(21 days)
Not Found
No
The document explicitly states that the software's main function is image acquisition and transfer and "doesn't have functions of image post-processing." There are no mentions of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a 'digital imaging solution designed for providing general radiographic diagnosis of human anatomy.' It focuses on image acquisition and transfer for diagnostic purposes, not for treating any condition.
Yes.
The device is indicated for "general radiographic diagnosis of human anatomy," which explicitly states its use for diagnostic purposes.
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 technology involves physical hardware.
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 structure of the body, not for testing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details how the device captures X-ray photons and converts them into digital images for display. This is consistent with a medical imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or performing any kind of in vitro test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is used to create images of the human body.
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 functions of the EverestView 4343X are supported by software and the software is of Moderate level of concern. The main function of software is image acquisition and transfer and it doesn't have functions of image post-processing. 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
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. Clinical images are not necessary for the current submission. Successful results of bench testing should be sufficient to show substantial equivalence for the subject device.
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
December 30, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health and Human Services seal. To the right of the seal 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.
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: K223687
Trade/Device Name: X-ray Flat Panel Detectors (EverestView 4343X) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, JAA Dated: December 9, 2022 Received: December 9, 2022
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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, | ||
|---|---|---|
| Esther O. | ||
| Akinnagbe- | ||
| zusterzeel -S | Digitally signed by Esther O. Akinnagbe-zusterzeel -S | |
| Date: 2022.12.30 12:35:26 | ||
| -05'00' | ||
| for Lu Jiang, Ph.D. | ||
| Assistant Director | ||
| Diagnostic X-Ray Systems Team | ||
| DHT8B: Division of Radiological Imaging Device | ||
| and Electronic Products |
OHT8: Office of Radiological Health
Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223687
Device Name
X-ray Flat Panel Detectors (EverestView 4343X)
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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510(k) Summary
K223687
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
November 22, 2022
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 |
|---|---|
| Model Name: | EverestView 4343X |
| 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 Model Name: CareView 1800RF Classification Name: Stationary X-ray system
4
| Regulation Number: | 21 CFR 892.1680 |
|---|---|
| Regulatory Class: | Class II |
| Product Code: | MQB, JAA |
| FDA 510(k) #: | K221549 |
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 functions of the EverestView 4343X are supported by software and the software is of Moderate level of concern. The main function of software is image acquisition and transfer and it doesn't have functions of image post-processing. The detectors can be used for dynamic imaging (fluoroscopy) that is same as Predicate Device.
6. Intended 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.
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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 | To be assigned | K221549 |
| Model | EverestView 4343X | CareView 1800RF |
| 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 | Wired, Cassette | Wired, Cassette |
| Readout
Mechanism | Thin Film Transistor | Thin Film Transistor |
| Image Matrix Size | 4302 × 4302 pixels | 2816 × 2816 pixels |
| Pixel Pitch | 100 μm | 154µm |
| Effective Imaging
Area | 430 mm ×430 mm | 434 mm × 434 mm |
| Grayscale | 16 bit, 65536 grayscale | 16 bit, 65536 grayscale |
| Spatial Resolution | 5.0 line pair/mm | 3.3 line pair/mm |
| MTF | ≥65..........(@ 1lp/mm)
≥20.........(@ 3lp/mm)
≥7..........(@ 5p/mm) | ≥60%..........(@ 1lp/mm)
≥30%..........(@ 2lp/mm)
≥17%..........(@ 3lp/mm) |
| DQE | (@RQA5, 2µGy)
≥62..........(@ 0lp/mm)
≥30.........(@ 3lp/mm)
≥11.........(@ 5lp/mm) | (@RQA5, 2µGy)
≥55%..........(@ 1lp/mm)
≥20%..........(@ 3lp/mm) |
| Pixel matrix | 100µm:4302×4302 (1x1 binning);
200µm: 2150x2150 (2x2 binning)
400 µ m: 1074x1074
(3x3 binning) | 154 µ m: 2816x2816 (1x1 binning);
308 µ m: 1408×1408 (2x2 binning)
462 µ m: 896×896 (3x3 binning) |
| Frame rate | 5fps@2150x2150
20fps@1074×1074 | 4fps@2816x2816
15fps@1408×1408 |
| | | 25fps@896x896 |
| Rated
Power
Supply | DC 24 V, Max. 2 A | DC 24 V, Max.1.25 A |
| Network interface | Gigabit Ethernet | Gigabit Ethernet |
| Imaging Plate | Carbon Fiber Plate | Carbon Fiber Plate |
| Cooling | Air cooling | Air cooling |
| Dimensions | 460mm ×460mm ×15mm | 460mm × 460mm × 28mm |
| Operation | Temperature: +10 ~ +40°C | Temperature: +10 ~ +40˚C |
| | Humidity: 30 ~ 75% (Non-Condensing) | Humidity: 30 ~ 75% (Non-Condensing) |
| | Atmospheric pressure: 700 ~ 1060
hPa | Atmospheric pressure: 700 ~ 1060
hPa |
| Storage and
transportation | Temperature: -20 ~ +55 ℃ | Temperature: -20 ~ +55 ℃ |
| | Humidity: 10 ~ 90% (Non-Condensing)
Atmospheric pressure: 700 ~ 1060
hPa | Humidity: 10 ~ 90% (Non-Condensing)
Atmospheric pressure: 700 ~ 1060
hPa |
| FDA
Utilized
guidance
documents | 1. Guidance for the Submission of
510(k)s for Solid State X-ray
Imaging Devices
2. The 510(k) Program: Evaluating
Substantial Equivalence in
Premarket Notifications[510(k)]
3. Pediatric Information for X-ray
Imaging Device Premarket
Notifications
4. Radio Frequency Wireless
Technology in Medical devices
5. Guidance for the Content of
Premarket Submissions for
Software Contained in Medical
Devices
6. Content of Premarket Submissions
for Management of Cybersecurity
in Medical Devices | 1. Guidance for the Submission of
510(k)s for Solid State X-ray
Imaging Devices
2. The 510(k) Program: Evaluating
Substantial Equivalence in
Premarket Notifications[510(k)]
3. Pediatric Information for X-ray
Imaging Device Premarket
Notifications
4. Radio Frequency Wireless
Technology in Medical devices
5. Guidance for the Content of
Premarket Submissions for
Software Contained in Medical
Devices
6. Content of Premarket Submissions
for Management of Cybersecurity
in Medical Devices |
6
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
7
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. -
A Nonclinical and clinical considerations
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. Clinical images are not necessary for the current submission. Successful results of bench testing should be sufficient to show substantial equivalence for the subject device.
10. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based
8
on the information provided in this premarket notification, the proposed devices are substantially equivalent to predicate device CareView 1800RF X-ray flat panel detectors (K221549). 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.