(384 days)
The X Twin is intended to be used as a digital multifunctional x-ray system, suitable for all radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography.
X Twin shall only be operated by qualified, trained professionals. The patient can be in sitting, lying or standing position.
The device is a permanently installed device and is intended to be operated in medical rooms with appropriate radiation protection only. It is not intended to be used with flammable anesthetic agents or in potentially explosive atmospheres.
The X Twin is a digital multifunctional x-ray system, in which an X Twin stand holds the xray image receptor, the collimator and the x-ray tube including the x-ray tube housing assembly. The generator, x-ray tube, beam limiting device, image receptor, including the workstation for image processing plus imaging software and the optional mobile x-ray table are known components. The geometry of the X Twin contains two guide frames, two support arms, an x-ray tube column and an image receptor column. The movements of the columns and the arms as well as the SID adjustment are motorized. The x-ray tube support arm as well as the image receptor support arm is provided with an integrated control unit, located at the front of the support arms. These units allow an adjustment of angle, height and distance of the image receptor and x-ray in relation to the patient. Simultaneously an integrated electronic control system provides automatic focusing of the image receptor and x-ray tube. Additionally an integrated touch display for indication of current values and additional control options is implemented in the tube support arm. The device receives its power from the x-ray generator.
The provided document is a 510(k) premarket notification for a medical device called the "X Twin System," which is a digital multifunctional x-ray system. The document focuses on demonstrating substantial equivalence to a predicate device and includes summaries of non-clinical and clinical performance testing. However, it does not explicitly define acceptance criteria in terms of specific performance metrics or provide a detailed study that proves the device meets such criteria for diagnostic accuracy.
The document states that the X Twin system itself did not undergo clinical testing but refers to clinical performance testing performed for the integrated Image Detector DFP4343C7 by its manufacturer, NIPK Electron (with 510(k) release number K122589). Without the full 510(k) submission for the DFP4343C7 detector, it is not possible to provide all details requested regarding acceptance criteria and its supporting study.
Based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for detecting specific conditions) for the X Twin System. Instead, the acceptance criteria are implicitly tied to demonstrating safety, efficacy, and substantial equivalence to the predicate device (Essenta DR, K070528) and the previously cleared Image Detector DFP4343C7.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety and Efficacy (General) | The X Twin system is deemed substantially equivalent to the predicate device Essenta DR (K070528). |
| Compliance with Electrical Safety Standards (IEC 60601-1) | The device complies with IEC 60601-1. |
| Compliance with X-ray Specific Standards (IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54) | The device underwent testing for half-value layer, focal spot to image receptor distance, and leakage radiation as per relevant test clauses. All test results were satisfactory. |
| Biocompatibility (ISO 10993) | No evidence was found that the surfaces of the X Twin system cause skin irritations or similar negative effects on the patient. The observed surface coatings have a 10-year history of safe use on similar medical devices. |
| Software Level of Concern (per FDA Guidance for Software in Medical Devices) | The X Twin Control Software and the Imaging Software DXRS were classified as "Moderate" Level of Concern. The documentation and testing were performed in accordance with the guidance. The DXRS software was part of the 510(k) Premarket Notification No. K122589 (for the Image Detector DFP4343C7). |
| Image Detector DFP4343C7 Performance (Non-Clinical) (per Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices) | Non-clinical performance testing was performed by NIPK Electron (as 510(k) Applicant for K122589). All test results were satisfactory. (Specific metrics for image quality, resolution, DQE, MTF, etc., are not provided in this document but would be in K122589). |
| Image Detector DFP4343C7 Performance (Clinical) (per Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices) | Clinical Performance Testing was performed by NIPK Electron (as 510(k) Applicant for K122589). All test results were satisfactory. (Specific outcomes, diagnostic equivalence, or performance metrics are not detailed in this document but would be in K122589). The X Twin system itself did not perform clinical testing, relying on the clearance of its integrated detector. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- For the X Twin System (as a whole): The document states, "Roesys GmbH did not perform any clinical testing for the X Twin." Therefore, there is no test set sample size or data provenance provided for the X Twin system directly.
