(150 days)
VIVIX-S 1012N (FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW) is indicated for digital imaging solution designed as a general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purposes of diagnostic procedures. It is not to be used for mammography.
Models FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW intercept X-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create an electrical signals. After the electrical signals are generated, these are converted to a digital value, and an image will be displayed on the monitor.
These devices should be integrated with an operating PC and an X-Ray generator to digitalize Xray images and transfer the digitalized images for radiography diagnostic.
Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and image information sharing on the network.
The provided text does not contain detailed acceptance criteria or a comprehensive study design that allows for the extraction of all requested information. The document is a 510(k) summary for a digital X-ray detector, focusing on demonstrating substantial equivalence to predicate devices rather than a detailed performance study against specific acceptance metrics derived independently.
However, based on the available information, here's a breakdown of what can be inferred and what is missing:
Missing Information:
- Detailed, explicit acceptance criteria values (e.g., specific thresholds for DQE, MTF that had to be met by the new device, beyond "similar"). The document states "...meet the acceptance criteria...", but these criteria themselves are not listed with numerical targets.
- The exact sample size for the clinical test set (only "a single-blinded concurrence study" is mentioned).
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for the test set.
- Details of any Multi-Reader Multi-Case (MRMC) comparative effectiveness study, including effect size.
- Standalone algorithm performance (this device is a digital X-ray detector, not an AI algorithm, so this concept doesn't directly apply).
- Sample size for the training set (as this is a medical device, not an AI model, there isn't a "training set" in the typical sense of machine learning).
- How ground truth for the training set was established (again, not applicable to this type of device).
Inferred Information based on the document:
The study primarily focuses on demonstrating substantial equivalence to predicate devices (K122865 and K122866) by comparing technological characteristics and performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" with numerical thresholds that the new device must meet. Instead, it compares the performance of the subject device (VIVIX-S 1012N models) to the predicate devices. The "acceptance" is implicitly that the performance of the new device is similar or better than the predicate devices, particularly in areas like DQE and MTF.
Here's a table showing the performance comparison provided, which serves as the "reported device performance" against the implicitly accepted "similar to predicate" standard:
| Parameter (Measurement Point) | Acceptance Criteria (Implied) | Reported Device Performance (VIVIX-S 1012N) | Reference Predicate (K122865) Performance | Primary Predicate (K122866) Performance |
|---|---|---|---|---|
| DQE (Csl scintillator) | Similar or better than predicate | |||
| 0.5 lp/mm | Implicit: ~59% | 59% | (Not explicitly listed for Reference) | 59% |
| 1 lp/mm | Implicit: ~53% | 53% | (Not explicitly listed for Reference) | 53% |
| 2 lp/mm | Implicit: ~45% | 45% | (Not explicitly listed for Reference) | 45% |
| 3 lp/mm | Implicit: ~27% | 34% | (Not explicitly listed for Reference) | 27% |
| DQE (Gadox scintillator) | Similar or better than predicate | |||
| 0.5 lp/mm | Implicit: ~37% | 37% | (Not explicitly listed for Reference) | 37% |
| 1 lp/mm | Implicit: ~31% | 31% | (Not explicitly listed for Reference) | 31% |
| 2 lp/mm | Implicit: ~20% | 20% | (Not explicitly listed for Reference) | 20% |
| 3 lp/mm | Implicit: ~9% | 11% | (Not explicitly listed for Reference) | 9% |
| MTF (Csl scintillator) | Similar or better than predicate | |||
| 0.5 lp/mm | Implicit: ~81% | 87% | (Not explicitly listed for Reference) | 81% |
| 1 lp/mm | Implicit: ~58% | 71% | (Not explicitly listed for Reference) | 58% |
| 2 lp/mm | Implicit: ~28% | 43% | (Not explicitly listed for Reference) | 28% |
| 3 lp/mm | Implicit: ~15% | 22% | (Not explicitly listed for Reference) | 15% |
| MTF (Gadox scintillator) | Similar or better than predicate | |||
| 0.5 lp/mm | Implicit: ~80% | 80% | (Not explicitly listed for Reference) | 80% |
| 1 lp/mm | Implicit: ~56% | 56% | (Not explicitly listed for Reference) | 56% |
| 2 lp/mm | Implicit: ~24% | 26% | (Not explicitly listed for Reference) | 24% |
| 3 lp/mm | Implicit: ~10% | 11% | (Not explicitly listed for Reference) | 10% |
| Resolution | Similar or better than predicate | 4.0 lp/mm | - | 3.5 lp/mm |
Note: For DQE and MTF values, the table for the "Reference Predicate Devices" (K122865) shows "-" for these performance metrics, while the "Primary Predicate Devices" (K122866) has values. The "Comparison test" in section 9 explicitly states comparison was done with K122866.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the clinical test set, only mentioned as "a single-blinded concurrence study."
