(460 days)
Not Found
No
The description focuses on the hardware components and basic image processing (conversion, composition, transmission) of an X-ray detector. There is no mention of AI, ML, or any advanced algorithms for image analysis or interpretation. The performance studies are standard tests for detector characteristics and a simple concurrence study comparing image quality to a predicate device.
No
The device is an X-ray flat panel detector, primarily used for acquiring digital images for diagnostic purposes, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for medical application" and "for providing general radiographic system in all general purpose diagnostic procedures."
No
The device description explicitly details hardware components like a TFT/PD image sensor flat panel, scintillator, diode capacitor array, and scanning/readout electronics, indicating it is a physical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "digital imaging solution designed for providing general radiographic system in all general purpose diagnostic procedures." This describes a medical imaging device used to capture images of the inside of the body, not a device used to examine specimens from the body (like blood, urine, or tissue) outside of the body.
- Device Description: The description focuses on how the device converts X-rays into digital images. This is consistent with a medical imaging device, not an IVD.
- Input Imaging Modality: The input is X-ray, which is a form of radiation used for imaging the body, not for analyzing biological samples.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to capture images using X-rays, which falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
CareView 1800R X-ray Flat Panel Detectors is indicated for digital imaging solution designed for providing general radiographic system in all general purpose diagnostic procedures. CareView 1800R X-ray Flat Panel Detectors is a component of a digital imaging system. Properly integrated into a completed X-ray system, the digital X-ray imaging intended for medical application.
This product is not intended for mammography applications and dental X-ray applications.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
CareView 1800R X-ray Flat Panel Detectors supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 43cm×43cm. The sensor plate of CareView 1800R X-ray Flat Panel Detectors is direct-deposited with Csl scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface.
The major function of the CareView 1800R X-ray Flat Panel Detectors detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
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
A concurrence study of 30 clinical images was conducted to compare the performance of the CareView 1800R to that of the predicate device (K050987).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
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. Section 201.7.2.7, 201.7.9.1, 201.7.9.2.1.103 and 203.4.1 of IEC 60601-2-54 were also conducted. -
A Nonclinical considerations
The following non-clinical studies have been performed and the results have shown that the CareView 1800R X-ray flat panel detector is substantially equivalent to the predicate devices on the Market (CXDI-40EG).
-Detective quantum efficiency (DQE), Quantum limited performance, Modulation transfer function (MTF), Effects of aliasing, Sensitivity linearity, Lag(Erasure thoroughness), Change in detection sensitivity, Dose requirement and reciprocity changes, Stability of device characteristics with time, Uniformity of device characteristic, Noise power spectrum(NPS), Spatial resolution, Image Acquisition time, & Black level -
A Clinical considerations
A concurrence study of 30 clinical images was conducted to compare the performance of the CareView 1800R to that of the predicate device (K050987).
Clinical images were provided; these images were not necessary to establish substantial equivalence based on the superior performance in comparison to the predicate based on laboratory testing and based on the use of a detector scintillator material that is already on the marketplace; however, they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
There was no significant difference between the images of the CareView 1800R and those of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2015
CareRay Digital Medical System Co., Ltd. % Jamie Ku Official Correspondent Compass Innovations, Inc. 3001 Winchester Blvd, Suite 3 CAMPBELL CA 95008
Re: K141488
Trade/Device Name: CareView 1800R X-ray Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 13, 2015 Received: August 17, 2015
Dear Jamie Ku:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141488
Device Name CareView 1800R X-ray Flat Panel Detectors
Indications for Use (Describe)
CareView 1800R X-ray Flat Panel Detectors is indicated for digital imaging solution designed for providing general radiographic system in all general purpose diagnostic procedures. CareView 1800R X-ray Flat Panel Detectors is a component of a digital imaging system. Properly integrated into a completed X-ray system, the digital X-ray imaging intended for medical application.
This product is not intended for mammography applications and dental X-ray 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) |
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."
3
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
August 13, 2015
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Company Name: | CareRay Digital Medical System Co., Ltd. |
|---|---|
| Company Address: | Suite 201, Building A2, BIOBAY, 218 Xing Hu Street, |
| SuZhou Industrial Park, SuZhou 215123, P.R.China | |
| Contact Person: | Ms. Ding |
| Phone Number: | (86) 512-86860288 |
| Fax Number: | (86) 512-86860388 |
| E-mail: | yl.ding@careray.com |
3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]
| Trade Name: | X-ray Flat Panel Detectors |
|---|---|
| Model Name: | CareView 1800R |
| Classification Name: | Stationary X-ray system |
| Regulation Number: | 21 CFR 892.1680 |
| Regulatory Class: | Class II |
| Product Code: | MQB |
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
The identified predicates within this submission are as follows:
| Manufacturer: | Canon Inc. |
|---|---|
| Trade Name: | Canon |
| Model Name: | CXDI-40EG |
| Classification Name: | Stationary X-ray system |
| Regulation Number: | 21 CFR 892.1680 |
| Regulatory Class: | Class II |
4
| Product Code: | MQB |
|---|---|
| FDA 510(k) #: | K050987 |
5. Description of the Device [21 CFR 807.92(a)(4)]
CareView 1800R X-ray Flat Panel Detectors supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 43cm×43cm. The sensor plate of CareView 1800R X-ray Flat Panel Detectors is direct-deposited with Csl scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface.
The major function of the CareView 1800R X-ray Flat Panel Detectors detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software.
6. Intended Use [21 CFR 807.92(a)(5)]
CareView 1800R X-ray Flat Panel Detectors is indicated for digital imaging solution designed for providing general radiographic system in all general purpose diagnostic procedures. CareView 1800R X-ray Flat Panel Detectors is a component of a digital imaging system. Properly integrated into a completed X-ray system, the detector enables the digital X-ray imaging intended for medical application.
