(141 days)
Not Found
No
The description focuses on the hardware and basic image processing (preprocess images) of a digital X-ray detector. There is no mention of AI, ML, or any related concepts like training or test sets for algorithmic performance.
No.
This device is an X-ray detector used for imaging and diagnosis, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed for providing general radiographic diagnosis of human anatomy."
No
The device description clearly states it is a "radiography X-ray flat panel detector" and describes its physical components (scintillator, photo detectors) and wired connection, indicating it is a hardware device.
Based on the provided information, the CareView 3600RF detector is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states "digital imaging solution designed for providing general radiographic diagnosis of human anatomy." This involves imaging the human body directly, which is an in vivo process, not in vitro (meaning "in glass" or outside the body).
- Device Description: The description details how the device intercepts X-ray photons and converts them into electrical signals to create an image on a monitor. This is consistent with medical imaging equipment used on living patients.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The description of the CareView 3600RF does not mention any interaction with biological specimens.
Therefore, the CareView 3600RF detector is a medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CareView 3600RF 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 (comma separated list FDA assigned to the subject device)
MQB
Device Description
The CareView 3600RF detector is a class of radiography X-ray flat panel detector that has an imaging area of 867.5mm×433.1mm. The detector communicates by a wired connection (Giga-bit Ethernet communication mode).
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 to digitize X-ray images and transfer radiography diagnostics. The x-ray generator, an essential part of a full x-ray system, is not part of the subject medical 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
-
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 non-clinical studies have been performed and the results have shown that the CareView 3600RF X-ray flat panel detectors is substantially equivalent to the predicate device on the market (Mars1417V-PSI Wireless Digital Flat Panel Detector, K161730):
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
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
CareRay Digital Medical Tehnology Co., Ltd. % Leilei Li RA Manager A2-201/B3-501, Biobay, 218 Xinghu Street SuZhou Industrial Park Suzhou, Jiangsu 215123 CHINA
February 19, 2021
Re: K202995
Trade/Device Name: X-ray Flat Panel Detectors/CareView 3600RF Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: January 15, 2021 Received: January 22, 2021
Dear Leilei Li:
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 medical devices and radiation-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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202995
Device Name X-ray Flat Panel Detectors/CareView 3600RF
Indications for Use (Describe)
The CareView 3600RF 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-purposic 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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3
006_510(k) Summary
4
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
Sep. 28, 2020
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: | Ms. Li | |
| Phone Number: | (86) 512-86860288 | |
| Fax Number: | (86) 512-86860388 | |
| E-mail: | ll.li@careray.com |
3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]
| Trade Name: | X-ray Flat Panel Detectors |
|---|---|
| Model Name: | CareView 3600RF |
| 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: | iRay Technology (Shanghai) Ltd. |
|---|---|
| Trade Name: | Wireless Digital Flat Panel Detector |
| Model Name: | Mars1417V-PSI |
| Classification Name: | Stationary X-ray system |
| Regulation Number: | 21 CFR 892.1680 |
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| Regulatory Class: | Class II |
|---|---|
| Product Code: | MQB |
| FDA 510(k) #: | K161730 |
5. Description of the Device [21 CFR 807.92(a)(4)]
The CareView 3600RF detector is a class of radiography X-ray flat panel detector that has an imaging area of 867.5mm×433.1mm. The detector communicates by a wired connection (Giga-bit Ethernet communication mode).
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 to digitize X-ray images and transfer radiography diagnostics. The x-ray generator, an essential part of a full x-ray system, is not part of the subject medical device.
6. Intended Use [21 CFR 807.92(a)(5)]
The CareView 3600RF 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.