- Data Provenance: Not specified (e.g., country of origin). The study is described as a "clinical test" which "complied with the requirements specified in the CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices," suggesting a prospective or collected dataset for the purpose of the submission. It's not explicitly stated as retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The study is described as a "single-blinded concurrence study." This implies that evaluators were blinded to which images came from the new device versus the predicate, and their interpretations were compared for "concurrence," but the method of resolving discrepancies or establishing definitive ground truth from multiple readers is not detailed.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Was it done?: The document describes a "single-blinded concurrence study" comparing images from the new device to the predicate device to confirm "equivalent diagnostic capability." This is a form of comparative study involving human readers (though the number of readers is not disclosed), but it is focused on demonstrating equivalence (non-inferiority) rather than improvement with AI assistance.
- Effect Size of Human Reader Improvement: Not applicable, as this is a comparison between two different X-ray detectors, not an AI-assisted workflow vs. unassisted human reading.
6. Standalone (Algorithm Only) Performance
- Was it done?: Not applicable. The device (VIVIX-S 1012N) is a digital X-ray detector, a hardware component that captures images. It is not an AI algorithm. The performance metrics (DQE, MTF, Resolution) are intrinsic to the image capture capabilities of the detector.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "concurrence study," the ground truth was based on the "equivalent diagnostic capability" of the images as assessed by human readers ("experts"). This would typically mean that clinical interpretations of images from the new device were compared to interpretations of images from the predicate device to ensure they did not differ significantly in diagnostic content. It is a form of expert consensus on image diagnostic quality, rather than a definitive "true positive/negative" based on pathology or outcomes data.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a digital X-ray detector, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Established: Not applicable.
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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 a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2016
Vieworks Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 E. Chapman Avenue, Suite 110 FULLERTON CA 92831
Re: K152855
Trade/Device Name: VIVIX-S 1012N Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: January 28, 2016 Received: February 2, 2016
Dear Ms. Chung:
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'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}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K152855
Device Name
VIVIX-S 1012N
Indications for Use (Describe)
VIVIX-S 1012N (FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW) is indicated for digital imaging solution designed as a general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purposes of diagnostic procedures. It is not to be used for mammography.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
[As required by 21 CFR 807.92] (K152855)
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR807.92
1. Date Prepared [21 CFR 807.92(a) (1)]
01/28/2016
2. Submitter's Information [21 CFR 807.92(a) (1)]
| Name of Sponsor: | Vieworks Co., Ltd. |
|---|---|
| Address: | (Gwanyang-dong) |
| 41-3,Burim-ro 170beon-gil,Dongan-gu, | |
| Anyang-si, Gyeonggi-do, 431-060 Republic of Korea | |
| Contact Name: | Im, Yoonjae / RAQA team Manager |
| Registration Number: | 3006013411 |
| Name of Manufacturer: | Same as Sponsor |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]
| Trade Name: | VIVIX-S 1012N |
|---|---|
| Model Name: | FXRD-1012NAFXRD-1012NBFXRD-1012NAWFXRD-1012NBW |
| Common Name: | Digital Flat Panel X-ray Detector |
| Classification Name: | Stationary X-ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR 892.1680 |
| Product Code: | MQB |
| Device Class: | 2 |
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
Primary Predicate Device:
.
510(k) Number: K122866 Product Code: MQB Applicant: Vieworks Co., Ltd. Trade Name: ViVIX-S with VXvue
{4}------------------------------------------------
| Model Name: | FXRD-1417SA |
|---|---|
| FXRD-1417SB | |
| FXRD-1717SA | |
| FXRD-1717SB | |
| Decision Date: | 01/11/2013 |
Reference Predicate Device
| • 510(k) Number: | K122865 |
|---|---|
| Product Code: | MQB |
| Applicant: | Vieworks Co., Ltd. |
| Trade Name: | ViVIX-S Wireless |
| Model Name: | FXRD-1417WA |
| FXRD-1417WB | |
| Decision Date: | 02/01/2013 |
5. Description of the Device [21 CFR 807.92(a) (4)]
General Description o
Models FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW intercept X-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create an electrical signals. After the electrical signals are generated, these are converted to a digital value, and an image will be displayed on the monitor.
