Who is the manufacturer of RAYSCAN a-Expert3D?

Ray Co., Ltd. filed the 510(k) submission for RAYSCAN a-Expert3D (K232287).

What is the FDA product code for RAYSCAN a-Expert3D?

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

What is the regulatory pathway for RAYSCAN a-Expert3D?

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

Who can help prepare an FDA 510(k) submission like RAYSCAN a-Expert3D?

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.

RAYSCAN a-Expert3D

K232287 · Ray Co., Ltd. · OAS · Aug 31, 2023 · Radiology

Device Facts

Record ID	K232287
Device Name	RAYSCAN a-Expert3D
Applicant	Ray Co., Ltd.
Product Code	OAS · Radiology
Decision Date	Aug 31, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	Pediatric

Intended 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 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.

Device Story

Extra-oral dental X-ray system; utilizes C-arm with high-voltage generator, X-ray tube, and flat panel detector. Operates by rotating C-arm around patient to acquire projection data; reconstructs 3D dentomaxillofacial volumes via CBCT technique. Includes panoramic and cephalometric imaging options. Used in dental clinics by dentists or qualified healthcare professionals. Output consists of 2D panoramic/cephalometric images and 3D reconstructed volumes viewed on external workstations. Supports diagnostic assessment of teeth, jaw, and oral structures. Benefits include high-resolution imaging for implant planning, TMJ studies, and orthodontic assessment. System integrates with console PC for image acquisition and management.

Clinical Evidence

Clinical imaging samples collected from two dental offices using the new detectors. Images obtained from patients of random age, gender, and size. Two licensed practitioners reviewed the clinical images and deemed them of acceptable quality for the intended use. No diagnostic accuracy metrics (sensitivity/specificity) reported; clinical data provided as supplemental evidence to bench testing.

Technological Characteristics

Extra-oral X-ray system; CBCT, panoramic, and cephalometric modalities. High-frequency generator; 60-100kVp; 1-17mA. Flat panel detectors (e.g., FXDD-0606CA, XID-C24DC, FXRD-1717VA). Connectivity via Giga-Ethernet to console PC. DICOM 3.0 compatible. Standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-2-63, IEC 60601-1-2 (EMC).

Indications for Use

Indicated for dental radiographic examination of teeth, jaw, and oral structures (panoramic, implantology, TMJ, cephalometry, and dentomaxillofacial 3D imaging) in adult and pediatric patients (recommended age >5 years).

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

RAYSCAN α-Expert3D (K190812)

Reference Devices

RCT800 (K230753)

Related Devices

K160525 — RCT700 · Ray Co., Ltd. · Jun 20, 2016
K142247 — RAYSCAN A-EXPERT 3D · Ray Co., Ltd. · Apr 17, 2015
K200688 — hyperion X5, NewTom GO, X-RADiUS COMPACT · Cefla S.C. · Apr 9, 2020
K131695 — RAYSCAN A-EXPERT 3D · Ray Co., Ltd. · Nov 1, 2013
K193139 — ProVecta 3D Prime Ceph · Durr Dental SE · Mar 5, 2020

Submission Summary (Full Text)

{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) K232287 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. X 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." 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 | | | Email | 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 2) Panoramic 3) Cephalometric(optional) - One shot type - Scan type | 1) CBCT Computed tomography - Patient - Dental Model Scan(Optional) 2) Panoramic 3) 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 | 60~90kVp | 60~100kVp | | X-ray Current(Patient) | | Same as predicate device #2 | 4~17mA | 1~17mA | | 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…