- For the Image Detector DFP4343C7: Clinical performance testing was performed by NIPK Electron. This document does not provide the sample size, data provenance (country, retrospective/prospective), or study design details for that specific testing. This information would be found in the K122589 submission.
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):
- This information is not provided in the document for the X Twin System, as no direct clinical testing was performed by Roesys GmbH.
- For the Image Detector DFP4343C7's clinical study (K122589), these details would be available in its specific submission, but are not present here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the X Twin System's submission as presented here, as no direct clinical test set was used by Roesys GmbH for diagnostic performance.
- The adjudication method for the DFP4343C7's clinical study is not detailed in this document.
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:
- No MRMC comparative effectiveness study is mentioned or implied for the X Twin System. The device is a conventional X-ray system, not an AI-based diagnostic tool.
- The document does not indicate the presence of AI assistance within the X Twin control software or the DXRS imaging software that would involve human readers improving with AI. The software functions described are for control of the X-ray system and image processing/viewing, not AI-powered diagnostic interpretations.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The X Twin System is an X-ray imaging device; its software controls the device and processes images for human interpretation, it is not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Since no clinical diagnostic performance study for the X Twin system is presented by Roesys GmbH, the type of ground truth is not specified for this submission.
- For the clinical performance testing for the Image Detector DFP4343C7 (K122589), this information would be within that specific submission.
8. The sample size for the training set:
- Not applicable, as this device does not involve machine learning or AI models with training sets for diagnostic purposes. The software controls mechanical movements and image display/processing.
9. How the ground truth for the training set was established:
- Not applicable, as this device does not involve machine learning or AI models with training sets.
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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 features the department's name encircling a stylized emblem. The emblem depicts a stylized caduceus, a symbol often associated with healthcare, with a triple helix design representing the interconnectedness of health and human services. The text is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 3, 2014
Roesys GmbH % Mr. Jochen Dyszbalis Quality Manager Dr .- Max-Ilgner-Str. 2 Espelkamp, Nordrhein-Westfalen 32339 GERMANY
Re: K133496
Trade/Device Name: X Twin System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 22, 2014 Received: October 24, 2014
Dear Mr. Dyszbalis:
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.
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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 A Ochs
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K133496
Device Name X Twin System
Indications for Use (Describe)
The X Twin is intended to be used as a digital multifunctional x-ray system, suitable for all radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography.
X Twin shall only be operated by qualified, trained professionals. The patient can be in sitting, lying or standing position.
The device is a permanently installed device and is intended to be operated in medical rooms with appropriate radiation protection only. It is not intended to be used with flammable anesthetic agents or in potentially explosive atmospheres.
Type of Use (Select one or both, as applicable)
X 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)
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510(k) Summary
Name and Address of manufacturer:
Roesys GmbH Dr.-Max-Ilgner-Straße 2 32339 Espelkamp Germany
Owner/Operator Number: 10045270
Name, title and phone number of official correspondent: Jochen Dyszbalis Quality Manager +49 5772 91555 00
| Date of preparation: | November 11, 2013 |
|---|---|
| ---------------------- | ------------------- |
Device Identification:
| Device Trade Name: | X Twin |
|---|---|
| Common Name: | General purpose diagnostic X-ray unit |
Classification of the device:
| Device Classification Name: | System, X-ray, Stationary |
|---|---|
| Product Code: | KPR |
| Device Classification No.: | Part 892.1680 |
| Panel: | Radiology |
| Regulatory Status: | Class II |
Predicate device:
Device Trade Name: Applicant: 510(k) No.:
Essenta DR Philips Medical Systems DMC GmbH K070528
Device Description:
X Twin
The X Twin is a digital multifunctional x-ray system, in which an X Twin stand holds the xray image receptor, the collimator and the x-ray tube including the x-ray tube housing
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assembly. The generator, x-ray tube, beam limiting device, image receptor, including the workstation for image processing plus imaging software and the optional mobile x-ray table are known components. The geometry of the X Twin contains two guide frames, two support arms, an x-ray tube column and an image receptor column. The movements of the columns and the arms as well as the SID adjustment are motorized. The x-ray tube support arm as well as the image receptor support arm is provided with an integrated control unit, located at the front of the support arms. These units allow an adjustment of angle, height and distance of the image receptor and x-ray in relation to the patient. Simultaneously an integrated electronic control system provides automatic focusing of the image receptor and x-ray tube. Additionally an integrated touch display for indication of current values and additional control options is implemented in the tube support arm. The device receives its power from the x-ray generator.
