(62 days)
The CareView 1800RF 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 1800RF detector is a class of radiography X-ray flat panel detector that has an imaging area of 434 mm × 434 mm. 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.
The CareView 1800RF detector can be used for dynamic imaging (fluoroscopy).
The provided document is a 510(k) premarket notification for the CareView 1800RF X-ray Flat Panel Detector. It aims to demonstrate substantial equivalence to a predicate device, CareView 1800Le (K193173), and a reference device, 1717FCC (K210985).
The document states that clinical images are not necessary for the current submission, and that successful results of bench testing should be sufficient to show substantial equivalence for the subject device. This implies that the acceptance criteria are primarily based on non-clinical performance benchmarks and that no clinical study involving human subjects or expert readers was conducted for this submission to prove device performance against acceptance criteria in a clinical context.
Therefore, many of the requested details about acceptance criteria derived from clinical studies, expert involvement, and ground truth establishment cannot be extracted from this document because such studies were explicitly stated as not necessary for this 510(k) submission.
However, the document does provide information regarding the technical specifications of the device and its predicate/reference devices, which implicitly serve as performance benchmarks for substantial equivalence based on bench testing.
Here's a breakdown of the information that can be extracted:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study with explicit acceptance criteria for diagnostic performance is provided, the closest relevant information is the comparison of technical specifications between the proposed device and its predicate/reference devices. The "acceptance criteria" here are essentially "comparable technical specifications."
| Item | Acceptance Criteria (Predicate/Reference) | Reported Device Performance (CareView 1800RF) |
|---|---|---|
| Predicate Device (CareView 1800Le - K193173) | ||
| Intended Use | General radiographic diagnosis of human anatomy, replace radiographic film/screen systems, not for mammography. | General radiographic diagnosis of human anatomy, replace radiographic film/screen systems, not for mammography. (Same) |
| Classification Name | Stationary X-ray system | Stationary X-ray system (Same) |
| Regulation Number | 892.1680 | 892.1680 (Same) |
| Panel | Radiology | Radiology (Same) |
| Class | II | II (Same) |
| X-ray Absorber | CsI Scintillator | CsI Scintillator (Same) |
| Installation Type | Wired, Cassette | Wired, Cassette (Same) |
| Readout Mechanism | Thin Film Transistor | Thin Film Transistor (Same) |
| Image Matrix Size | 3072 × 3072 pixels | 2816 × 2816 pixels |
| Pixel Pitch | 140µm | 154µm |
| Effective Imaging Area | 430 mm × 430 mm | 434 mm × 434 mm |
| Grayscale | 16 bit, 65536 grayscale | 16 bit, 65536 grayscale (Same) |
| Spatial Resolution | 3.57 line pair/mm | 3.3 line pair/mm |
| MTF (@ 1lp/mm) | ≥63% | ≥60% |
| MTF (@ 2lp/mm) | ≥35% | ≥30% |
| MTF (@ 3lp/mm) | ≥17% | ≥17% (Same) |
| DQE (@RQA5, 1lp/mm) | ≥62% (at 30µGy) / ≥45% (at 1µGy) | ≥55% (at 2µGy) |
| DQE (@RQA5, 3lp/mm) | ≥17% (at 30µGy) | ≥20% (at 2µGy) |
| Rated Power Supply | DC +24 V, Max.1 A | DC 24 V, Max.1.25 A |
| Network interface | Gigabit Ethernet | Gigabit Ethernet (Same) |
| Imaging Plate | Carbon Fiber Plate | Carbon Fiber Plate (Same) |
| Cooling | Air cooling | Air cooling (Same) |
| Dimensions | 460 mm x 460 mm x 15 mm | 460mm x 460mm x 28mm |
| Operation Temperature | +5 ~ +35°C | +10 ~ +40°C |
| Operation Humidity | 30 ~ 75% (Non-Condensing) | 30 ~ 75% (Non-Condensing) (Same) |
| Operation Atmospheric Pressure | 700 ~ 1060 hPa | 700 ~ 1060 hPa (Same) |
| Reference Device (1717FCC - K210985) | ||
| Intended Use | Digital imaging solution for general radiographic system for human anatomy, replace film or screen based radiographic systems, not for mammography. | General radiographic diagnosis of human anatomy, replace radiographic film/screen systems, not for mammography. (Similar) |
| Product Code | MQB, JAA | MQB, JAA (Same) |
| Detector Type | Amorphous Silicon (a-Si) TFT + PIN type photodiode / IGZO TFT + PIN type photodiode | TFT (Implied a-Si from predicate) |
| Image Matrix Size | 3000 x 3000 pixels | 2816 x 2816 pixels |
| Pixel Pitch | 140µm | 154µm |
| Effective Imaging Area | 17 x 17 inches | 434 mm x 434 mm (approx. 17.1 x 17.1 inches) |
| Grayscale | 14/16 bit | 16 bit |
| Spatial Resolution | 3.5 lp/mm | 3.3 lp/mm |
