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.

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.

AI/ML Overview

The provided document is a 510(k) Summary for the CareRay Digital Medical Technology Co., Ltd. YosemiteView 4343W/YosemiteView 3643W X-ray Flat Panel Detectors. It aims to demonstrate substantial equivalence to a predicate device, the EverestView 4343X.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with performance targets. Instead, it provides a "Comparison with the predicate device" table that lists technical specifications for both the proposed device and the predicate device. The implied acceptance is that the proposed device's performance is, at least, equivalent to or better than the predicate device.

Item	Proposed Device: YosemiteView 4343W/3643W	Predicate Device: EverestView 4343X	Comparison and Implied Acceptance
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.	Identical
Classification Name	Stationary X-ray system	Stationary X-ray system	Identical
Product Code	MQB, JAA	MQB, JAA	Identical
Regulation Number	892.1680	892.1680	Identical
Panel	Radiology	Radiology	Identical
Class	II	II	Identical
X-ray Absorber	CsI Scintillator	CsI Scintillator	Identical
Installation Type	Wireless, Wired, Cassette (Proposed device adds Wireless capability)	Wired, Cassette	Proposed is enhanced
Readout Mechanism	Thin Film Transistor	Thin Film Transistor	Identical
Image Matrix Size	YosemiteView 4343W: 4352×4352 pixelsYosemiteView 3643W: 3584×4352 pixels	EverestView 4343X: 4302 ×4302 pixels	Proposed has larger for 4343W
Pixel Pitch	100 µm	100 µm	Identical
Effective Imaging Area	YosemiteView 4343W: 430 mm × 430 mmYosemiteView 3643W: 430 mm × 356 mm	EverestView 4343X: 430 mm × 430 mm	Proposed matches or is smaller
Grayscale	16 bit, 65536 grayscale	16 bit, 65536 grayscale	Identical
Spatial Resolution	5.0 line pair/mm	5.0 line pair/mm	Identical
MTF	≥65 (@ 1lp/mm)≥35 (@ 2lp/mm)≥20 (@ 3lp/mm)	≥65 (@ 1lp/mm)≥20 (@ 3lp/mm)≥7 (@ 5lp/mm)	Proposed is better or similar*
DQE	(@RQA5, 10µGy)≥50 (@ 1lp/mm)≥30 (@ 3lp/mm)	(@RQA5, 2µGy)≥62 (@ 0lp/mm)≥30 (@ 3lp/mm)≥11 (@ 5lp/mm)	Proposed is similar for 3lp/mm, but tested at higher dose; difficult to directly compare 0lp/mm and 1lp/mm given different doses.
Pixel matrix	100μm: 4352×4352 (1x1 binning);200μm: 2176x2176 (2x2 binning) (for 4343W)100µm: 3584×4352 (1x1 binning);200µm: 1792x2176 (2x2) (for 3643W)	100μm: 4302×4302 (1x1 binning);200μm: 2150x2150 (2x2 binning)400 μm: 1074x1074 (3x3 binning)	Proposed matches or is finer binning, 400µm binning not present.

*Note on MTF: The proposed device reports MTF at 2lp/mm (≥35) which the predicate does not. For 1lp/mm, both are ≥65. For 3lp/mm, the proposed is ≥20 while the predicate is also ≥20. The predicate reports 5lp/mm (≥7) which the proposed does not. Based on available comparable points, the proposed device meets or exceeds the predicate's reported MTF.

2. Sample size used for the test set and the data provenance

The document states "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."

This statement, coupled with the lack of details on a separate clinical image test set, suggests that a dedicated clinical image test set for comparing performance (e.g., diagnostic accuracy) was likely not used for the substantial equivalence demonstration, beyond confirming the effect of the new features (wireless function and dimension) on "technological parameters and clinical images." The report focuses heavily on technical specifications and electrical safety.

Therefore, information on sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Given the lack of details on a dedicated clinical image test set (as discussed in point 2), there is no information provided about the number or qualifications of experts used to establish ground truth for such a set. The submission relies on "Nonclinical and clinical considerations" that attribute no significant impact from the changes.

4. Adjudication method for the test set

Similarly, because details of a clinical image test set are absent, the adjudication method is not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document describes the device as an X-ray Flat Panel Detector, which captures images. There is no mention of an AI component or a multi-reader multi-case (MRMC) comparative effectiveness study. The device's function is "image acquisition and transfer" (page 5).

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device is an imaging hardware component; it is not an algorithm that performs standalone diagnostic tasks. Therefore, a standalone algorithm performance study was not applicable and not performed/reported.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

As noted in point 2, a specific clinical image test set with established ground truth types (expert consensus, pathology, outcomes data) is not detailed in this document. The submission relies on demonstrating substantial equivalence based on technical specifications and the assertion that differences in wireless function and dimension do not affect technological parameters or clinical images.

8. The sample size for the training set

The device is a hardware component (X-ray Flat Panel Detector), not an AI algorithm requiring a training set in the conventional sense. While there might have been internal testing and calibration data, the document does not refer to a "training set" in the context of machine learning, nor does it provide a sample size for such.

9. How the ground truth for the training set was established

As there is no mention of an AI training set, this information is not applicable or provided.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K232058

Device Name

YosemiteView 4343W/YosemiteView 3643W

Indications for Use (Describe)

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

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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, SuzhouIndustrial 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)]

6. Indications for Use [21 CFR 807.92(a)(5)]

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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	YosemiteView4343W	YosemiteView3643W	EverestView 4343X
Intended Use	The detector is indicated for digitalimaging solution designed forproviding general radiographicdiagnosis of human anatomy. It isintended to replace radiographicfilm/screen systems in allgeneral-purpose diagnosticprocedures. This product is notintended for mammographyapplications.		The detector is indicated for digitalimaging solution designed forproviding general radiographicdiagnosis of human anatomy. It isintended to replace radiographicfilm/screen systems in allgeneral-purpose diagnosticprocedures. This product is notintended for mammographyapplications.
ClassificationName	Stationary X-ray system		Stationary X-ray system
Product Code	MQB,JAA		MQB,JAA
RegulationNumber	892.1680		892.1680
Panel	Radiology		Radiology
Class	II		II
X-ray Absorber	Csl Scintillator		Csl Scintillator
Installation Type	Wireless, Wired, Cassette		Wired, Cassette
ReadoutMechanism	Thin Film Transistor		Thin Film Transistor
Image Matrix Size	4352×4352 pixels	3584×4352pixels	4302 ×4302 pixels
Pixel Pitch	100 μm		100 μm
Effective ImagingArea	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)

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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.

1. Recommended Generator Specification:
  Energy range: 40~150kVp

mA range: 10~1000mA (depending on the generator power)

ms range: 10~~6300ms to produce 0.1~~1000mAs (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.

1. 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
1. 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

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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.

Regulation Number and Section

§ 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.