Imaqinq Device
An essential part of the X-ray system X Twin is the digital Flat Panel Image Detector. In the X Twin System is mounted the Digital X-ray Detector DFP4343C7. The Digital X-ray Detector DFP4343C7 is a medical image processing unit. Especially, advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, real-time sharing of image information on network. DFP4343C7 is a highresolution digital imaging detector, designed for general radiography. The X-ray Conversion Layer consists of Cesium lodide (Csl) with Amorphous Silicon (a-Si) Photodiode. The active area has a size of 430(H)x439(V)mm (16.9×17.3 inch), the Pixel Matrix has a size of 3008(H)x3072(V) with a Pixel Pitch of 143 µm.
The Cycle Time from Shot to Shot is 6sec.
The Digital X-ray Detector DFP4343C7 is released by the FDA in a 510 (k) process. The Release Number is K122589.
Software
The software used in the X Twin consists of two systems:
X Twin Control Software ●
The X Twin Control Software controls only the motorized adjustment of angle, height and distance of the image receptor and x-ray in relation to the patient. These movements are only possible if corresponding switches are manually operated. When the switch is released, the movement is stopped immediately. Simultaneously an integrated electronic control system provides automatic focusing of the image receptor and x-ray tube. This function is also only possible during manually operated switches.
The angle and the SID is displayed on the control unit on the support arm of the X Twin. The control software controls also the emergency stop buttons ant the collision protection of the X Twin. The control software neither provides automatically movement actions nor does it take influence on the diagnosis.
Failures or latent design flaws are unlikely to cause any injury to the patient or operator. In accordance to the Guidance for Software used in Medical Devices Roesys has determined the Level of Concern of the X Twin Control software as Moderate.
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Imaging Software DXRS .
DXRS software is intended for acquisition, processing, viewing, printing, saving and transmittance of X-ray images to PACS server. DXRS software can retrieve patient data from other information systems (HIS/RIS).
DXRS software includes a main application (below referred to as SW application), its modules and utilities. SW application provides declared functionality. Modules and utilities provide additional functionality.
Brief description of the operation scenario
Operation scenario includes a sequence of actions described below. Manual input of patient data or its automatic retrieval using Worklist function. Acquisition of X-ray image by the detector manufacturer's service software, supplied with the detector. SW application displays recommended values of exposure parameters which operator can use to acquire an X-ray image of a specific body part. Recommended values are only displayed and do not define or influence exposure process in practice in any way.
Image processing is carried out manually to prepare images for diagnostics. Image processing includes zoom, navigation, flip and rotation, inversion, usage of collimators (program shutters) and adjustment of Window Width/Level. SW application also provides lateralization and a rollback function which removes results of actions applied to the image and brings image back to the initial state. As a result of post-processing operations, the image is ready to be displayed or to be used for diagnostic purposes.
Sending acquired X-ray images to a PACS server for storage
Printing images or creation of Patient Disks (if necessary)
In accordance to the Guidance for Software used in Medical Devices the Level of Concern for our device is Moderate. DXRS Software and the accompanying Digital X-Ray Detector DFP4343C7 are designed only for general radiographic systems. They are used neither in X-ray surgery nor mammography nor in life supporting systems. The DXRS software was part of the 510(k) Premarket Notification No. K122589.
Intended Use:
The X Twin is intended to be used as a digital multifunctional x-ray system, suitable for all radiographic examinations including specialist areas like trauma or pediatric work, excluding mammography.
X Twin shall only be operated by qualified, trained professionals. The patient can be in sitting, lying or standing position.
The device is a permanently installed device and is intended to be operated in medical rooms with appropriate radiation protection only. It is not intended to be used with flammable anesthetic agents or in potentially explosive atmospheres.
