(20 days)
Not Found
No
The description focuses on the hardware components and basic image acquisition process, with no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies.
No
The device is a diagnostic imaging solution, specifically an X-ray detector, used for providing images for diagnosis, not for treating a condition.
Yes
The device is described as being "indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy" and "intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures." It is designed to capture X-ray images for diagnostic purposes.
No
The device description clearly states it is a "cassette size digital X-ray flat panel detector" and describes its physical components and how it converts X-ray photons into electrical signals, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "providing general radiographic diagnosis of human anatomy." This involves imaging the internal structures of the body using X-rays.
- Device Description: The device is a digital X-ray flat panel detector that captures X-ray images.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not interact with or analyze such specimens.
The device described is a medical imaging device used for diagnostic purposes, but it falls under the category of radiological devices, not IVDs.
N/A
Intended Use / Indications for Use
The CareView 1500C/ CareView 1500L 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 generalpurpose 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 1500C/ CareView 1500L is a kind of cassette size digital X-ray flat panel detectors which have 434mmx355mm imaging area. The device communicates by wired communication feature (Giga-bit Ethernet communication mode by connecting the power box).
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.
Generally, CareView 1500C/CareView 1500L is the same as the cleared product, CareView 1500Cw except the following aspects:
- Based on CareView 1500Cw, the WIFI wireless communication function is cut in CareView 1500C and CareView 1500L. Accordingly, the internal WIFI communication circuit module is removed.
- Based on CareView 1500Cw, the lithium battery pack is removed. So the power supply mode is simplified. In CareView 1500Cw, both power box and the battery pack can supply power, while in CareView 1500C and CareView 1500L, only the power box can supply power.
- Based on CareView 1500Cw, CareView 1500C and CareView 1500L removed the power button. Because lithium battery is removed and there is one power switch on power box, so the power button on detector is unnecessary.
- Compare with CareView 1500Cw and CareView 1500C, the handle is removed on CareView 1500L. Accordingly, the enclosure of the bottom is changed. The final enclosure is simpler and more compact.
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)
Electrical safety and EMC testing was performed. All test results are satisfactory.
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 an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2015
CareRay Digital Medical Systems Co., Ltd. % Ms. Leilei Li Engineer A2-201/B3-501, Biobay, 218 Xinghu Street, SuZhou Industrial Park SuZhou, Jiangsu 215123 P. R. CHINA
Re: K153058
Trade/Device Name: CareView 1500C/CareView 1500L X-ray Flat Panel Detectors Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 14, 2015 Received: October 21, 2015
Dear Ms. 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. 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,
Robert Oels
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) K153058
Device Name
CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
Indications for Use (Describe)
The CareView 1500C/ CareView 1500L 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 generalpurpose 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
4
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
Oct. 14, 2015
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: | 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 1500C/ CareView 1500L |
| 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 |
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| Regulatory Class: | Class II |
|---|---|
| Product Code: | MQB |
| FDA 510(k) #: | K150929 |
5. Description of the Device [21 CFR 807.92(a)(4)]
CareView 1500C/ CareView 1500L is a kind of cassette size digital X-ray flat panel detectors which have 434mmx355mm imaging area. The device communicates by wired communication feature (Giga-bit Ethernet communication mode by connecting the power box).
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.
Generally, CareView 1500C/CareView 1500L is the same as the cleared product, CareView 1500Cw except the following aspects:
-
- Based on CareView 1500Cw, the WIFI wireless communication function is cut in CareView 1500C and CareView 1500L. Accordingly, the internal WIFI communication circuit module is removed.
-
- Based on CareView 1500Cw, the lithium battery pack is removed. So the power supply mode is simplified. In CareView 1500Cw, both power box and the battery pack can supply power, while in CareView 1500C and CareView 1500L, only the power box can supply power.
-
- Based on CareView 1500Cw, CareView 1500C and CareView 1500L removed the power button. Because lithium battery is removed and there is one power switch on power box, so the power button on detector is unnecessary.
- Compare with CareView 1500Cw and CareView 1500C, the handle is removed on 4) CareView 1500L. Accordingly, the enclosure of the bottom is changed. The final enclosure is simpler and more compact.
6. Intended Use [21 CFR 807.92(a)(5)]
The CareView 1500C/ CareView 1500L 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.
6
| Item | Proposed Device:
X-ray Flat Panel Detectors | Predicate Device:
X-ray Flat Panel Detectors |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | To be assigned | K150929 |
| Model | CareView 1500C/ CareView 1500L | 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 |
| Installation Type | Wired, Cassette | Wireless, Portable |
| Readout
Mechanism | Thin Film Transistor | Thin Film Transistor |
| Image Matrix Size | 2304 × 2816 pixels | 2304 × 2816 pixels |
| Pixel Pitch | 154µm | 154µm |
| Effective Imaging
Area | 355 mm × 434 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.1 A
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. 24 W | Max. 36 W |
| Communications
● Wired
● Wireless | Gigabit Ethernet
/ | 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 | 384 mm × 460 mm × 15 mm | 384 mm x 460 mm x 15 mm |
| Operation | Temperature: +5 ~ +35 ℃
Humidity: 30 ~ 75%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106
kPa | 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 | Temperature: -20 ~ +55 ℃
Humidity: 10 ~ 90%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106
kPa
Altitude: Max. 3000 meters |
7. Technological Characteristics [21 CFR 807.92(a)(6)]
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
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.
CareView 1500C supported typical sync mode contains soft sync, manual sync and auto sync containing FFAED mode.
CareView 1500L 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 1500C/ CareView 1500L) and predicate device (CareView 1500Cw) share most of primary product specifications including intended use, technology,
8
material, and imaging principle, etc. Difference lies in the means of connectivity and power supply. While predicate device supports both wired and wireless connections, the proposed devices provide only a wired connection between the detector and PC. While predicate device supports both internal and external powered, the proposed devices provide only external powered.
The difference of connectivity and power supply 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 CareView 1500C/ CareView 1500L X-ray flat panel detector is substantially equivalent to predicate device CareView 1500Cw (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 connectivity and power supply 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 1500C/ CareView 1500L X-ray flat panel detector is substantially equivalent with the predicate device CareView 1500Cw (K150929).