(23 days)
Not Found
No
The summary describes a standard digital X-ray detector and its image acquisition and transfer software. There is no mention of AI, ML, or advanced image processing that would typically indicate the presence of such technology. The software is described as having a "Moderate level of concern" and its main function is "image acquisition and transfer," which are not indicative of AI/ML capabilities.
No.
The device is used for diagnosis (imaging), not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the detector is "designed for providing general radiographic diagnosis of human anatomy."
No
The device description clearly outlines hardware components (scintillator, photo detectors, a-Si array) that are integral to the device's function of intercepting X-ray photons and converting them into electrical signals. While software is mentioned as supporting functions like image acquisition and transfer, the core device is a physical detector.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "digital imaging solution designed for providing general radiographic diagnosis of human anatomy." This describes a device used for imaging the internal structures of the body, not for examining specimens taken from the body (like blood, urine, or tissue).
- Device Description: The description details how the device works by intercepting X-ray photons and converting them into digital images. This is consistent with a medical imaging device, not an IVD.
- Input Imaging Modality: The input modality is X-ray, which is a form of medical imaging, not a method used for in vitro diagnostics.
- Anatomical Site: The anatomical site is "human anatomy," indicating the device is used on the body itself.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
In summary, the device is a digital X-ray detector used for medical imaging, which falls under the category of medical devices, but not specifically in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
Product codes
MQB, JAA
Device Description
The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor.
The detector should be connected to a computer and X-ray generator for transfer of diagnostic images (the x-ray generator and the computer are not part of the submission). The functions of the YosemiteView 4343W/ YosemiteView 3643W are supported by software and the software is of Moderate level of concern. The main function of software is image acquisition and transfer. The detectors can be used for dynamic imaging (fluoroscopy) that is same as Predicate Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Nonclinical and clinical considerations A
The proposed devices and predicate device share most of primary product specifications including intended use, technology, material, and imaging principle, power supply method etc. The only difference is the wireless function and dimension. The difference of wireless function and dimension don't affect the technological parameters and clinical images.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 3, 2023
CareRay Digital Medical Technology Co., Ltd. % Xu Wei Manager A2-201/B3-501, Biobay 218 Xinghu Street. SuZhou Industrial Park, Suzhou. Jiangsu 215123 CHINA
Re: K232058
Trade/Device Name: YosemiteView 4343W/YosemiteView 3643W Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, JAA Dated: June 28, 2023 Received: July 11, 2023
Dear Xu Wei:
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) K232058
Device Name
YosemiteView 4343W/YosemiteView 3643W
Indications for Use (Describe)
The detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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006_510(k) Summary
4
510(k) Summary
K 232058
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
June 28, 2023
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Company Name: | CareRay Digital Medical Technology Co., Ltd. |
|---|---|
| Company Address: | A2-201/B3-501, Biobay, 218 Xinghu Street, Suzhou |
| Industrial Park, Suzhou 215123, P. R. China | |
| Contact Person: | Mr. Xu |
| Phone Number: | (86) 512-86860288 |
| Fax Number: | (86) 512-86860388 |
| E-mail: | Wei.xu@careray.com |
3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]
| Trade Name: | X-ray Flat Panel Detectors |
|---|---|
| Device Name: | YosemiteView 4343W/ YosemiteView 3643W |
| Classification Name: | Stationary X-ray system |
| Regulation Number: | 21 CFR 892.1680 |
| Regulatory Class: | Class II |
| Product Code: | MQB,JAA |
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified primary predicates within this submission are as follows:
| Manufacturer: | CareRay Digital Medical Technology Co., Ltd. |
|---|---|
| Trade Name: | X-ray Flat Panel Detectors |
| Device Name: | EverestView 4343X |
| Classification Name: | Stationary X-ray system |
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| Regulation Number: | 21 CFR 892.1680 |
|---|---|
| Regulatory Class: | Class II |
| Product Code: | MQB, JAA |
| FDA 510(k) #: | K223687 |
5. Description of the Device [21 CFR 807.92(a)(4)]
The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor.
The detector should be connected to a computer and X-ray generator for transfer of diagnostic images (the x-ray generator and the computer are not part of the submission). The functions of the YosemiteView 4343W/ YosemiteView 3643W are supported by software and the software is of Moderate level of concern. The main function of software is image acquisition and transfer. The detectors can be used for dynamic imaging (fluoroscopy) that is same as Predicate Device.