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Table 1: Substantial Equivalence Chart
| Substantial Equivalent Device | Predicate Device | ||
|---|---|---|---|
| X Twin | Essenta DR (K070528) | ||
| Intended Use | The X Twin is intended to be usedas a digital multifunctional x-raysystem, suitable for all radiographicexams, including specialist areaslike trauma or pediatric work,excluding mammography.X Twin shall only be operated byqualified, trained professionals. Thepatient can be in sitting, lying orstanding position.The device is a permanentlyinstalled device and is intended tobe operated in medical rooms withappropriate radiation protectiononly. It is not intended to be usedwith flammable anesthetic agentsor in potentially explosiveatmospheres. | The ESSENTA DR is a digitalmultifunctional X-ray system,suitable for all routineradiographic exams, includingspecialist areas like trauma orpediatric work, excludingmammography. It is designedfor radiographic examination ofthe standing or seated patientor the recumbent patient incombination with a mobile x-ray table (trolley). The systemis intended for direct digitalimaging using the built in flatpanel detector and in additionfor free exposures onradiographic cassettes. | Similar |
| Targetpopulation | Adult and pediatric subjects | Adult and pediatric subjects | Equivalent |
| Operator | Qualified trained professionals | Qualified/trained doctor ortechnicians | Equivalent |
| EnergySource | 400 V / 480 V ± 10%, 50/60 Hz | 400 V / 480 V ± 10%, 50/60 Hz | Equivalent |
| Powerconsumption | 24 - 44 kVA | 50 - 80 kVA | Advanced, thepowerconsumption isreduced, but theX-Rayparameters aresimilar |
| Maximumoutput | Depends on chosen generatormodel. | Depends on model ofgenerator chosen.Models are available from 50kW to 80 kW. | Equivalent |
| UserInterface | Software Driven Touch Panel LCD+ two individual control unitslocated at each support arm (one isa wired remote control) | Software Driven Touch PanelLCD,+ remote control unit | Similar |
| Columns | Two columns (tube & receptor).Guide frame mounted on floor | One main column.Floor or wall mounted support | Different, butdoes notconcern safetyor efficacy |
| Tube mount | Fixed to a tube column, arm canrotateAutomatic focusing by an integratedcontrol system | Fixed with respect to receptor,arm can rotate | Advanced |
| Receptormount | Fixed to a receptor column, armcan rotateAutomatic focusing by an integratedcontrol system | Fixed on same column as tubehead | Difference:Fixed to aseparatecolumn;Does notconcern safetyor efficacy |
| Method ofcontrol | Software Driven Touch Panel LCD,+ two individual control unitslocated at each support arm(one is a wired remote control) | Software Driven Touch PanelLCD,+ remote control unit+ Detector control unit | Similar |
| Electricalsafety | IEC 60601-1 | IEC 60601-1 | Equivalent |
| Source-to-imagedistance(SID) | vertical: 40 -110 cm (16-44")horizontal: 100-200 cm (40-79")(also continuously adjustable anddual speed motorized) | 110-200 cm (43-79")continuously adjustable(dual speed motorizedmovement) | Advanced |
| Verticaltravel | 1,600 mm (63") | 1,330 mm (4' 4.4") | Equivalent |
| Longitudinaltravel | 100 cm (40")(each column) | None | Advanced |
| Rotationangle | ± 100°(each arm) | -30° to +135° | Different, butdoes notconcern safetyor efficacy |
| Total weight | 175 kg +410 kg = 585 kg(1x 1290 lb)(Guide frame with column + Verticalpillar) | 300 kg (661.5 lb) | Different, butdoes notconcern safetyor efficacy |
| ImageDetector | Electronic flat detector with HighStability ScinitillatorActive detector area: 35 cm x 43cm (14" x 17") with rotatabledetector carrierlmage matrix size: 1920 pixel x2367 pixelPixel size: 182 µm, with a pixeldepth of 14 bits | Flat Panel Detector withCesium lodide (Csl) for X-rayscintillatorActive detector area: 43 cm x43 cm (16.9" x 17.3") withrotatable detector carrierImage matrix size: 3008(H)pixel x 3072(V) pixelPixel size: 143 µm, with a pixeldepth of 14 bits | Different, butdoes notconcern safetyor efficacy |
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Detailed description of the main differences between X Twin and the predicate Essenta DR:
| Power consumption: | The power consumption of the X Twin is lower than of the predicateEssenta DR (24-44 kVA against 50-80 kVA).This means that the twin X has better energy efficiency. The X-Rayparameters are similar with the parameters of the Essenta DR, thereforethe difference does not concern safety or efficacy. |
|---|---|