These devices should be integrated with an operating PC and an X-Ray generator to digitalize Xray images and transfer the digitalized images for radiography diagnostic.
Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and image information sharing on the network.
Differences between models O
Models FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW are digital X-ray flat panel detectors, and each model has a 10 x 12 inch imaging area.
FXRD-1012NA and FXRD-1012NB communicate by using a wired communication feature (Gigabit Ethernet communication method by connecting to a tether cable), while FXRD-1012NAW and FXRD-1012NBW communicate by using a wireless communication feature (IEEE 602.lla/b/g/n).
The scintillator used in FXRD-1012NA and FXRD-1012NAW is Csl. Gadox was used for FXRD-1012NB and FXRD-1012NBW.
The FXRD-1012N series is designed to be used with any certified X-ray generators that features DR Trigger mode and is marketed legally. When the DR Trigger mode is not desired, then the connection with the generator can be maintained with AED mode. FXRD-1012N is not designed to function as an X-ray control. The AED mode does not require integration procedure since there is no connection requirement between the X-ray System and the detector. The subject device can receive any types of x-ray signals without SW.
For the DR Trigger mode, the generator interface cable connects the SCU and the X-ray generator. The head of the cable is connected with one of the port (EXT-INF) of the SCU, and the other end of the cable (which is stripped) is connected to the generator's socket.
{5}------------------------------------------------
6. Intended Use [21 CFR 807.92(a)(5)]
VIVIX-S 1012N (FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW)is indicated for digital imaging solution designed as a general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purposes of diagnostic procedures. It is not to be used for mammography.
7. Technological Characteristics [21 CFR 807.92(a) (6)]
Comparisons with the predicate, devices show the technological characteristics of the proposed FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW devices to be substantially equivalent to the predicate devices. The proposed devices are functionally identical to the predicate devices.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
When compared to the predicate devices (K122865 andK122866),the FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW presented in this submission have the same:
- · Intended Use
- Technological characteristics
- Operating principle
- · Design features
- Communication Method
- ScintillatorMaterials
- Resolution
There are similar performance characteristics as follow.
- Performance (MTF)
- Performance (DQE)
There are no significant difference between the FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.
| Parameter | Reference PredicateDevices | Primary PredicateDevices | Subject Device |
|---|---|---|---|
| 510(k) Number | K122865 | K122866 | K152855 |
| Manufacturer | Vieworks Co., Ltd. | ||
| Model Name | FXRD-1417WA,FXRD-1417WB | FXRD-1417SA,FXRD-1417SB,FXRD-1717SA, | FXRD-1012NA,FXRD-1012NB,FXRD-1012NAW, |
{6}------------------------------------------------
| Common Name | FXRD-1717SB | FXRD-1012NBW | ||||
|---|---|---|---|---|---|---|
| Classification Name | Solid State X-Ray Imager (Flat Panel/Digital Imager) | |||||
| Classification Panel | Radiology | |||||
| Classification Regulation | 21 CFR 892.1680 | |||||
| Product Code | MQB | |||||
| Device Class | 2 | |||||
| Intended Use | The VIVIX-S Wireless isindicated for digitalimaging solutiondesigned as a generalradiographic systemfor human anatomy. Itis intended to replacefilm or screen basedradiographic systemsin all general purposesof diagnosticprocedures. It is not tobe used formammography. | VIVIX-S with VXvue isindicated for digitalimaging solutiondesigned for generalradiographic systemfor human anatomy. Itis intended to replacefilm or screen basedradiographic systemsin all general purposediagnostic procedures.Not to be used formammography. | FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW areindicated for digitalimaging solutiondesigned as a generalradiographic systemfor human anatomy. Itis intended to replacefilm or screen basedradiographic systemsin all general purposesof diagnosticprocedures. It is not tobe used formammography. | |||
