(55 days)
MULTIX Impact is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact is not intended for mammography.
MULTIX Impact uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
The MULTIX Impact (VA20) Radiography X-ray system is a modular system of x-ray components (floor-mounted x-ray tube, bucky wall stand, bucky table, x-ray generator, portable wireless and fixed detectors) based on the predicate device, the MULTIX Impact (K193089). The detectors for the subject device, MULTIX Impact (VA20), are the same as the detectors of the predicate device. The following modifications have been made to the predicate device:
- Modified tube stand (motorized) to support Ortho Function 1.
- Modified automatic collimator 2.
-
- New bucky wall stand
-
- Upgraded software version from VA11 to VA20 to support hardware modifications
- Modified patient table న్.
-
- Modified touch user interface (TUI)
- Modified wireless remote control console (WRCC) with new control design 7.
The modified system will be branded as the MULTIX Impact.
The provided text is a 510(k) summary for the Siemens MULTIX Impact X-ray system. It details modifications made to a previously cleared predicate device (MULTIX Impact K193089). This document does not include information about specific acceptance criteria or the study that proves the device meets those criteria in the typical sense of a clinical performance study with defined metrics like sensitivity, specificity, or reader performance.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. The "acceptance criteria" here are primarily conformity to recognized standards and successful completion of non-clinical verification and validation testing, ensuring the modified device performs as intended and introduces no new safety risks.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k) Submission) | Reported Device Performance (Summary from Submission) |
|---|---|
| Conformance to international and national standards (e.g., IEC 60601 series, ISO 14971, NEMA PS 3.1-3.20) | "MULTIX Impact (VA20) conforms to the following standards: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012; IEC 60601-1-3:2013; IEC 60601-1-2:2014; IEC 62366-1:2015; ISO 14971:2007; IEC 60601-1-6:2013; IEC 62304:2015; IEC 60601-2-28:2017; IEC 60601-2-54:2018; NEMA PS 3.1-3.20 (2016) and ISO 10993-1:2009." "All test results are a pass and support our claim of device safety and effectiveness." |
| Functional performance of modified components (e.g., tube stand, collimator, Bucky wall stand, software) | "Verification and validation testing have been successfully completed and test results show that the subject device, MULTIX Impact (VA20) with all its components, is substantially equivalent to the predicate device." "Non-clinical tests (integration and functional) were conducted on the MULTIX Impact (VA20) during product development." "The test results support that all the software specifications have met the acceptance criteria." |
| Software safety and effectiveness (Moderate Level of Concern) | "Software Documentation for a Moderate Level of Concern software... is also included... The performance data demonstrates continued conformance with special controls for medical devices containing software." "The risk analysis was completed, and risk controls were implemented to mitigate identified hazards." |
| Equivalence to predicate device in terms of indications for use, design, material, functionality, technology, and energy source. | "The MULTIX Impact (VA20) is substantially equivalent to the predicate device... The subject device is within the same classification regulation, has the same indications for use, and the same mechanical design as the predicate device." "The subject device uses the same or similar components cleared in the MULTIX Impact..." "The non-clinical test data demonstrate that the MULTIX Impact (VA20) device performance is comparable to the predicate device..." |
| Absence of new potential safety risks | "In summary, Siemens concludes that the MULTIX Impact (VA20) does not introduce any new potential safety risks..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a premarket notification for a modification to an existing X-ray system. The testing mentioned is primarily non-clinical verification and validation testing of hardware and software components against engineering specifications and regulatory standards. There is no mention of a "test set" in the context of clinical image data or patient studies from specific countries or whether they were retrospective/prospective. The assessment focuses on the performance of the system as a medical device, not a diagnostic algorithm.
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. As this is a 510(k) submission for an X-ray system, the "ground truth" (in the sense of expert-labeled medical images for an AI algorithm) is not relevant to the type of testing performed. The documentation focuses on engineering and regulatory compliance, not diagnostic accuracy of an AI component.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "test set" with expert adjudication is mentioned in the context of this 510(k) submission.