6. Indications for Use [21 CFR 807.92(a)(5)]
The detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
6
7. Technological Characteristics [21 CFR 807.92(a)(6)]
Comparison with the predicate device
| Item | Proposed Device:
X-ray Flat Panel Detectors | | Predicate Device :
X-ray Flat Panel Detectors |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K232058 | | K223687 |
| Model | YosemiteView
4343W | YosemiteView
3643W | EverestView 4343X |
| Intended Use | The detector is indicated for digital
imaging solution designed for
providing general radiographic
diagnosis of human anatomy. It is
intended to replace radiographic
film/screen systems in all
general-purpose diagnostic
procedures. This product is not
intended for mammography
applications. | | The detector is indicated for digital
imaging solution designed for
providing general radiographic
diagnosis of human anatomy. It is
intended to replace radiographic
film/screen systems in all
general-purpose diagnostic
procedures. This product is not
intended for mammography
applications. |
| Classification
Name | Stationary X-ray system | | Stationary X-ray system |
| Product Code | MQB,JAA | | MQB,JAA |
| Regulation
Number | 892.1680 | | 892.1680 |
| Panel | Radiology | | Radiology |
| Class | II | | II |
| X-ray Absorber | Csl Scintillator | | Csl Scintillator |
| Installation Type | Wireless, Wired, Cassette | | Wired, Cassette |
| Readout
Mechanism | Thin Film Transistor | | Thin Film Transistor |
| Image Matrix Size | 4352×4352 pixels | 3584×4352pixels | 4302 ×4302 pixels |
| Pixel Pitch | 100 μm | | 100 μm |
| Effective Imaging
Area | 430 mm × 430 mm | 430 mm × 356 mm | 430 mm × 430 mm |
| Grayscale | 16 bit, 65536 grayscale | | 16 bit, 65536 grayscale |
| Spatial Resolution | 5.0 line pair/mm | | 5.0 line pair/mm |
| MTF | ≥65..........(@ 1lp/mm)
≥35.........(@ 2lp/mm)
≥20..........(@ 3p/mm) | | ≥65..........(@ 1lp/mm)
≥20.........(@ 3lp/mm)
≥7..........(@ 5p/mm) |
| DQE | (@RQA5, 10µGy)
≥50..........(@ 1lp/mm)
≥30.........(@ 3lp/mm) | | (@RQA5, 2µGy)
≥62..........(@ 0lp/mm)
≥30.........(@ 3lp/mm)
≥11.........(@ 5lp/mm) |
| Pixel matrix | 100μm:4352×4352 (1x1 binning);
200μm:
2176x2176(2x2 binning) | 100µm:
3584×4352 (1x1 binning);
200µm:
1792x2176 (2x2 | 100μm:4302×4302 (1x1 binning);
200μm: 2150x2150 (2x2 binning)
400 μ m: 1074x1074
(3x3 binning) |
7
8
8. System requirements to operate with other radiographic system components
The submitted medical device is the X-ray Flat Panel Detector. The other x-ray system components referred below are for information purpose only.
-
- Recommended Generator Specification:
Energy range: 40~150kVp
- Recommended Generator Specification:
mA range: 10~1000mA (depending on the generator power)
ms range: 106300ms to produce 0.11000mAs (depending on the generator power) Note: To our best knowledge, the detector is compatible with the X-ray generators with the specifications described above. If you have questions regarding the compatibility issue for other generators, please contact your distributor or CareRay.
-
- Application Program Interface (API) for system integration manufacturer Peripheral hardware: CareView detector connected via wired communication. CPU: Intel (R) Core (TM) 2 Duo, 2.93GHz or above RAM: 6 GB or higher Hard disk: 80 GB or higher Monitor: 1280 x 1024 or higher OS: Windows 7 or Windows 10 Development environment: MS Visual Studio 2005
-
- X-ray exposure mode
The synchronous connection mode is the signal transfer mode between the X-ray generator which sends the X-ray and the detector which receives the X-ray.
The detectors support typical sync mode contains external sync mode.
The detector can't provide feedback to the generator to terminate the x-ray exposure.
9. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92(b)(2)]
-
A Electrical safety and EMC testing
Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 was performed, and EMC testing was also conducted in accordance with IEC/EN 60601-1-2. All test results are satisfactory. -
Nonclinical and clinical considerations A
The proposed devices and predicate device share most of primary product specifications including intended use, technology, material, and imaging principle, power supply method etc. The only difference is the wireless function and dimension. The difference of wireless
9
function and dimension don't affect the technological parameters and clinical images.
10. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, the proposed devices are substantially equivalent to predicate device EverestView 4343X X-ray flat panel detectors (K223687). Both propose and predicate devices are same in the intended use, the design principle and the applicable standards. Therefore, CareRay Digital Medical Technology Co., Ltd. concludes the proposed devices are substantially equivalent with the predicate device with regard to safety and effectiveness.