(30 days)
No
The summary describes a standard dental X-ray imaging system (Panoramic, Cephalometric, CBCT) and its technical specifications. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, performance studies, or other sections. The focus is on image acquisition and reconstruction using traditional methods.
No.
The device is an imaging system used for diagnosis, not for therapy.
Yes
The device is described as an "extra-oral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures." It is used to generate 3D images and for various studies (panoramic, implantology, TMJ, cephalometry), all of which are diagnostic activities.
No
The device description explicitly states it is an "extra-oral source x-ray system" and describes hardware components like a "C-arm, which houses a high-voltage generator, a X-ray tube and a detector". This indicates it is a hardware device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The RAYSCAN a-Expert3D is an extra-oral source x-ray system. It uses X-rays to create images of the teeth, jaw, and oral structures within the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "dental radiographic examination" and generating "dentomaxillofacial 3D images." This is an imaging device, not a diagnostic test performed on a sample.
Therefore, based on the provided information, the RAYSCAN a-Expert3D is a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
RAYSCAN a-Expert3D, panoramic x-ray imaging system with cephalostat, is an extra-oral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBCT technique, to generate dento-maxillo-facial 3D images.
The device uses cone shaped x-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations.
Product codes
OAS
Device Description
System purpose RAYSCAN alpha-3D, SM3D, M3DS and M3DL are 3D computed tomography for scanning hard tissues like bone and teeth. By rotating the C-arm, which houses a high-voltage generator, a X-ray tube and a detector on each end, CBCT images of dental maxillofacial structures are obtained by recombining data scanned from the same level at different angles. Functionalities include panoramic image option and cephalometric option.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray (Cone Beam Computed Tomography, Panoramic, Cephalometric)
Anatomical Site
teeth, jaw, and oral structures, dento-maxillo-facial, TMJ, sinus, Airway, wrist (for carpus images)
Indicated Patient Age Range
The device is intended to acquire diagnostic x-ray images of adult and pediatric individuals/patients without restriction on ethnic group, gender, weight, health status, or condition.
We recommend that patients who undergo X-ray diagnostic radiation exposure be over 5 years old.
Intended User / Care Setting
Not Found. The reference device RCT800 states, "The device is to be operated and used by dentists or other legally qualified health 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, and while these images were not necessary to establish substantial equivalence based on the modifications to the device, they provide further evidence, in addition to the laboratory performance data, to show that the complete system works as intended.
The features of RAYSCAN a-Expert3D were clinically tested and approved by two licensed practitioners/clinicians. Clinical imaging samples were collected from new detectors on the proposed device at the two offices where the predicate device was installed for the clinical test images. These images were gathered from all detectors installed with RAYSCAN a-Expert3D using protocols with random patient age, gender, and size. A licensed practitioner reviewed the sample clinical images and deemed them to be of acceptable quality for the intended use.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted according to the FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices". Bench testing is used to assess whether the parameters required to describe functionalities related to imaging properties of the dental X-ray device and patient dosage satisfy the designated tolerance.
Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4 and IEC 61223-3-7. All test results were satisfactory.
Non-clinical considerations were conducted in accordance with the FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices."
Because the subject device uses the same detector as the predicate device, there are no significant differences between the two devices as a result of non-clinical testing.
Clinical considerations were conducted according to the FDA Guidance "Format for Traditional and Abbreviated 510(k)s". Clinical images were provided, and while these images were not necessary to establish substantial equivalence based on the modifications to the device, they provide further evidence, in addition to the laboratory performance data, to show that the complete system works as intended.
The features of RAYSCAN a-Expert3D were clinically tested and approved by two licensed practitioners/clinicians. Clinical imaging samples were collected from new detectors on the proposed device at the two offices where the predicate device was installed for the clinical test images. These images were gathered from all detectors installed with RAYSCAN a-Expert3D using protocols with random patient age, gender, and size. A licensed practitioner reviewed the sample clinical images and deemed them to be of acceptable quality for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
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 text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
August 31, 2023
Ray Co., Ltd. % Sooji Huh RA Specialist 1F~3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu Yongin-si, Gyeonggi-do 16882 SOUTH KOREA
Re: K232287
Trade/Device Name: RAYSCAN a-Expert3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: August 1, 2023 Received: August 1, 2023
Dear Sooji Huh:
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/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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
4. Indications for Use Statement
3
Indications for Use
510(k) Number (if known)
Device Name
RAYSCAN a-Expert3D
Indications for Use (Describe)
RAYSCAN a-Expert3D, panoramic x-ray imaging system with cephalostat, is an extra-oral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBCT technique, to generate dentomaxillofacial 3D images.