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. This 510(k) pertains to an X-ray imaging system itself, not an AI-powered diagnostic aide. Therefore, an MRMC study and effects on human reader performance are not described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not describe an AI algorithm or its standalone performance. The device is an X-ray system, which requires human operators.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The ground truth concept, as it relates to expert-labeled medical data for AI algorithms, is not part of this submission for an X-ray system itself. The "ground truth" for the engineering tests would be the design specifications and expected functional behavior of the components.
8. The sample size for the training set
Not applicable. This document does not describe an AI algorithm that undergoes training.
9. How the ground truth for the training set was established
Not applicable. This document does not describe an AI algorithm or its training process.
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January 7, 2021
Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. % Mr. Martin Rajchel Senior Regulatory Affairs Specialist 40 Liberty Blvd Mail code 65-1A MALVERN PA 19355
Re: K203345
Trade/Device Name: MULTIX Impact Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: November 12, 2020 Received: November 13, 2020
Dear Mr. Rajchel:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 mediation-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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K203345
Device Name MULTIX Impact
Indications for Use (Describe)
MULTIX Impact is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact is not intended for mammography.
MULTIX Impact uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
| 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)
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510(k) Summary: MULTIX Impact K203345
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
Date Prepared: November 12, 2020
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
1. General Information
Importer/ Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
Location of Manufacturing Site
Siemens Shanghai Medical Equipment Ltd. 278 Zhou Zhu Road Shanghai, 201318, China Establishment Registration Number: 3003202425
Siemens Healthcare GmbH Siemensstrasse 1 Forchheim, Germany 91301 Establishment Registration Number: 3004977335
2. Contact Person
Martin Rajchel Sr. Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 610-448-6545 martin.rajchel(@siemens-healthineers.com
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3. Subject Device Name and Classification
| Trade Name: | MULTIX Impact |
|---|---|
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
| Secondary Product Code: | MQB |
4. Legally Marketed Predicate Device
| Trade Name: | MULTIX Impact |
|---|---|
| 510(k) #: | K193089 |
| Clearance Date: | March 20, 2020 |
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
| Reference Device: | |
|---|---|
| Trade Name: | Ysio X.pree |
| 510(k)#: | K201670 |
| Clearance Date: | October 21, 2020 |
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
5. Device Description
The MULTIX Impact (VA20) Radiography X-ray system is a modular system of x-ray components (floor-mounted x-ray tube, bucky wall stand, bucky table, x-ray generator, portable wireless and fixed detectors) based on the predicate device, the MULTIX Impact (K193089). The detectors for the subject device, MULTIX Impact (VA20), are the same as the detectors of the predicate device. The following modifications have been made to the predicate device:
- Modified tube stand (motorized) to support Ortho Function 1.
- Modified automatic collimator 2.
-
- New bucky wall stand
-
- Upgraded software version from VA11 to VA20 to support hardware modifications
- Modified patient table న్.
-
- Modified touch user interface (TUI)
- Modified wireless remote control console (WRCC) with new control design 7.
The modified system will be branded as the MULTIX Impact.
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6. Indications for Use
MULTIX Impact is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact is not intended for mammography.
MULTIX Impact uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
7. Substantial Equivalence
The MULTIX Impact (VA20) is a modification of the predicate device, the MULTIX Impact, cleared via K193089. The subject device is within the same classification regulation, has the same indications for use, and the same mechanical design as the predicate device. The MULTIX Impact (VA20) is substantially equivalent to the predicate device and documentation is provided to support a claim of substantial equivalence.
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device
The MULTIX Impact (VA20) is substantially equivalent to the commercially available MULTIX Impact (K193089) in terms of the indications for use, design, material, functionality, technology, and energy source. The subject device uses the same or similar components cleared in the MULTIX Impact (e.g. tube, generator, detectors, collimator, BWS, patient table and imaging system).
The components of the subject device have many of the same technological characteristics as those in the predicate device. Some technological characteristics that differ slightly are shown in the comparison tables below. Verification and validation testing have been successfully completed and test results show that the subject device, MULTIX Impact (VA20) with all its components, is substantially equivalent to the predicate device.
The modifications made to the subject device, MULTIX Impact (VA20), do not affect the intended use of the device nor do they alter its fundamental scientific technology compared to the predicate device, the MULTIX Impact (K193089).
