCT and panoramic x-ray | |
| imaging system with cephalometric. | |||
| Which is intended to radiographic | |||
| examination of the dento-maxillofacial, | |||
| sinus, TMJ, Airway for diagnostic | |||
| support for adult and pediatric patients. | |||
| And a model scan is included as an | |||
| option. | |||
| Cephalometric image is also includes | |||
| wrist to obtain carpus images for growth | |||
| and maturity assessment for orthodontic | |||
| treatment. | |||
| The device is to be operated and used | |||
| by dentists or other legally qualified | |||
| heath care professionals. | |||
| Mode of | |||
| Operation | Same as predicate device #1 | Continuous operation with | |
| intermittent, stated permissible | |||
| loading | |||
| 3D technology | Same as predicate device #1 | CBCT Cone beam | |
| Computed Tomography | |||
| Performance | |||
| Specification | Same as predicate device #1 | 1) CBCT Computed tomography |
- Patient
- Dental Model Scan(Optional)
- Panoramic
- Cephalometric(optional)
- One shot type
- Scan type | |
| Functional
Option | Same as predicate device #1 | Base
CT+PANO
Option(CEPH)
CT + PANO + SCAN CEPH
CT + PANO + One shot(One shot,
Standard Type)
CT + PANO + One shot(One shot,
Large Type) | |
| Detector
Type | CT | Same as predicate device #1 | FXDD-0606CA |
| | | FXDD-1012CHA | N/A |
| | PANO | Same as predicate device #1 | FXDD-0606CA |
| | | FXDD-1012CHA | N/A |
| | Ceph (Scan) | Same as predicate device #1 | XID-C24DC |
| | Ceph (One shot) | Same as predicate device #1 | 1717SCC |
| | | Same as predicate device #1 | PaxScan 2530C |
| Exposure switch
Type | | Same as predicate device #1 | "Deadman" Button type |
| | | Same as predicate device #1 | Ceph Apparatus |
| | | Same as predicate device #1 | Vertical Carriage |
| | | Same as predicate device #1 | Rotator |
| | | Same as predicate device #1 | X-RAY Generator |
| | | Same as predicate device #1 | X-ray tube |
| | | Same as predicate device #1 | High Frequency Generator |
| Main
Components | | Same as predicate device #1 | Column |
| | | Same as predicate device #1 | Touch monitor (panel) |
| | | Detector
- CT
FXDD-0606CA
FXDD-1012CHA | Detector - CT
FXDD-0606CA |
| | | - PANO
FXDD-0606CA
FXDD-1012CHA | - PANO
FXDD-0606CA |
| | | - Ceph
XID-C24DC(Scan)
1717SCC(One shot, Large Size)
PaxScan 2530C(One shot, Standard
Size) | - Ceph
XID-C24DC(Scan)
1717SCC(One shot, Large Size)
PaxScan 2530C(One shot, Standard
Size) |
| | | Same as predicate device #1 | Chinrest |
| | | Same as predicate device #1 | Head rest |
| | | Same as predicate device #1 | Automatic Collimator |
| | | Same as predicate device #1 | Exposure switch |
| | | Same as predicate device #1 | Emergency stop switch |
| | | Same as predicate device #1 | Console PC set |
| | | | |
| Automatic
Collimator | | Same as predicate device #1 | CT exams
Panoramic exams
Cephalometric exams |
| Display Type | Same as predicate device #1 | TFT LCD type(Normally black)
*1280x800 pixel | |
| Class | Same as predicate device #1 | Class I with type B applied parts
according to IEC 60601-1 | |
| Focal size | Same as predicate device #1 | Patient 0.5
Model scan 0.04 (Optional) | |
| Field of
View(CT) | FXDD-0606CA : Max.160x100 mm
FXDD-1012CHA : Max. 200x200 mm | FXDD-0606CA : Max.160x100 mm | |
| X-ray Voltage(Patient) | Same as predicate device #1 | 6090kVp | |17mA | |
| X-ray Current(Patient) | Same as predicate device #1 | 4
| X-ray Voltage(Model Scan,
Optional) | Same as predicate device #1 | 5080kVp | |0.7mA | |
| X-ray Current(Model Scan,
Optional) | Same as predicate device #1 | 0.4
| Total Filtration | Same as predicate device #1 | Min. 2.8 mm Al equivalent | |
| Detector
Pixel size | CT | Same as predicate device #1 | FXDD-0606CA: 119µm |
| | FXDD-1012CHA: 124µm | N/A | |
| | PANO | Same as predicate device #1 | FXDD-0606CA: 119µm |
| | FXDD-1012CHA: 124µm | N/A | |
| | Ceph (Scan) | Same as predicate device #1 | XID-C24DC: 100µm |
| | Ceph(One shot) | Same as predicate device #1 | 1717SCC: 127µm |
| | | Same as predicate device #1 | PaxScan 2530C: 139µm |
| Magnifica
tion | CT | Same as predicate device #1 | FXDD-0606CA: 1.44(Patient)
1.91(Model Scan) |
| | FXDD-1012CHA: 1.44(Patient)
1.91(Model Scan) | N/A | |
| | PANO | Same as predicate device #1 | FXDD-0606CA: 1.3 |
| | FXDD-1012CHA: 1.3 | N/A | |
| | Ceph (Scan) | Same as predicate device #1 | XID-C24DC: 1.11 |
| | Ceph(One shot) | Same as predicate device #1 | 1717SCC: 1.13 |
| | | Same as predicate device #1 | PaxScan 2530C: 1.12 |
| Scan time | | Same as predicate device #1 | CT : below 14sec(Patient)
CT : below 180sec(Model Scan) |
| | Same as predicate device #1 | Pano : below 14sec | |
| | Same as predicate device #1 | Ceph[Scan type] : below 19sec | |
| | Same as predicate device #1 | Ceph[One shot type]:
below 2sec | |
| Format compatible | | Same as predicate device #1 | DICOM 3.0 Format compatible |