| Pixel matrix binning (1x1) | 3000 x 3000 | 2816 x 2816 |
| Frame rate (GigE, 1x1) | 6 fps | 4 fps |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The submission explicitly states "Clinical images are not necessary for the current submission. Successful results of bench testing should be sufficient...". Therefore, no clinical test set was used. The substantial equivalence is based on bench testing for electrical safety, EMC, and comparison of technical specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No clinical test set or human evaluation study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The device is a flat panel detector, not an AI-powered diagnostic tool. Furthermore, no clinical studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a flat panel detector, not an algorithm, and no clinical studies were done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No clinical studies were done, so no ground truth for diagnostic accuracy was established. The "ground truth" for the technical comparisons would be the specifications and performance characteristics of the predicate and reference devices, as determined by their respective manufacturers and validated through their own testing protocols.
8. The sample size for the training set:
Not applicable. This is a hardware device (X-ray Flat Panel Detector), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo has a blue square with the letters FDA in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 5, 2022
CareRay Digital Medical Technology Co., Ltd. % Xu Wei Manager A2-201/B3-501, Biobay,218 Xinghu Street, SuZhou Industrial Park, Suzhou, Jiangsu 215123 CHINA
Re: K221549
Trade/Device Name: X-ray Flat Panel Detectors (CareView 1800 RF) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, JAA
Dear Xu Wei:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 01, 2022. Specifically, FDA is updating this SE Letter as an administrative correction due to an omission of the secondary product code JAA.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Laurel Burk, OHT8: Office of In Vitro Diagnostics and Radiological Health, telephone (301)796-5933, Laurel.Burk(@fda.hhs.gov
Sincerely,
Laurel M.
Burk -S
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
August 1, 2022
CareRay Digital Medical Technology Co., Ltd. % Xu Wei Manager A2-201/B3-501, Biobay,218 Xinghu Street, SuZhou Industrial Park, Suzhou, Jiangsu 215123 CHINA
Re: K221549
Trade/Device Name: X-ray Flat Panel Detectors (CareView 1800 RF) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: May 27, 2022 Received: June 7, 2022
Dear Xu 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. 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
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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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel M. Burk -S
2022.08.01
09:56:48 -04'00'
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221549
Device Name
X-ray Flat Panel Detectors (CareView 1800RF)
Indications for Use (Describe)
The CareView 1800RF 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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510(k) Summary
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510(k) Summary
K221549
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
Mar. 18, 2022
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, SuzhouIndustrial 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 1800RF |
| Classification Name: | Stationary X-ray system |
| Regulation Number: | 21 CFR 892.1680 |
| Regulatory Class: | Class II |
| Product Code: | MQB,JAA |
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified primary predicates within this submission are as follows: Manufacturer: CareRay Digital Medical Technology Co., Ltd. Trade Name: X-ray Flat Panel Detectors Model Name: CareView 1800Le
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| Classification Name: | Stationary X-ray system |
|---|---|
| Regulation Number: | 21 CFR 892.1680 |
| Regulatory Class: | Class II |
| Product Code: | MQB |
| FDA 510(k) #: | K193173 |
| Reference Device: | |
| Manufacturer: | Rayence Co., Ltd. |
| Trade Name: | Digital Flat Panel X-ray Detector |
| Model Name: | 1717FCC |
| Classification Name: | Stationary X-ray system |
| Regulation Number: | 21 CFR 892.1680 |
| Regulatory Class: | Class II |
| Product Code: | MQB,JAA |
| FDA 510(k) #: | K210985 |
5. Description of the Device [21 CFR 807.92(a)(4)]
The CareView 1800RF detector is a class of radiography X-ray flat panel detector that has an imaging area of 434 mm × 434 mm. 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.