The following tables compare the main performance data of the subject device with the predicate device.
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Table 1: Indications for Use Comparison:
| Attribute | MULTIX ImpactVA20(Subject) | MULTIX ImpactK193089(Predicate) | ComparisonResults |
|---|---|---|---|
| Indicationsfor Use | MULTIX Impact is aradiographic system used inhospitals, clinics, and medicalpractices. MULTIX Impactenables radiographic exposuresof the whole body including:skull, chest, abdomen, andextremities and may be used onpediatric, adult and bariatricpatients.Exposures may be taken withthe patient sitting, standing, orin the prone position. MULTIXImpact is not intended formammography.MULTIX Impact uses digitaldetectors for generatingdiagnostic images byconverting X- rays into imagesignals. MULTIX Impact isalso designed to be used withconventional film/screen orComputed Radiography (CR)cassettes. | The MULTIX Impact systemis a radiographic system usedin hospitals, clinics, andmedical practices. MULTIXImpact enables radiographicexposures of the whole bodyincluding: skull, chest,abdomen, and extremities andmay be used on pediatric,adult and bariatric patients.Exposures may be taken withthe patient sitting, standing, orin the prone position. TheMULTIX Impact system isnot meant for mammography.The MULTIX Impact usesdigital detectors forgenerating diagnostic imagesby converting X-rays intoimage signals.The MULTIX Impact is alsodesigned to be used withconventional film/screen orComputed Radiography (CR)cassettes. | Same(Minorgrammaticalchanges only) |
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| Attribute | MULTIX Impact(VA20)(Subject) | MULTIX Impact (VA11)K193089(Predicate) | ComparisonResults |
|---|---|---|---|
| Tube Stand(TS) | Floor mounted semi-motorizedTS- Manual tube tilting- Manual longitudinalmovementFloor mounted fully motorizedTS- Manual tube tilting- Motorized tube lifting- Manual longitudinalmovement- Motorized tube tilting- Motorized longitudinal | Floor mounted semi-motorized TS- Manual tube tilting- Manual longitudinalmovement- Motorized tube lifting | SameImproved to support moreoperational possibilities. |
| Orthofunction(option) | Hardware: Ortho StandSoftware: three options- Smart Ortho- Smart Virtual Ortho- Auto Full-Spine & Long-Leg Collimation | N.A.N.A. | New option to supportmore operationalpossibilities. |
| Collimator | Manual collimator | Manual collimator | Same |
| Automatic collimator | Automatic collimator | Same | |
| Modified automatic collimator | N.A. | New option. | |
| Detector | - Trixell Pixium 3543EZH(MAX wi-D)- iRay Mars1717VS (Core XL)- iRay Venu1717X (CoreStatic) | - Trixell Pixium 3543EZH(MAX wi-D)- iRay Mars1717VS (CoreXL)- iRay Venu1717X (CoreStatic) | Same |
| Bucky WallStand(BWS) | New BWS with manual ormotorized height adjustment- 5 field AEC- Option for detector unit withmanual or motorized liftingscope of 315mm~1750mm | BWS with manual ormotorized height adjustment- 3 field AEC- Option for detector unitwith manual or motorizedlifting scope of330mm~1800mm | Improved to support moreoperational possibilities. |
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| Attribute | MULTIX Impact(VA20)(Subject) | MULTIX Impact (VA11)K193089(Predicate) | ComparisonResults |
|---|---|---|---|
| ImagingSystem | Software version: VA20 | Software version: VA11 | New SW version withfeatures like Orthofunction, SmartMove, andmodifications to supporthardware changes. |
| User interface:- Operation tabs are on thetop area | User interface:- Operation tabs are on theright sidebar | Improved user interface. | |
| Other minor modifications | |||
| Patient table | Elevating Patient table with- 5 field AEC | Fixed or elevating patienttable with- 3 field AEC | Improved to support moreoperational possibilities. |
| Touch UserInterface(TUI) | Touch user interface- Physical button withsoftware indicator- Modified user interface forOrtho function | Touch user interface- Physical button withsilkscreen | Improved to support moreoperational possibilities. |
| WirelessRemoteControlConsole(WRCC) | - Collimation control- BWS lifting control- Enabled tracking- Tube stand motion control- SmartMove button | - Collimation control- BWS lifting control- Enabled tracking | Improved to support moreoperational possibilities. |
Table 3: Comparison of Ortho function to reference device
| TechnicalSpecifications | MULTIX Impact(VA20)(subject) | Ysio X.pree(K201670)(reference) | Comparison Results |
|---|---|---|---|
| Otho Support | Accessory | Accessory | Same |
| Smart Ortho | Tilting Ortho: Orthorange set by adjustingcollimator and tube tilt | Tilting Ortho: Ortho rangeset by adjusting collimatorand tube tilt | Same |