The device uses cone shaped x-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations.
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Type of Use (Select one or both, as applicable)
4
510(k) Summary
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.
2. Date: Aug 01, 2023
3. Administrative Information
| Applicant | Ray Co., Ltd. | |
|---|---|---|
| Address | 1F~3F, 4F(Part), 5F, 265, Daeji-ro, Suji-gu, Yongin-si, | |
| 16882, Korea | ||
| Manufacturer | Name | Ray Co., Ltd. |
| Address | 1F~3F, 4F(Part), 5F, 265, Daeji-ro, Suji-gu, Yongin-si, | |
| 16882, Korea | ||
| Tel | +82-31-605-1000 | |
| Fax | +82-2-6280-5534 | |
| Contact Person | Name | Sooji Huh |
| Sooji.huh@raymedical.co.kr |
4. Device Information
| Trade/Proprietary Name | RAYSCAN α-Expert3D | |
|---|---|---|
| Common Name | Dental Panoramic/Tomography and Cephalometric X-ray | |
| System | ||
| Classification | ||
| Name | Device | Computed tomography x-ray system |
| Regulation | ||
| Number | 21 CFR 892.1750 | |
| Class | 2 | |
| Product Code | OAS | |
| Review Panel | Radiology |
5
| Parameter | Predicate Device | Reference Device |
|---|---|---|
| Device Name | RAYSCAN α-Expert3D | RCT800 |
| Manufacturer | RAY Co., Ltd | RAY Co., Ltd |
| 510(K) Number | K190812 | |
| Special 510k | K230753 | |
| Special 510k | ||
| Classification name | Computed tomography x-ray | |
| system | Computed tomography x-ray | |
| system | ||
| Regulation number | 892.1750 | 892.1750 |
| Primary product code | OAS | OAS |
5. Predicate device
6. Device Description
System purpose RAYSCAN α-3D, SM3D, M3DS and M3DL are 3D computed tomography for scanning hard tissues like bone and teeth. By rotating the C-arm, which houses a high-voltage generator, a X-ray tube and a detector on each end, CBCT images of dental maxillofacial structures are obtained by recombining data scanned from the same level at different angles. Functionalities include panoramic image option and cephalometric option.
7. Indication for use
RAYSCAN α-Expert3D, panoramic x-ray imaging system with cephalostat, is an extra-oral source xray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for anoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBCT technique, to generate dento-maxillo-facial 3D images.
The device uses cone shaped x-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations.
8. Patient population
The device is intended to acquire diagnostic x-ray images of adult and pediatric individuals/patients without restriction on ethnic group, gender, weight, health status, or condition.
We recommend that patients who underqo X-ray diagnostic radiation exposure be over 5 years old.
