(31 days)
Not Found
No
The summary describes a standard digital X-ray detector and its technical specifications. There is no mention of AI, ML, or any advanced image processing that would suggest the use of these technologies. The software version mentioned appears to be related to the device's API and not indicative of AI/ML capabilities.
No
The device is described as a 'digital imaging solution designed for providing general radiographic diagnosis of human anatomy', indicating it is for diagnostic purposes, not therapeutic treatment.
Yes
The text states that the device is "indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy." This directly implies its use in diagnosing medical conditions.
No
The device description clearly describes a physical hardware component (digital X-ray flat panel detector) that intercepts X-ray photons and converts them into electrical signals and then digital values for display. While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "digital imaging solution designed for providing general radiographic diagnosis of human anatomy." This involves imaging the internal structures of the body using X-rays.
- Device Description: The description details how the device captures X-ray photons and converts them into digital images for display. This is consistent with medical imaging equipment used for diagnosis based on visual interpretation of anatomical structures.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, disease, or condition. This device does not interact with or analyze such specimens.
Therefore, the CareView 750Cw/750C detector falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The CareView 750Cw/750C 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
Device Description
CareView 750Cw/750C is a kind of wireless(750C does not have wireless, it has only wired fuction.) portable digital X-ray flat panel detectors which have 244 mm x 307 mm imaging area. The device communicates by not only the wireless communication but also wired communication feature (Giga-bit Ethernet communication mode by connecting the power box) optionally.
The device intercepts X-ray photons and then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. After the electrical signals are generated, it is converted to a digital value and an image will be displayed on the monitor.
The detector should be integrated with an operating PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic.
The detector can't provide feedback to the generator to terminate the x-ray exposure.
System Software Version is API V4.5.0 (NDT V3.5.5) that based on V4.2.0. But V4.5.0 is more powerful than old version. Please see the comparison of section 7 Technological Characteristics.
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)
Performance Testing: The performance testing items included Offset Stability, Dark Noise, Spatial Resolution, Low-contrast Resolution, Dynamic Range&Sensitivity, Lag, Ghost, MTF and DQE etc. These testing conducted in accordance with IEC61223-3-1, IEC 6220-1 and FDA's SSXI guidance document (Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices).
Key results: All test results are satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 1, 2016S
CareRay Digital Medical System Co., Ltd. % Mr. Xu Wei Manager B3-501, Biobay, 218 Xinghu Street SuZhou Industrial Park SuZhou, Jiangsu 215123 P. R. CHINA
Re: K163019
Trade/Device Name: CareView 750Cw/750C X-ray Flat Panel Detectors Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: July 1, 2016 Received: November 3, 2016
Dear Mr. 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. 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.
Michael D. O'Hara
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
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Indications for Use
510(k) Number (if known) K163019
Device Name
CareView 750Cw/750C X-ray Flat Panel Detectors
Indications for Use (Describe)
The CareView 750Cw/750C 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 Sub |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
4
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
Aug.01, 2016
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Company Name: | CareRay Digital Medical System 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: | CareView750Cw/750C X-ray Flat Panel Detectors |
|---|---|
| (hereinafter: CareView750Cw/750C or | |
| CareView750Cw/750C detector , apply to the all submission | |
| documents ) | |
| Model Name: | CareView 750Cw/750C |
| 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: CareRay Digital Medical System Co., Ltd. Trade Name: X-ray Flat Panel Detectors
5
| Model Name: | CareView 1500Cw |
|---|---|
| Classification Name: | Stationary X-ray system |
| Regulation Number: | 21 CFR 892.1680 |
| Regulatory Class: | Class II |
| Product Code: | MQB |
| FDA 510(k) #: | K150929 |
5. Description of the Device [21 CFR 807.92(a)(4)]
CareView 750Cw/750C is a kind of wireless(750C does not have wireless, it has only wired fuction.) portable digital X-ray flat panel detectors which have 244 mm x 307 mm imaging area. The device communicates by not only the wireless communication but also wired communication feature (Giga-bit Ethernet communication mode by connecting the power box) optionally.
The device intercepts X-ray photons and then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. After the electrical signals are generated, it is converted to a digital value and an image will be displayed on the monitor.
The detector should be integrated with an operating PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic.
The detector can't provide feedback to the generator to terminate the x-ray exposure.
System Software Version is API V4.5.0 (NDT V3.5.5) that based on V4.2.0. But V4.5.0 is more powerful than old version. Please see the comparison of section 7 Technological Characteristics.