| Design | Panel Shape | Square Panel | Square Panel | Square Panel | ||
| Field of View | 14 x 17inch | 14 x 17inch17 x 17inch | 10 x 12inch | |||
| Dimensions(H x W x D) | 444 x 460 x15mm | 444 x 460 x15 mm 470x 470x 35mm | 287.0 x 350.0 x15.0mm | |||
| Pixel Pitch | 0.14mm | 0.14mm | 0.124mm | |||
| Materials Scintillator | Csl: TI,Gd2O2S:Tb | Csl: TI,Gd2O2S:Tb | Csl: TI,Gd2O2S:Tb | |||
| Performance | DQE | - | Csl | Csl | ||
| 0.5 lp/mm | - | 59 | 59 | |||
| 1 lp/mm | - | 53 | 53 | |||
| 2 lp/mm | - | 45 | 45 | |||
| 3 lp/mm | - | 27 | 34 | |||
| DQE | - | Gadox | Gadox | |||
| 0.5 lp/mm | - | 37 | 37 | |||
| 1 lp/mm | - | 31 | 31 | |||
| 2 lp/mm | - | 20 | 20 | |||
| 3 lp/mm | - | 9 | 11 | |||
| MTF | - | Csl | Csl | |||
| 0.5 lp/mm | - | 81 | 87 | |||
| 1 lp/mm | - | 58 | 71 | |||
| 2 lp/mm | - | 28 | 43 | |||
| 3 lp/mm | - | 15 | 22 |
{7}------------------------------------------------
| MTF | - | Gadox | Gadox |
|---|---|---|---|
| 0.5 lp/mm | - | 80 | 80 |
| 1 lp/mm | - | 56 | 56 |
| 2 lp/mm | - | 24 | 26 |
| 3 lp/mm | - | 10 | 11 |
| Resolution | - | 3.5 lp/mm | 4.0 lp/mm |
| Communication Method | Wireless | Wired | Wired,Wireless |
9. Summary of Non-Clinical Data
A comparison test was conducted between the subject devices (FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW) and the predicate device (K122866) on the items such as DQE, MTF and spatial resolution.Test results support that the subject device is substantially equivalent to the predicate device.
These detectors comply with the following international and FDA-recognized consensus standards:
| [IEC 60601-1 2005, Edition 3.0] | Medical Electrical Equipment -- Part 1: GeneralRequirements For Basic Safety And Essential Performance |
|---|---|
| [IEC 60601-1-2, Edition 3] | Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility -Requirements And Tests |
| [IEC 62220-1, Edition 1.0] | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detectivequantum efficiency |
| [NEMA PS 3.1 - 3.20 2011] | Digital Imaging and Communications in Medicine (DICOM)Set |
| [ETSI] [EN 300 328 1.8.1] | Electromagnetic compatibility and Radio spectrum Matters(ERM); Wideband transmission systems; Data transmissionequipment operating in the 2,4 GHz ISM band and usingwide band modulation techniques; Harmonized ENcovering the essential requirements of article 3.2 of theR&TTE Directive |
| [ETSI EN 301 893 1.7.1] | Broadband Radio Access Networks (BRAN); 5 GHz highperformance RLAN; Harmonized EN covering the essentialrequirements of article 3.2 of the R&TTE Directive |
| [IEC 62133, Edition 2.0] | IEC 62133 Edition 2.0 2012-12 Secondary Cells AndBatteries Containing Alkaline Or Other Non-AcidElectrolytes•Safety Requirements For Portable SealedSecondary Cells, And For Batteries Made From Them, ForUse In Portable Applications [Including: Corrigendum 1(2013) |
{8}------------------------------------------------
10. Summary of Clinical Data
A single-blinded concurrence study according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices was conducted, and the study confirmed that the new x-ray detectors FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW provide images of equivalent diagnostic capability to the predicate device(K122865), the ViVIX-S wireless (FXRD-1417WA and FXRD-1417WB), and its results demonstrate substantial equivalence.
11. Conclusion [21 CFR 807.92(b) (3)]
The FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW Digital X-ray detectors are substantially equivalent to the currently marketed and predicate devices (K122865, and K122866) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, Substantial equivalence was demonstrated through the non-clinical performance, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC60601-1-2, IEC62220-1 and NEMA PS 3.1 - 3.20, IEC 62133 and the clinical test, which complied with the requirements specified in the CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.
The results of these tests demonstrate that FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW Digital X-ray detectors meet the acceptance criteria and are adequate for this intended use. The comparison of technological characteristics, non-clinical performance data, safety testing, and clinical image concurrence data demonstrates that the device is as safe, as effective, and performs as well the predicate devices.
§ 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.