| Columns: | The difference of both systems is that the X Twin contains two moveablecolumns and the Essenta DR has only one column.The columns of the X Twin are motorized, positioned on floor mountedguide frames. The column of the Essenta DR is fix floor or wall mounted.The advantage of the X Twin is a higher flexibility for the positioning ofthe system. Since the X-Ray imaging process is not affected from thisdifference, it does not concern safety or efficacy. |
| Tube and ReceptorMount: | The main difference in mounting the tube and the receptor is that thesecomponents are fixed on an adjustable U-arm at the Essenta DR. The XTwin uses separate arms, one for the tube and one for the receptor.This allows the occasionally necessary recording with a beam path whichis not aligned at 90° to the Receptor. The advantage of the X Twin is ahigher flexibility for the positioning of the system. Since the X-Rayimaging process is not affected from this difference, it does not concernsafety or efficacy. |
| Rotation Angle: | Both X-Ray systems have different rotation angles. The Essenta DR hasa rotation angle range of 165°, the X Twin has a rotation angle range of200° (applicable for standard images: 180°). The advantage of thisdifference is a higher flexibility for a wide range of examinations. Sincethe X-Ray imaging process is not affected from this difference, it doesnot concern safety or efficacy. |
| Total Weight: | The total weight of the X Twin is higher than the total weight of theEssenta DR (difference: 285 kg / 628.5lb). The reason for this differenceis the second column with the second arm and the floor mounted guideframes. Since these units are floor mounted, this difference does notconcern safety or efficacy. |
| Image Detector: | There are two differences between the used Image Detectors. The firstdifference is the active detector area. The Predicate Essenta DR uses a14" x 17" detector; the X Twin uses a 16.9″ x 17.3″ detector. This has the advantagethat even large organs such as thorax can be recorded on one image.The second difference is the higher pixel resolution (Predicate 182 um -X Twin 143 µm). This allows the creation of images with higherresolution. An illustration of finer tissue structures is thus more feasible.) |
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These main differences do concern safety or efficacy of the X Twin System neither individually nor in combination with each other.
Summary of Non-Clinical Performance Testing:
IEC 60601-1 IEC 60601-1-2 IEC 60601-1-3 Test clauses: 7.6 Test for half-value layer 8.5.2 Focal spot to image receptor distance 12.4 Leakage radiation IEC 60601-2-54 ISO 10993 Result of the biocompatibility Tests: There was no evidence found that the surfaces of the X Twin system may cause skin irritations or similar negative effects on the patient. The observed surface coatings are used on similar medical devices for 10 years, during this time was no case regarding skin irritation was known.
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices The documentation and testing of the X Twin Control Software was classified and performed as Moderate in accordance to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The documentation and testing of the Imaging Software DXRS was also performed in accordance to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. This software is part of the Image Detector DFP4343C7, therefore the software is already released (see K122589).
Reqarding the Image Detector DFP4343C7 a separate Non-Clinical performance testing was performed by NIPK Electron as 510(k) Applicant.
The performance testing was performed according to Section VI of the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. All test results were satisfactory.
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Summary of Clinical Performance Testing:
Roesys GmbH did not perform any clinical testing for the X Twin.
Regarding the Image Detector DFP4343C7 a Clinical Performance Testing was performed by NIPK Electron as 510(k) Applicant.
The performance testing was performed according to Section VII of the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.
All test results were satisfactory.
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Conclusion:
Roesys GmbH believes that the X Twin system is substantially equivalent to the currently legally marketed device. It does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
§ 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.