| Item | Proposed Device:
X-ray Flat Panel Detectors | Predicate Device:
Wireless Digital Flat Panel
Detector | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | To be assigned | K161730 | | |
| Model | CareView 3600RF | Mars1417V-PSI | | |
| Intended Use | The CareView 3600RF 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. | Mars1417V-PSI Wireless Digital
Flat Panel 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 or
dental 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 | GOS Scintillator | GOS Scintillator | | |
| Installation Type | Wired | Wireless, Portable | | |
| Readout
Mechanism | Thin Film Transistor | Thin Film Transistor | | |
| Image Matrix Size | 5632 x 2816 pixels | 2304 x 2800 pixels | | |
| Pixel Pitch | 154μm | 150μm | | |
| Effective Imaging
Area | 867.5 mm x 433.1 mm | 355 mm x 434 mm | | |
| Grayscale | 16 bit | 14 bit | | |
| Spatial Resolution | 3.4 lp/mm | 3.4 lp/mm | | |
| MTF | 75%..........(@ 0.5lp/mm)
50%..........(@ 1lp/mm) | 0.75..........(@ 0.5lp/mm) | | |
| DQE | (@RQA5, 3.2µGy)
28%..........(@ 0.5lp/mm)
20%..........(@ 1lp/mm) | (@RQA5, 3.2µGy)
0.27..........(@ 0.5lp/mm) | | |
| Power
Consumption | ~50W | Max. 13W | | |
| Communications | Gigabit Ethernet | Wired: Gigabit Ethernet
Wireless: IEEE 802.11a/b/g/n
(2.4 GHz/ 5 GHz) | | |
| Imaging Plate | Carbon Fiber Plate | Carbon Fiber Plate | | |
| Cooling | Air cooling | Air cooling | | |
| Dimensions | 916.9mm x 486.4mm x 42.8mm | 384mm x 460mm x 15mm | | |
| Operation | Temperature: +10 ~ +40°C
Humidity: 30 ~ 75% RH
(Non-Condensing)
Atmospheric pressure: 700 ~ 1060 hPa
Altitude: Max. 3000 meters | Temperature: +5 ~ +35°C
Humidity: 30 ~ 75% RH
(Non-Condensing)
Atmospheric pressure: 700 ~ 1060 hPa
Altitude: Max. 3000 meters | | |
| | Storage and
transportation | Temperature: -20 ~ +55°C
Humidity: 10 ~ 90% RH
(Non-Condensing)
Atmospheric pressure: 700 ~ 1060 hPa
Altitude: Max. 3000 meters | Temperature: -20 ~ +55°C
Humidity: 10 ~ 90% RH
(Non-Condensing)
Atmospheric pressure: 700 ~ 1060 hPa
| |
| | | Software | CareRay software provides a set
of predefined APIs (Application
Programming Interfaces), an
adapter layer between a
CareView 3600RF detector and
an upstream program on the
client side, commonly known as
DROC (Digital Radiography
Operator Console).
DROC communicates with the
CareRay detectors via APIs. In | iRay DR
The iRay DR used for getting Digital
X-ray radiography images from the
flat panel detectors. iRay DR is
used to handle the DICOM protocol
(DICOM 3.0),
iRay DR is responsible for the DR
equipment management,
acquisition and processing
functions to provides patient |
| | | | | general, APIs are provided in the
form of DLL (Dynamic-Link
Libraries) files. The upstream
program imports these DLL files
and calls relevant API
commands to manipulate a
CareView 3600RF
detector—query status, select
application mode, calibrate
detector, acquire images, and
preprocess images—without
caring about the implementation
details of the algorithm or
workflow under the hood. |
| Utilized FDA
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. Guidance for the Content of
Premarket Submissions for
Software Contained in
Medical Devices
5. 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 | |
7. Technological Characteristics [21 CFR 807.92(a)(6)]
6
7
8. System requirements to operate with other radiographic system components
The submitted medical device is the CareView 3600RF digital detector. The other x-ray system components referred below are for information purpose only.
- Recommended Generator Specification:
Energy range: 40~150kVp
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
8
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 3) 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.
- 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 3) X-ray exposure mode
CareView 3600RF supported 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 non-clinical studies have been performed and the results have shown that the CareView 3600RF X-ray flat panel detectors is substantially equivalent to the predicate device on the market (Mars1417V-PSI Wireless Digital Flat Panel Detector, K161730):
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
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 CareView 3600RF X-ray flat panel detector is substantially equivalent to predicate device Mars1417V-PSI Wireless
9
Digital Flat Panel Detector (K161730). 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 CareView 3600RF X-ray flat panel detector is substantially equivalent with the predicate device with regard to safety and effectiveness..