The CareView 1800RF detector can be used for dynamic imaging (fluoroscopy).
6. Intended Use [21 CFR 807.92(a)(5)]
The CareView 1800RF 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.
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7. Technological Characteristics [21 CFR 807.92(a)(6)]
Comparison with the predicate device
| Item | Proposed Device:X-ray Flat Panel Detectors | Predicate Device:X-ray Flat Panel Detectors |
|---|---|---|
| 510(K) Number | K221549 | K193173 |
| Model | CareView 1800RF | CareView 1800Le |
| Intended Use | The CareView 1800RF detector isindicated for digital imaging solutiondesigned for providing generalradiographic diagnosis of humananatomy. It is intended to replaceradiographic film/screen systems in allgeneral-purpose diagnostic procedures.This product is not intended formammography applications. | The CareView 1800Le detectoris indicated for digital imagingsolution designed for providinggeneral radiographic diagnosisof human anatomy. It is intendedto replace radiographicfilm/screen systems in allgeneral-purpose diagnosticprocedures. This product is notintended for mammographyapplications. |
| Classification Name | Stationary X-ray system | Stationary X-ray system |
| Regulation Number | 892.1680 | 892.1680 |
| Panel | Radiology | Radiology |
| Class | II | II |
| X-ray Absorber | Csl Scintillator | Csl Scintillator |
| Installation Type | Wired, Cassette | Wired, Cassette |
| ReadoutMechanism | Thin Film Transistor | Thin Film Transistor |
| Image Matrix Size | 2816 × 2816 pixels | 3072 × 3072 pixels |
| Pixel Pitch | 154μm | 140μm |
| Effective ImagingArea | 434 mm × 434 mm | 430 mm × 430 mm |
| Grayscale | 16 bit, 65536 grayscale | 16 bit, 65536 grayscale |
| Spatial Resolution | 3.3 line pair/mm | 3.57 line pair/mm |
| MTF | ≥60%..........(@ 1lp/mm)≥30%..........(@ 2lp/mm)≥17%..........(@ 3lp/mm) | ≥63%..........(@ 1lp/mm)≥35%..........(@ 2lp/mm)≥17%..........(@ 3lp/mm) |
| DQE | (@RQA5, 2µGy)≥55%..........(@ 1lp/mm)≥20%..........(@ 3lp/mm) | (@RQA5, 30µGy)≥62%..........(@ 1lp/mm)≥45%..........(@ 1lp/mm)≥17%..........(@ 3lp/mm) |
| RatedPowerSupply | DC 24 V, Max.1.25 A | DC +24 V, Max.1 A |
| Network interface | Gigabit Ethernet | Gigabit Ethernet |
| Imaging Plate | Carbon Fiber Plate | Carbon Fiber Plate |
| Cooling | Air cooling | Air cooling |
| Dimensions | 460mm x 460mm x 28mm | 460 mm x 460 mm x 15 mm |
| Operation | Temperature: +10 ~ +40°CHumidity: 30 ~ 75% (Non-Condensing)Atmospheric pressure: 700 ~ 1060 hPa | Temperature: +5 ~ +35°CHumidity: 30 ~ 75% (Non-Condensing)Atmospheric pressure: 700 ~ 1060 hPa |
| Storage andtransportation | Temperature: -20 ~ +55°CHumidity: 10 ~ 90% (Non-Condensing)Atmospheric pressure: 700 ~ 1060 hPa | Temperature: -20 ~ +55°CHumidity: 10 ~ 90% (Non-Condensing)Atmospheric pressure: 700 ~ 1060 hPa |
| UtilizedguidancedocumentsFDA | 1. Guidance for the Submission of510(k)s for Solid State X-rayImaging Devices2. The 510(k) Program: EvaluatingSubstantial Equivalence inPremarket Notifications[510(k)]3. Pediatric Information for X-rayImaging Device PremarketNotifications4. Radio Frequency WirelessTechnology in Medical devices5. Guidance for the Content ofPremarket Submissions for SoftwareContained in Medical Devices6. Content of Premarket Submissionsfor Management of Cybersecurity inMedical Devices | 1. Guidance for the Submissionof 510(k)s for Solid StateX-ray Imaging Devices2. The 510(k) Program:Evaluating SubstantialEquivalence in PremarketNotifications [510(k)]3. Pediatric Information forX-ray Imaging DevicePremarket Notifications4. Guidance for the Content ofPremarket Submissions forSoftware Contained inMedical Devices5. Content of PremarketSubmissions forManagement ofCybersecurity in MedicalDevices |