| Image Viewing Software | | Same as predicate device #1 | RayScan
(Cleared under K181452) |
| Image acquisition | | Same as predicate device #1 | Giga-Ethernet Network |
| Total Height | | Same as predicate device #1 | Max 2.296mm |
| Weight | Same as predicate device #1 | 1) Computed Tomography(CT) +
Panoramic(PANO)=189kg(416.6lb) ±
10%
- Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(Scan type)= 219kg (482.8lb) ± 10% - Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type, installed in Standard
size)= 217kg (478.4lb) ± 10% - Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type, installed in Large size)
212kg (467.3lb) ± 10% | |
| Type of
installation | Same as predicate device #1 | Wall or floor mount | |
| Patient position | Same as predicate device #1 | Standing / Wheelchair | |
| Applicable
Standards | Same as predicate device #1 | IEC 60601-1
IEC 60601-1-3
IEC 60601-2-63
IEC 60601-1-2 | |
9
10
11
12
12. Safety and Effectiveness Information
RCT800 system described in this 510(k) is similar to the predicate device in terms of indications for use, materials, safety characteristics, and X-ray source.
The following information further substantial equivalence between the subject device and predicate device.
The fundamental technological characteristics of the subject and predicate device are similar.
The imaging modes are similar; PANO, CEPH (Optional), CBCT, Model Scan All viewing software programs have been cleared with previous 510k submissions; RAYSCAN(K181452).
The sponsor tested the subject device in a laboratory and provided a non-clinical performance report. The same test protocol was used to test the performance of the subject and the predicate device for comparison. The sponsor certifies that adequate design and development controls (according to 21 CFR 820.30) were in place for manufacturing the subject device.
The differences are as follows.
- The subject device is equipped with new CT/PANO detectors, FXDD-1012CHA.
Electrical, mechanical and environmental safety testing according to standard of IEC 60601-1: 2005/AMD1:2012(3.1 Edition), IEC 60601-1-3: 2008/AMD1:2013(Second Edition), IEC 60601-1-6:2010(Third Edition) and IEC 60601-2-63: 2012(first Edition) were performed. EMC testing was conducted in accordance with the standard IEC 60601-1-2: 2014(Edition 4.0).
The software of RCT800 saves the patient and image data and offers an inquiry function, in addition, supports the image generate function intended to obtain images using the RCT800 equipment and various sensors for diagnosis. And that has been validated according to FDA "Guidance for the Content d Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" to assure substantial equivalence. The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator. As a result, we identified the level of concern associated with new device and provided documentation consistent with that level. Based on our risk analysis of software, the difference does not affect its safety and effectiveness.
Bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - Bench"
Bench testing is used to assess whether or not the parameter measured required for describing functionalities related to imaging properties of the dental X-ray device and patient dosage satisfies the designated tolerance.
Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4 and IEC 61223-3-5.
All test results were satisfactory.
Non-clinical considerations were conducted in accordance with FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices".
RCT800 is equipped with FXDD-1012CHA. FXDD-1012CHA is a new SSXI detector, which is used to capture an image in panoramic, CBCT and Model Scan mode.
Based on Non-Clinical Test results of FXDD-1012CHA for the subject device, is similar to that of the FXDD-0606CA for the Predicate device.
All test results were satisfactory.
Clinical considerations were conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 20".
13
Clinical images were provided these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
For clinical testing, two licensed practitioners/clinicians observed and verified that dental X ray system from RCT800.
The clinical imaging samples are collected from the new detector on propose device at the 2 offices where the predicate device is installed on clinical consideration report for the clinical test images. These images were gathered from the new detector installed with RCT800 on any protocols with random patient age, gender, and size. As licensed practitioners or clinician diagnoses of the images, it might be proved that the clinical diagnosis and structures are acceptable in the region of interests.
12. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. RAY Co., Ltd. concludes that the newly RCT800 is safe and effective and substantially equivalent to predicate device as described herein.