6
9. Comparison with predicate device
| The following table provides the summary of the technological characteristics of RAYSCAN a-Expert3D compared to the predicate device | ||
|---|---|---|
| Parameter | Proposed Device | Predicate Device | Reference Device | |
|---|---|---|---|---|
| Manufacturer | RAY Co., Ltd. | RAY Co., Ltd. | RAY CO., Ltd. | |
| Device name | RAYSCAN α-Expert3D | RAYSCAN α-Expert3D | RCT800 | |
| 510(K) Number | (Special 510K) | K190812 | ||
| (Special 510K) | K230753 | |||
| (Special 510K) | ||||
| Common | ||||
| Name | Dental panoramic/tomography and | |||
| cephalometric x-ray system | Dental panoramic/tomography and | |||
| cephalometric x-ray system | Dental panoramic/tomography and | |||
| cephalometric x-ray system | ||||
| Indications | ||||
| for use | Same as predicate device #1 | RAYSCAN α-Expert 3D, panoramic x- | ||
| ray imaging system with cephalostat, is | ||||
| an extraoral source x-ray system, which | ||||
| is intended for dental radiographic | ||||
| examination of the teeth, jaw, and oral | ||||
| structures, specifically for panoramic | ||||
| examinations and implantology and for | ||||
| TMJ studies and cephalometry, and it | ||||
| has the capability, using the CBCT | ||||
| technique, to generate dento-maxillo- | ||||
| facial 3D images. The device uses cone | ||||
| shaped x-ray beam projected on to a | ||||
| flat panel detector, and the examined | ||||
| volume image is reconstructed to be | ||||
| viewed in 3D viewing stations. | 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 | ||||
| health care professionals. | ||||
| Mode of | ||||
| Operation | Same as predicate device #1 | Continuous operation with | ||
| intermittent, stated permissible | ||||
| loading | Same as predicate device #1 | |||
| 3D technology | Same as predicate device #1 | CBCT Cone beam | ||
| Computed Tomography | Same as predicate device #1 | |||
| Performance | ||||
| Specification | Same as predicate device #1 | 1) CBCT Computed tomography |
- Panoramic
- Cephalometric(optional)
- One shot type
- Scan type | 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
RAYSCAN α-3D :
CT+PANO
Option(CEPH)
RAYSCAN α-SM3D:
CT + PANO + SCAN CEPH
RAYSCAN α-M3DS:
CT + PANO + One shot(One shot,
Standard Type)
RAYSCAN α-M3DL:
CT + PANO + One shot(One shot,
Large Type) | 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 | N/A | C10900D | FXDD-1724R |
| | | Same as predicate device #1 | FXDD-0606CA | FXDD-1012CHA |
| Detector
Type | PANO | Same as predicate device #1 | FXDD-0606CA | FXDD-1724R |
| | | N/A | C10500D | FXDD-1012CHA |
| Detector
Type | Ceph (Scan) | Same as predicate device #1 | XID-C24DC | Same as predicate device #1 |
| Detector
Type | Ceph (One shot) | Same as predicate device #2 | PaxScan 4336X | FXRD-1717VA |
| Detector
Type | | N/A | 1717SCC | N/A |
| Detector
Type | | Same as predicate device #2 | PaxScan 2530C | FXDD-1012CA |
| Exposure switch
Type | | Same as predicate device #1 | "Deadman" Button type | Same as predicate device #1 |
| | | | | |
| | Same as predicate device #1 | Ceph Apparatus | Same as predicate device #1 | |
| | Same as predicate device #1 | Vertical Carriage | Same as predicate device #1 | |
| | Same as predicate device #1 | Rotator | Same as predicate device #1 | |
| | Same as predicate device #1 | X-RAY Generator | Same as predicate device #1 | |
| | Same as predicate device #1 | X-ray tube | Same as predicate device #1 | |
| | Same as predicate device #1 | High Frequency Generator | Same as predicate device #1 | |
| | Same as predicate device #1 | Column | Same as predicate device #1 | |
| | Same as predicate device #1 | Touch monitor (panel) | Same as predicate device #1 | |
| Main
Components | Detector -
CT
FXDD-0606CA -
PANO
FXDD-0606CA -
Ceph
XID-C24DC(Scan)
FXRD-1717VA (One shot, Large Size)
FXDD-1012CA (One shot, Standard
Size) | Detector -
CT
C10900D
FXDD-0606CA -
PANO
C10500D
FXDD-0606CA -
Ceph
XID-C24DC(Scan)
PaxScan 4336X(One shot, Large Size)
1717SCC(One shot, Large Size)
PaxScan 2530C(One shot, Standard
Size) | Detector -
CT
FXDD-1724RA
FXDD-1012CHA -
PANO
FXDD-1724RA
FXDD-1012CHA -
Ceph
XID-C24DC(Scan)
FXRD-1717VA(One shot, Large Size)
FXDD-1012CA(One shot, Standard
Size) | |
| | Same as predicate device #1 | Chinrest | Chinrest | |
| | Same as predicate device #1 | Head rest | Head rest | |
| | Same as predicate device #1 | Automatic Collimator | Unknown | |
| | Same as predicate device #1 | Exposure switch | Exposure switch | |