6. Intended Use [21 CFR 807.92(a)(5)]
The CareView 750Cw/750C detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographicfilm/screen systems in all general-purpose diagnostic procedures.This product is not intended for mammography applications.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Item | Proposed Device:
CareView750Cw/750C X-ray Flat
Panel Detectors | Predicate Device:
CareView 1500Cw X-ray Flat
Panel Detectors |
|---------------|----------------------------------------------------------------------|--------------------------------------------------------------------|
| 510(K) Number | K163019 | K150929 |
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| Model | CareView 750Cw/750C | CareView 1500Cw | ||
|---|---|---|---|---|
| Classification Name | Stationary X-ray system | Stationary X-ray system | ||
| Product Code | MQB | MQB | ||
| Regulation Number | 892.1680 | 892.1680 | ||
| Panel | Radiology | Radiology | ||
| Class | II | II | ||
| X-ray Absorber | Csl Scintillator | Csl Scintillator | ||
| InstallationType | Wireless (except 750C) ,Wired, Portable | Wireless, Wired, Portable | ||
| ReadoutMechanism | Thin Film Transistor | Thin Film Transistor | ||
| Image Matrix Size | 2048 x 2560 pixels | 2304 x 2816 pixels | ||
| Pixel Pitch | 120μm | 154μm | ||
| Effective Imaging Area | 244 mm x 307 mm | 355 mm x 434 mm | ||
| Grayscale | 16 bit, 65536 grayscale | 16 bit, 65536 grayscale | ||
| Spatial Resolution | Min. 4.2 line pair/mm | Min. 3.3 line pair/mm | ||
| Rated Power Supply Wired Wireless | DC +24 V, Max. 1.3A | |||
| Powered by the switching power supply using interface cable | ||||
| Powered by the battery pack(except 750C) | DC +24 V, Max.1.5 A | |||
| Powered by the power box using interface cable | ||||
| Powered by the battery pack | ||||
| Power Consumption | Max. 31.2 W | Max. 36 W | ||
| Communications Wired Wireless | Gigabit Ethernet | |||
| IEEE 802.11a/b/g/n (2.4 / 5 GHz) | Gigabit Ethernet | |||
| IEEE 802.11a/b/g/n (2.4 / 5 GHz) | ||||
| Imaging Plate | Carbon Fiber Plate | Carbon Fiber Plate | ||
| Cooling | Air cooling | Air cooling | ||
| Dimensions | 282mm x 333mm x 15mm | 384 mm x 460 mm x 15 mm | ||
| Operation | Temperature: +5 ~ +35°C | |||
| Humidity: 30 ~ 75% (Non-Condensing) | ||||
| Atmospheric pressure: 70 ~ 106 kPa | ||||
| Altitude: Max.3000 meters | Temperature: +5 ~ +35°C | |||
| Humidity: 30 ~ 75% (Non-Condensing) | ||||
| Atmospheric pressure: 70 ~ 106 kPa | ||||
| Altitude: Max.3000 meters | ||||
| Storage and transportation | Temperature: -20 ~ +55°C | |||
| Humidity: 10 ~ 90% (Non-Condensing) | ||||
| Atmospheric pressure: 70 ~ 106 kPa | ||||
| Altitude: Max.3000 meters | Temperature: -20 ~ +55°C | |||
| Humidity: 10 ~ 90% (Non-Condensing) | ||||
| Atmospheric pressure: 70 ~ 106 kPa | ||||
| Altitude: Max.3000 meters | ||||
| Intended Use | The CareView 750Cw/750C detector is indicated for digital imaging solution designed for providing general radiographic | The CareView 1500Cw detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of | ||
| 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. | ||||
| MTF | ~70%..........(@ 1lp/mm) | |||
| ~40%..........(@ 2lp/mm) | ||||
| ~22%..........(@ 3lp/mm) | ~70%..........(@ 1lp/mm) | |||
| ~40%..........(@ 2lp/mm) | ||||
| ~22%..........(@ 3lp/mm) | ||||
| DQE | (@RQA5, 30 $\mu$ Gy) | |||
| ~65%..........(@ 0lp/mm) | ||||
| ~20%..........(@ 3lp/mm) | (@RQA5, 30 $\mu$ Gy) | |||
| ~65%..........(@ 0lp/mm) | ||||
| ~20%..........(@ 3lp/mm) | ||||
| Dynamic range | ~82 dB | ~82 dB | ||
| System Software | ||||
| Version | API V4.5.0 (NDT V3.5.5) |
Based on V4.2.0, V4.5.0 includes
the following new enhancements:
CarerayTouch handswitch
Resume broken downloads
One-shot calibration
Small-window AED | API V4.2.0 (NDT V3.4.0) | | |
7
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
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The synchronous connection mode is the signal transfer modebetween the X-ray generator which sends the X-ray and the detector which receives the X-ray.
CareView 750Cw/750C supported typical sync mode contains external sync, soft sync, manual sync and auto sync containing FFAED 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 Performance Testing
The performance testing items included Offset Stability, Dark Noise, Spatial Resolution, Low-contrast Resolution, Dynamic Range&Sensitivity, Lag, Ghost, MTF and DQE etc. These testing conducted in accordance with IEC61223-3-1, IEC 6220-1 and FDA's SSXI guidance document (Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices). The RF module that provided by supplier is in compliance with ANSI C63.4-2003 and 47 CFR FCC Part 15 Subpart C and get FCC ID. -
A Nonclinical and clinical considerations
The proposed device (CareView 750Cw/750C) and predicate device (CareView 1500Cw) share most of primary product specifications including intended use, technology, material, and imaging principle, etc. Difference lies in the mechanical structure.
The differences of mechanical structure 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,theCareView750Cw/750CX-ray flat panel detector is substantially equivalent to predicate deviceCareView1500Cw (K150929). Both propose and predicate devices are same in the intended use, the design principle, the applicable standards and specification. Some characteristics, for example,the mechanical structure are different. However the test reports in this submission documents
9
provide demonstration that these differences do not raise any new questions of safety an deffectiveness. Therefore, CareRay Digital Medical System Co., Ltd. concludes the CareView750Cw/750C X-ray flat panel detector is substantially equivalent with the predicate device CareView1500Cw (K150929).