This product is not intended for mammography applications and dental X-ray applications.
| Item | Proposed Device:
CareView 1800R X-ray Flat Panel
Detectors | Predicate Device: CXDI-40EG |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)
Number | To be assigned | K050987 |
| Intended Use | The CareView 1800R X-ray Flat
Panel Detectors is indicated for
digital imaging solution designed
for providing general radiographic
system in all general purpose
diagnostic procedures. CareView
1800R X-ray Flat Panel Detectors
is a component of a digital imaging
system. Properly integrated into a | DIGITAL RADIOGRAPHY
CXDI-40EG provides digital
image capture for conventional
film/screen radiographic
examinations. The device is
intended to replace radiographic
film/screen systems in all general
purpose diagnostic procedures. |
| | completed X-ray system, the
detector enables the digital X-ray
imaging intended for medical
application.
This product is not intended for
mammography applications and
dental X-ray applications. | |
| Classification
Name | Stationary X-ray system | Stationary X-ray system |
| Product
Code | MQB | MQB |
| Regulation
Number | 21 CFR 892.1680 | 21 CFR 892.1680 |
| Panel | Radiology | Radiology |
| Class | II | II |
| X-ray
Absorber | CsI Scintillator | GOS |
| Installation
Type | Stationary, permanently installed | Stationary, permanently installed |
| Readout
Mechanism | Thin Film Transistor | Thin Film Transistor |
| Detector
Size | 492 x 492 x 33.5 mm | 550 x 550 x 67.5 mm |
| Detector
Weight | 13 kg | 20 kg |
| Pixel Array | 2816x2816 | 2688 x2688 |
| Active Area | 43cm×43cm | 43cm×43cm |
| Pixel Pitch | 154µm | 160µm |
| ADC
Digitization | 16 bit | 14 bit |
| Power
Consumption | 36 W | Max.200 VA |75% RH
| Modulation
Transfer
Function
(MTF) | 1 lp/mm (70±3)%
2 lp/mm (42±3)%
3 lp/mm (23±3)% | 1 lp/mm 68%
2 lp/mm 38%
3 lp/mm 18% |
| Detective
Quantum
Efficiency
(DQE) | DQE at 5 µGy
0 lp/mm (63±3)%
1 lp/mm (45±3)%
2 lp/mm (33±3)%
3 lp/mm (20±3)% | DQE at 5 mR
0 lp/mm 37%
I lp/mm 34%
2 lp/mm 24%
3 lp/mm 12% |
| Power
Supply | Voltage: 100-250 VAC
Frequency: 50/60 Hz | Voltage: 100V, 120V, 230/240 V
Frequency: 50/60 Hz |
| Operating
Condition | Temperature: 5 ~ 35°C
Relative humidity: 30
Air pressure: 700hPa1060hPa | Temperature: 535°C
Relative humidity: 3075%90%RH
Air pressure: 700hPa 1060hPa |55 °C
| Storage
Condition | Temperature: -20
Relative humidity: 10
Air pressure: 700hPa1060hPa | Temperature: -3060 °C
Relative humidity: 10~60%
Air pressure: 700hPa ~1060hPa |
7. Technological Characteristics [21 CFR 807.92(a)(6)]
5
6
8. System requirements to operate with other radiographic system components
-
- 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.
- Application Program Interface (API) for system integration manufacturer
CPU: Intel (R) Core (TM) 2 Duo, 2.93GHz or above
RAM: 2 GB or higher
Hard disk: 160 GB or higher
Monitor: 1280 x 1024 or higher
OS: Windows XP or Windows 7
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.
- X-ray exposure mode
CareView 1800R supported typical sync mode contains external sync, manual 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)]
-
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. Section 201.7.2.7, 201.7.9.1, 201.7.9.2.1.103 and 203.4.1 of IEC 60601-2-54 were also conducted. -
A Nonclinical considerations
The following non-clinical studies have been performed and the results have shown that the CareView 1800R X-ray flat panel detector is substantially equivalent to the predicate devices on the Market (CXDI-40EG).
7
-Detective quantum efficiency (DQE), Quantum limited performance, Modulation transfer function (MTF), Effects of aliasing, Sensitivity linearity, Lag(Erasure thoroughness), Change in detection sensitivity, Dose requirement and reciprocity changes, Stability of device characteristics with time, Uniformity of device characteristic, Noise power spectrum(NPS), Spatial resolution, Image Acquisition time, & Black level
- A Clinical considerations
A concurrence study of 30 clinical images was conducted to compare the performance of the CareView 1800R to that of the predicate device (K050987).
Clinical images were provided; these images were not necessary to establish substantial equivalence based on the superior performance in comparison to the predicate based on laboratory testing and based on the use of a detector scintillator material that is already on the marketplace; however, they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
There was no significant difference between the images of the CareView 1800R and those of the predicate device.
10. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Druq and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, the CareView 1800R X-ray flat panel detector is substantially equivalent to predicate device CXDI-40EG (K050987). Both propose and predicate devices are same or very similar in the intended use, the design principle, the applicable standards and specification. Some characteristics, for example, the detector size, pixel pitch, weight and ADC digitization, X-ray absorber, storage condition are different. However the test reports in this submission documents provide demonstration that these differences do not raise any new questions of safety and effectiveness. Therefore, CareRay Digital Medical System Co., Ltd. concludes the CareView 1800R X-ray flat panel detector is substantially equivalent with the predicate device CXDI-40EG (K050987) of Canon Inc.