| | Same as predicate device #1 | Emergency stop switch | Emergency stop switch | |
| | Same as predicate device #1 | Console PC set | Console PC set | |
| Automatic
Collimator | | Same as predicate device #1 | CT exams
Panoramic exams
Cephalometric exams | Same as predicate device #1 |
| Display Type | | Same as predicate device #1 | TFT LCD type(Normally black)
*1280x800 pixel | Same as predicate device #1 |
| Class | | Same as predicate device #1 | Class I with type B applied parts
according to IEC 60601-1 | Same as predicate device #1 |
| Focal size | | Same as predicate device #1 | 0.5 | Same as predicate device #1 |
| Field of
View(CT) | | Same as predicate device #1 | Max.100x100 mm | FXDD-1724RA : Max.180x160 mm
FXDD-1012CHA : Max.200x200 mm |
| X-ray Voltage(Patient) | | Same as predicate device #2 | 6090kVp | 60100kVp |
| X-ray Current(Patient) | | Same as predicate device #2 | 417mA | 117mA |
| Total Filtration | | Same as predicate device #1 | Min. 2.8 mm Al equivalent | Same as predicate device #1 |
| Detector
Pixel size | CT | N/A | C10900D: 200μm | FXDD-1724R : 95μm |
| | CT | Same as predicate device #1 | FXDD-0606CA: 119μm | FXDD-1012CHA : 124μm |
| | PANO | Same as predicate device #1 | FXDD-0606CA: 119μm | FXDD-1724R : 95μm |
| | PANO | N/A | C10500D: 100μm | FXDD-1012CHA : 124μm |
| | Ceph (Scan) | Same as predicate device #1 | XID-C24DC: 100μm | Same as predicate device #1 |
| | Ceph(One shot) | Same as predicate device #2 | PaxScan 4336X: 139μm | FXRD-1717VA : 140μm |
| | Ceph(One shot) | N/A | 1717SCC: 127μm | N/A |
| Magnifica
tion | CT | Same as predicate device #2 | PaxScan 2530C: 139μm | FXDD-1012CA : 124μm |
| | CT | Same as predicate device #2 | C10900D:1.39
FXDD-0606CA: 1.44 | 1.44 |
| | PANO | 1.35 | C10500D: 1.3
FXDD-0606CA: 1.3 | 1.31 |
| | Ceph (Scan) | Same as predicate device #1 | XID-C24DC: 1.11 | Same as predicate device #1 |
| | Ceph(One shot) | Same as predicate device #2 | PaxScan 4336X: 1.13 | FXRD-1717VA: 1.13 |
| | | | | |
| | | N/A | 1717SCC: 1.13 | N/A |
| | | Same as predicate device #2 | PaxScan 2530C: 1.12 | FXDD-1012CA : 1.12 |
| Scan time | | Same as predicate device #1 | CT : below 14sec(Patient) | CT : below 20sec |
| | | Same as predicate device #1 | Pano : below 14sec | Same as predicate device #1 |
| | | Ceph[Scan type] : below 19.8sec | Ceph[Scan type] : below 19sec | Ceph[Scan size] : below 20sec |
| | | Ceph[One shot type(S)]: below 0.8sec | | |
| | | Ceph[One shot type(L)]: below 0.5sec | Ceph[One shot type]: below 2sec | Same as predicate device #1 |
| Format compatible | | Same as predicate device #1 | DICOM 3.0 Format compatible | Same as predicate device #1 |
| | Image Viewing Software | Same as predicate device #1 | RayScan
(Cleared under K190812) | RayScan
(Cleared under K230753) |
| Image acquisition | | Same as predicate device #1 | Giga-Ethernet Network | Same as predicate device #1 |
| Total Height | | Same as predicate device #1 | Max 2,296mm | Same as predicate device #1 |
| | | 1) Computed Tomography(CT) +
Panoramic(PANO)=150kg(330.7lb) ±
10% | 1) Computed Tomography(CT) +
Panoramic(PANO)=185kg(407.9lb) ±
10% | 1) Computed Tomography(CT) +
Panoramic(PANO)=189kg(416.6lb) ±
10% |
| Weight | | 2) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(Scan type)= 177.5kg (391.3lb) ± 10% | 2) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(Scan type)= 212.5kg (468.5lb) ± 10% | 2) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(Scan type)= 219kg (482.8lb) ± 10% |
| | | 3) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type, installed in Standard
size)= 176kg (388lb) ± 10% | 3) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type, installed in Standard
size)= 211kg (465.2lb) ± 10% | 3) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type, installed in Standard
size)= 217kg (478.4lb) ± 10% |
| | | 4) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type, installed in Large size)
176kg (388lb) ± 10% | 4) Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type, installed in Large size)
211kg (465.2lb) ± 10% | 4) 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 | Same as predicate device #1 |
| Patient position | | Same as predicate device #1 | Standing / Wheelchair | Same as predicate device #1 |
| Applicable
Standards | Same as predicate device #1 | IEC 60601-1
IEC 60601-1-3
IEC 60601-2-63
IEC 60601-1-2 | Same as predicate device #1 | |
7
8
9
10
11
The product is principally just the same as in the previous 510(k) #K190812.
