(55 days)
Not Found
No
The summary describes a digital radiographic scanner that processes and displays images, but there is no mention of AI or ML being used for image analysis, interpretation, or any other function. The processing described appears to be standard digital image processing.
No
The device is a digital radiographic scanner for dental diagnostics, used to create and display digital images; it does not directly treat or diagnose a disease or condition.
Yes
The device's "Intended Use/Indications for Use" explicitly states it is "a digital radiographic scanner for dental diagnostics." It also mentions that scanned images are used with "PortView, a dental diagnostic software package, and other diagnostic software."
No
The device description explicitly states that GenX-CR is composed of hardware components including a PSP Scanner, PSP tray, power adapter and cable, Ethernet cable, PSP transfer box, PSP, PSP Protective Cover, and Hygenic Bag, in addition to software and firmware.
Based on the provided information, the GenX-CR 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.
- GenX-CR Function: The GenX-CR is a digital radiographic scanner that processes and displays images from intraoral X-ray plates. It is used for dental diagnostics by creating and displaying images of the internal structures of the mouth.
- No Biological Samples: The device does not analyze biological samples from the patient. Its input is a physical image plate containing an X-ray image.
Therefore, the GenX-CR falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
GenX-CR is a digital radiographic scanner for dental diagnostics intended for use by dentists and other qualified professionals.
This device is used to create and display digital images by scanning intraoral X-ray images stored in an Image Plate (or Phosphore Storage Plate).
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
GenX-CR scans a reusable phosphor storage plate (hereinafter referred to as "PSP") instead of an analog film to acquire high-quality digital radiographic images, digitally processes them, and displays images on the equipment's touch display screen and computer screen. It's a scanner. *PSP is also known as IP (Image Plate)
After scanning the PSP, the image is saved in the device's internal memory, the scanned image can be checked in advance through the touch display, and the image stored in the PSP can be deleted and the PSP can be ejected. Scanned images can be directly transmitted to a computer or network via an Ethernet cable and are used in PortView, a dental diagnostic software package, and other diagnostic software.
GenX-CR is composed of mainly consists of PSP Scanner, PSP tray, power adapter and cable, Ethernet cable, PSP transfer box, PSP, PSP Protective Cover, Hygenic Bag, Dental PSP scanner control system software (Version: V2.2)
GenX-CR contains firmware that is part of the system. And we hereby certify that the level of concern for this software(PortView) and firmware(GenX-OP) is of Moderate level of concern. And It has not been cleared with other predicate devices but is the initial used in GenX-CR
Its compact design allows installation in space-constrained locations and minimizeds operating costs by using a low-cost, reusable PSP.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intraoral X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists and other qualified 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
GenX-CR has been successfully completed verification and validation testing per GENORAY quality system and engineering bench testing in support of successfully completed verification and validation testing per GENORAY quality system and this submission. The system has been tested and is compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62366.
And Software was validated according to the FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical devices", FDA Guidance "Guidance for the content of premarket submissions for management of cyber security". Results demonstrated that all executed verification tests were passed.
Non-clinical validation testing has been performed to validate that GenX-CR conforms to the intended use, claims, user needs, effectiveness of safety measures, and instructions for use. Clinical testing was not necessary for the subject device, to demonstrate substantial equivalence.
As a result, all test results were satisfactory, and the result of bench tests indicates that the new device is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Resolution: 12 lp/mm @ 25um
DQE at 10% efficiency: 2.8 lp/mm
MTF at 3lp/mm: 35%
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
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
September 13, 2023
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
Genoray Co., Ltd. % Ms. Kaitlynn Min Business Development GENORAY America Inc. 1220 N Simon Circle, Unit B ANAHEIM CA 92806
Re: K232158
Trade/Device Name: GenX-CR Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: July 19, 2023 Received: July 20, 2023
Dear Ms. Min:
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 Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Indications for Use (Describe)
GenX-CR is a digital radiographic scanner for dental diagnostics intended for use by dentists and other qualified professionals.
This device is used to create and display digital images by scanning intraoral X-ray images stored in an Image Plate (or Phosphore Storage Plate).
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------ |
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510(k) Summary
This 510(k) summary information is prepared in accordance with 21 CFR 807.92
1. Date of Summary Preparation [21 CFR 807.92(a) (1)]_
: Jul. 14, 2023
2. Administrative Information [21 CFR 807.92(a) (1)]
| 510(k) Submitter | GENORAY Co.,Ltd
Address: 512, 560, Dunchon-daero, Jungwon-gu,
Seongnam-si, Gyeonggi-Do, Korea
Telephone No.: +82-31-5178-5500
Fax: +82-31-5178-5599
Contact Person: Inyoung Kim (iykim@genoray.com) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent | GENORAY America Inc.
Address: 1220N Simon Circle, B, Anaheim, CA 92806 USA
Telephone No.: +1-855-436-6729
Fax: +1-714-786-8919
Contact Person: Kaitlynn Min (kaitlynn@genorayamerica.com) |
3. Device Information [21 CFR 807.92(a) (2)]
| Trade / Device Name | GenX-CR |
|---|---|
| Requlation Name | Extraoral source X-ray system |
| Classification Regulation | 21 CFR 872.1800 |
| Class of Device | Class II |
| Panel | Radiology |
| Product Code | MUH |
4. Predicate Device Information [21 CFR 807.92(a) (3)]
| * Predicate Device | |
|---|---|
| Name of Device | CRUXCAN(CRX-1000) |
| Manufacturer | CRUXELL Corp. |
| Regulation Name | Extraoral source X-ray system |
| Classification Regulation | 21 CFR 872.1800 |
| Class of Device | Class II |
| Panel | Radiology |
| Product Code | MUH |
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5. Description of the Device [21 CFR 807.92(a) (4)]
GenX-CR scans a reusable phosphor storage plate (hereinafter referred to as "PSP") instead of an analog film to acquire high-quality digital radiographic images, digitally processes them, and displays images on the equipment's touch display screen and computer screen. It's a scanner. *PSP is also known as IP (Image Plate)
After scanning the PSP, the image is saved in the device's internal memory, the scanned image can be checked in advance through the touch display, and the image stored in the PSP can be deleted and the PSP can be ejected. Scanned images can be directly transmitted to a computer or network via an Ethernet cable and are used in PortView, a dental diagnostic software package, and other diagnostic software.