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Comparison with Reference Device
| Item | Proposed Device:X-ray Flat Panel Detectors | Reference Device:Digital Flat Panel X-ray Detector |
|---|---|---|
| 510(K) Number | K221549 | K210985 |
| Model | CareView 1800RF | 1717FCC |
| K221549 | K210985 | |
| Intended Use | The CareView 1800RF detectoris indicated for digital imagingsolution designed for providinggeneral radiographic diagnosis ofhuman anatomy. It is intended toreplace radiographic film/screensystems in all general-purposediagnostic procedures. Thisproduct is not intended formammography applications. | 1717FCC is indicated for digitalimaging solution designed forgeneral radiographic system forhuman anatomy.It is intended toreplace film or screen basedradiographic systems in allgeneral purpose diagnosticprocedures. Not to be used formammography. |
| Classification | Stationary X-ray system | Stationary X-ray system |
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| Name | ||
|---|---|---|
| Product Code | MQB,JAA | MQB,JAA |
| Regulation Number | 21 CFR 892.1680 | 21 CFR 892.1680 |
| Panel | Radiology | Radiology |
| Class | II | II |
| X-ray Absorber | CsI Scintillator | CsI Scintillator |
| Detector Type | TFT | Amorphous Silicon (a-Si) TFT +PIN type photodiodeIGZO TFT + PIN type photodiode |
| Image Matrix Size | 2816 x 2816 pixels | 3000 x 3000 pixels |
| Pixel Pitch | 154µm | 140µm |
| Effective ImagingArea | 434 mm x 434 mm | 17 x 17 inches |
| Grayscale | 16 bit | 14/16 bit |
| Spatial Resolution | 3.3 lp/mm | 3.5 lp/mm |
| Pixel matrix | 154 μm: 2816×2816 (1x1 binning)308 μ m: 1408×1408 (2x2 binning)462 μ m: 896×896 (3x3 binning) | 140 type: 3000 x 3000 (Full resolution)280 type: 1500 x 1500 (2x2 binning)420 type: 1000 x 1000 (3x3 binning)560 type: 750 x 750 (4x4 binning) |
| Frame rate | 4fps@2816×281615fps@1408×140825fps@896×896 | GigE6 @ (1x1)25 @ (2x2)45 @ (3x3)60 @ (4x4)Camera link9 @ (1x1)30 @ (2x2)45 @ (3x3)60 @ (4x4)5GigE15 @ (1x1)30 @ (2x2)45 @ (3x3)60 @ (4x4) |
8. System requirements to operate with other radiographic system components
The submitted medical device is the CareView 1800RF 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)
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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: 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
-
- 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 1800RF 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. -
A Nonclinical and clinical considerations
The proposed device (CareView 1800RF) and predicate device (CareView 1800Le) share most of primary product specifications including intended use, technology, material, and imaging principle, power supply method etc.
The Intended Use, pixel matrix and frame rate for the proposed device CareView 1800RF is similar to the specification of the reference device 1717FC (K210985) .
- A Clinical images are not necessary for the current submission. Successful results of bench testing should be sufficient to show substantial equivalence for the subject 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 1800RF X-ray flat
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panel detectors are substantially equivalent to predicate device CareView 1800Le X-ray flat panel detectors (K193173) and reference device(K210985). 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 1800RF X-ray flat panel detectors are substantially equivalent with the predicate device with regard to safety and effectiveness.
§ 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.