The complete of differences of the subject device to the predicate #190812 device is as follows
-
The maximum X-ray voltage of the tube has been changed from 90kV to 100kV
-
The minimum x-ray current of the tube has been changed from 4mA to 1mA
-
The Ceph(Scan) scan time has been changed from 20sec to 19.8sec
-
Detector (using One-shot).
However, X-ray voltage, X-ray current, one-shot ceph detector was identified in #K230753 The 510(k) for the existing detector used in our equipment is provided below.
| Modality | Detector Model | Cleared | 510(k) No. |
|---|---|---|---|
| CT | FXDD-0606CA | No PMA | K182614 |
| Pano | FXDD-0606CA | No PMA | K182614 |
| Scan Ceph | XID-C24DC | No PMA | K181452 |
| One shot Ceph | FXRD-1717VA | No PMA | K213226 |
| One shot Ceph | FXDD-1012CA | No PMA | K213226 |
12
10. Safety and Effectiveness Information
RAYSCAN α-Expert3D 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, Scan All viewing software programs have been cleared with previous 510k submissions; RAYSCAN(K190812).
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 maximum X-ray voltage of the tube has been changed from 90kV to 100kV
- The minimum x-ray current of the tube has been changed from 4mA to 1mA
- The Ceph(Scan) scan time has been changed from 20sec to 19.8sec
- Detector (using One-shot).
However, X-ray voltage, X-ray current, one-shot ceph detector was identified in #K230753
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/AMD1:2017(first Edition) were performed. EMC testing was conducted in accordance with the standard IEC 60601-1-2: 2014(Edition 4.0).
The software of RAYSCAN α-Expert3D saves patient and image data and offers an inquiry function. In addition, it supports the image generate function intended to obtain images using the RAYSCAN a-Expert3D equipment and various sensors for diagnosis. That has been validated according to the FDA "Guidance for the Content of 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 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 a 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 the FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices". Bench testing is used to assess whether the parameters required to describe functionalities related to imaging properties of the dental X-ray device and patient dosage satisfy the designated tolerance.
Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4 and IEC 61223-3-7. All test results were satisfactory.
Non-clinical considerations were conducted in accordance with the FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices."
Because the subject device uses the same detector as the predicate device, there are no significant differences between the two devices as a result of non-clinical testing.
Clinical considerations were conducted according to the FDA Guidance "Format for Traditional and Abbreviated 510(k)s". Clinical images were provided, and while these images were not necessary to establish substantial equivalence based on the modifications to the device, they provide further evidence, in addition to the laboratory performance data, to show that the complete system works as intended.
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Pediatric information related to the use of this device is provided to users in compliance with FDA guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications".
The features of RAYSCAN a-Expert3D were clinically tested and approved by two licensed practitioners/clinicians. Clinical imaging samples were collected from new detectors on the proposed device at the two offices where the predicate device was installed for the clinical test images. These images were gathered from all detectors installed with RAYSCAN a-Expert3D using protocols with random patient age, gender, and size. A licensed practitioner reviewed the sample clinical images and deemed them to be of acceptable quality for the intended use.
11. 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 RAYSCAN a-Expert3D is safe, effective and substantially equivalent to the predicate device as described herein.