GenX-CR is composed of mainly consists of PSP Scanner, PSP tray, power adapter and cable, Ethernet cable, PSP transfer box, PSP, PSP Protective Cover, Hygenic Bag, Dental PSP scanner control system software (Version: V2.2)
GenX-CR contains firmware that is part of the system. And we hereby certify that the level of concern for this software(PortView) and firmware(GenX-OP) is of Moderate level of concern. And It has not been cleared with other predicate devices but is the initial used in GenX-CR
Its compact design allows installation in space-constrained locations and minimizeds operating costs by using a low-cost, reusable PSP.
6. Indications for use [21 CFR 807.92(a) (5)]
GenX-CR is a digital radiographic scanner for dental diagnostics intended for use by dentists and other qualified professionals.
This device is used to create and display digital images by scanning intraoral X-ray images stored in an Image Plate (or Phosphor Storage Plate).
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7. Substantial equivalence chart [21 CFR 807.92(a) (6)]
| Proposed device | Predicate device | SE Note | |
|---|---|---|---|
| GenX-CR | CRUXCAN(CRX-1000) | ||
| Manufacturer | GENORAY Co., Ltd | CRUXELL Corp. | - |
| 510(k) No. | K232158 | K183637 | - |
| Regulation Name | Extraoral source X-ray system | Extraoral source X-ray system | - |
| Classification name | System, X-ray, Extraoral Source, Digital | System, X-ray, Extraoral Source, Digital | - |
| Common Name | Dental PSP Scanner | Dental PSP Scanner | - |
| Product Code | MUH | MUH | - |
| Regulation Number | 872.1800 | 872.1800 | - |
| Class | Class II | Class II | - |
| Product illustraion | Image: GenX-CR | Image: CRUXCAN(CRX-1000) | - |
| Indications for use | GenX-CR is a digital radiographic scanner | ||
| for dental diagnostics intended for use by | The CRUXCAN (CRX-1000) is indicated for | ||
| capturing, digitization and processing of | Same | ||
| dentists and other qualified professionals. | |||
| This device is used to create and display | |||
| digital images by scanning intraoral X-ray | |||
| images stored in an Image Plate (or | |||
| Phosphore Storage Plate). | intra-oral x-ray images stored in imaging | ||
| plate recording media. | |||
| Image File Format | TIFF / Raw Format | TIFF / Raw Format | Same |
| Power Supply | 50/60 Hz, 100-240V~ | 50/60 Hz, 100-240V~ | Same |
| X-ray Absorber | Imaging Plate | Imaging Plate | Same |
| Image plate Size | Size 0 : 22 x 31mm | ||
| Size 1 : 24 x 40 mm | |||
| Size 2 : 31 x 41mm | |||
| Size 3 : 27 x 54 mm | Size 0 : 22 x 31mm | ||
| Size 1 : 24 x 40 mm | |||
| Size 2 : 31 x 41mm | |||
| Size 3 : 27 x 54 mm | Same | ||
| Image Pixel Size | 25 um (High Resolution) | ||
| 50 um (Standard Resolution) | 25 um | ||
| 50 um | Same | ||
| Gray Scale level | 16 bit | 8 bit / 16 bit | Same |
| Resolution | 12 lp/mm @ 25um | 14.0 lp/mm @ 25um | Similar |
| Imaging Plate | |||
| Performance |
- DQE
- MTF | DQE at 10% efficiency: 2.8 lp/mm
MTF at 3lp/mm: 35% | DQE at 10% efficiency: 2.8 lp/mm
MTF at 3lp/mm: 35% | Same |
| Laser safety
classification | Class 1 laser product EN60825-1:2014 | Class 1 laser product EN60825-1:2014 | Same |
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8. Safety, EMC and Performance data comparison to Predicate [21 CFR 807.92(b)]
GenX-CR has been successfully completed verification and validation testing per GENORAY quality system and engineering bench testing in support of successfully completed verification and validation testing per GENORAY quality system and this submission. The system has been tested and is compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62366.
And Software was validated according to the FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical devices", FDA Guidance "Guidance for the content of premarket submissions for management of cyber security". Results demonstrated that all executed verification tests were passed.
Non-clinical validation testing has been performed to validate that GenX-CR conforms to the intended use, claims, user needs, effectiveness of safety measures, and instructions for use. Clinical testing was not necessary for the subject device, to demonstrate substantial equivalence.
As a result, all test results were satisfactory, and the result of bench tests indicates that the new device is as safe and effective as the predicate device.
9. Conclusion
In reference to the comparison information provided in the substantial equivalence chart, and the most of functions and electronic features are similar to the predicate device. We believe that the GenX-CR is safe and effective as a predicate device and has no new indication for use. Therefore, GenX-CR is substantially equivalent to a predicate device.