| Smart VirtualOrtho | Ortho range set by 2Dcamera in image system | Ortho range set by 3Dcamera in image system | Similar clinical workflow. |
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| Auto Full-Spine& Long-LegCollimation | Otho range automaticallyplanned for Full-Spine &Long-Leg by 2D camerawith manual adjustment | Otho range automaticallyplanned for Thorax by 3Dcamera with manualadjustment | Similar clinical workflowfor different body parts. |
|---|---|---|---|
| ---------------------------------------------- | --------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------ | -------------------------------------------------------- |
9. Nonclinical Performance Testing
Non-clinical tests were conducted for the MULTIX Impact (VA20) during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.
MULTIX Impact (VA20) conforms to the following standards: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012; IEC 60601-1-3:2013; IEC 60601-1-2:2014; IEC 62366-1:2015; ISO 14971:2007; IEC 60601-1-6:2013; IEC 62304:2015; IEC 60601-2-28:2017; IEC 60601-2-54:2018; NEMA PS 3.1-3.20 (2016) and ISO 10993-1:2009.
All components of the x-ray system MULTIX Impact were tested and found adequate. All test results are a pass and support our claim of device safety and effectiveness.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005, is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted on the MULTIX Impact (VA20) during product development.
The risk analysis was completed, and risk controls were implemented to mitigate identified hazards. The test results support that all the software specifications have met the acceptance criteria. Verification and validation testing were found acceptable to support the claim of substantial equivalence.
General Safety and Effectiveness Concerns 10.
Instructions for use are included within the device labeling and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features, including visual and audible warnings, are incorporated into the system design. In addition, the MULTIX Impact (VA20) Radiography X-ray system is continually monitored and if an error occurs the system functions will be blocked and an error message will be displayed.
Risk management is ensured via a hazard analysis which is used to identify potential hazards. These potential hazards are controlled via software development, verification, and validation testing. To minimize electrical, and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is
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subject to final performance testing. Furthermore, the operators are healthcare professionals familiar with and responsible for the x-ray examinations to be performed.
11. Conclusion as to Substantial Equivalence
The MULTIX Impact (VA20) has the same indications for use as the predicate device, MULTIX Impact (K193089). The operating environment and mechanical design are similar.
Verification and validation testing demonstrate that the MULTIX Impact (VA20) performs as intended. The non-clinical test data demonstrate that the MULTIX Impact (VA20) device performance is comparable to the predicate device that is currently marketed for the same intended use.
In summary, Siemens concludes that the MULTIX Impact (VA20) does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device, MULTIX Impact (K193089).
12. Guidance documents
The following FDA guidance documents were utilized in the documentation of this Premarket Notification:
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: October 2, 2014
- Information to Support a Claim of Electromagnetic Compatibility (EMC) of . Electrically-Powered Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on July 11, 2016.
- Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance ● for Industry and Food and Drug Administration Staff Document issued on November 28, 2017.
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices ● Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016
- Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software contained in Medical Devices Document issued on: May 11, 2005
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for ● Medical Devices Guidance for Industry and Food and Drug Administration Staff
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Document issued on: September 14, 2018
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff Document issued on: July 28, 2014
- Radio Frequency Wireless Technology in Medical Devices Guidance for Industry . and Food and Drug Administration Staff Document issued on: August 14, 2013
§ 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.