(29 days)
Not Found
No
The summary describes a standard digital X-ray detector that converts X-ray photons into digital images. There is no mention of AI, ML, or any advanced image processing that would suggest the use of these technologies. The description focuses on the hardware and basic image acquisition process.
No.
The device is described as an X-ray detector intended for diagnostic imaging, not for treating or alleviating a condition.
Yes
The device is described as "indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy," and "It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures," which clearly states its use for diagnosis.
No
The device description clearly states it is a "wireless, portable digital X-ray flat panel detector" and describes its physical components and how it converts X-ray photons into electrical signals and then digital values. This indicates it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CareView 1800Cw detector is a digital X-ray flat panel detector. Its function is to capture X-ray images of the human anatomy. It does not analyze biological samples.
- Intended Use: The intended use is for "general radiographic diagnosis of human anatomy," which involves imaging the internal structures of the body using X-rays. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro.
Therefore, the device's purpose and mechanism of action clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The CareView 1800Cw 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
CareView 1800Cw is a kind of wireless, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Human anatomy (general radiographic diagnosis)
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.
A Nonclinical and clinical considerations
The proposed device (CareView 1800Cw) 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. While the predicate detector has a rectangular shape of 355 mm X 434 mm, the subject device is larger and square, measuring 433.5 mm X 433.5 mm. The pixel size stays unchanged from the predicate detector.
The differences of mechanical structure don't affect the technological parameters and clinical images.
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 stylized depiction of a bird or eagle in flight, composed of three overlapping profiles facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2017
CareRay Digital Medical Systems Co., Ltd. % Mr. Wei Xu Manager, Regulation Department B3-501, Biobay, 218 Xinghu Street, SuZhou Industrial Park SuZhou, 215123 Jiangsu CHINA
Re: K172581
Trade/Device Name: Careview 1800Cw X-ray Flat Panel Detectors Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 29, 2017 Received: August 28, 2017
Dear Mr. Xu:
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 devicerelated 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/ResourcesforYou/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
2
Indications for Use
510(k) Number (if known) K172581
Device Name
CareView 1800Cw X-ray Flat Panel Detectors
Indications for Use (Describe)
The CareView 1800Cw 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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3
510(k) Summary
4
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
July 29, 2017
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: | X-ray Flat Panel Detectors |
|---|---|
| Model Name: | CareView 1800Cw |
| 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 |
| Model Name: | CareView 1500Cw |
| Classification Name: | Stationary X-ray system |
| Regulation Number: | 21 CFR 892.1680 |
Page1of5
5
| Regulatory Class: | Class II |
|---|---|
| Product Code: | MQB |
| FDA 510(k) #: | K150929 |
5. Description of the Device [21 CFR 807.92(a)(4)]
CareView 1800Cw is a kind of wireless, 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.
6. Intended Use [21 CFR 807.92(a)(5)]
The CareView 1800Cw 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.
| Item | Proposed Device:
X-ray Flat Panel Detectors | Predicate Device:
X-ray Flat Panel Detectors |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | To be assigned | K150929 |
| Model | CareView 1800Cw | 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 ,Wired, Portable | Wireless, Wired, Portable |
| ReadoutMechanis
m | Thin Film Transistor | Thin Film Transistor |
| Image Matrix Size | 2816 × 2816 pixels | 2304 × 2816 pixels |
| Pixel Pitch | 154μm | 154μm |
| Effective Imaging
Area | 433.5 mm × 433.5 mm | 355 mm × 434 mm |
| Grayscale | 16 bit, 65536 grayscale | 16 bit, 65536 grayscale |
| Spatial Resolution | Min. 3.3 line pair/mm | Min. 3.3 line pair/mm |
| Rated
Power
Supply
Wired
Wireless | DC 24 V, Max.2A
Powered by the battery pack
Powered by the power box using
interface cable | DC +24 V, Max.1.5 A
Powered by the power box
using interface cable
Powered by the battery pack |
| Power
Consumption | Max. 48 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 | 460mm × 460mm × 15mm | 384 mm x 460 mm x 15 mm |
| Operation | Temperature: +5 ~ +35 ℃
Humidity: 30 ~ 75%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106
kPa
Altitude: Max.3000 meters | Temperature: +5 ~ +35 ℃
Humidity: 30 ~ 75%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106
kPa
Altitude: Max.3000 meters |
| Storage and
transportation | Temperature: -20 ~ +55 ℃
Humidity: 10 ~ 90%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106
kPa
Altitude: Max.3000 meters | Temperature: -20 ~ +55 ℃
Humidity: 10 ~ 90%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106
kPa
Altitude: Max.3000 meters |
| Intended Use | The CareView 1800Cw 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 CareView 1500Cw 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. |
| MTF | ~70%..........(@ 1lp/mm)
~40%..........(@ 2lp/mm)
~22%..........(@ 3lp/mm) | ~70%..........(@ 1lp/mm)
~40%..........(@ 2lp/mm)
~22%..........(@ 3lp/mm) |
| DQE | (@RQA5, 30μGy)
~65%..........(@ 0lp/mm)
~20%..........(@ 3lp/mm) | (@RQA5, 30μGy)
~65%..........(@ 0lp/mm)
~20%..........(@ 3lp/mm) |
| Dynamic range | ~82 dB | ~82 dB |
| System Software | API V4.5.0 (NDT V3.5.5) | API V4.5.0 (NDT V3.5.5) |
7. Technological Characteristics [21 CFR 807.92(a)(6)]
6
7
| Version | ||
|---|---|---|
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
thespecifications described above. If you have questions regarding the compatibility issue for othergenerators, please contact your distributor or CareRay.
-
- ApplicationProgram 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: 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 3) X-ray exposure mode
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.
- ApplicationProgram 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: 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 3) X-ray exposure mode
CareView 1800Cw 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 Nonclinical and clinical considerations
The proposed device (CareView 1800Cw) and predicate device (CareView 1500Cw) share most of primary product specifications including intended use, technology, material, and
8
imaging principle, etc. Difference lies in the mechanical structure. While the predicate detector has a rectangular shape of 355 mm X 434 mm, the subject device is larger and square, measuring 433.5 mm X 433.5 mm. The pixel size stays unchanged from the predicate detector.
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, the CareView1800Cw X-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 provide demonstration that these differences do not raise any new questions of safety an deffectiveness. Therefore, CareRay Digital Medical System Co., Ltd. concludes the CareView1800Cw X-ray flat panel detector is substantially equivalent with the predicate device CareView1500Cw (K150929).