MULTIX Impact C is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact C 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 C is not intended for mammography.

MULTIX Impact C uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact C is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

Device Description

The MULTIX Impact C Radiography X-ray system is a modular system of x-ray components (ceiling suspension with x-ray tube, bucky wall stand, bucky table, x-ray generator, and portable wireless and fixed detectors) based on the predicate device, the MULTIX Impact (K193089). The detectors for the subject device, MULTIX Impact C, are the same as the detectors of the predicate device. The following modifications have been made to the predicate device:

1. New ceiling suspension with motorized tube tilting support for ortho function and new ceiling suspension with manual tube tilting
Modified automatic collimator 2.
1. New Bucky Wall Stand
Upgraded software version from VA11 to VA20 to support hardware modifications 4.
Modified patient table న్.
Modified touch user interface (TUI) 6.
Modified wireless remote-control console (WRCC) with new control design 7.

The new system will be branded as the MULTIX Impact C.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called MULTIX Impact C, which is a radiographic X-ray system. It describes the device, its intended use, and claims substantial equivalence to a predicate device (MULTIX Impact K193089).

However, the document focuses on demonstrating substantial equivalence through comparisons of technical characteristics and adherence to standards for the device itself (X-ray system), rather than providing details about an AI algorithm's performance or a clinical study that would involve acceptance criteria for such an algorithm. The MULTIX Impact C is designed to generate diagnostic images, but there is no mention of an AI component or software that interprets images or assists human readers in a diagnostic capacity.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and AI performance cannot be extracted from this document, as it describes a hardware-focused X-ray system rather than an AI-driven image analysis tool.

Here's a breakdown based on the information available in the provided text:

1. A table of acceptance criteria and the reported device performance

No acceptance criteria and reported device performance directly related to an AI algorithm's diagnostic output (e.g., sensitivity, specificity, AUC) are provided. The tests described are non-clinical performance and safety tests for the X-ray system hardware and associated software.

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, as no AI-specific test set or data provenance is mentioned. The testing described is for the X-ray system's hardware and software functionality, not for AI diagnostic performance.

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 no ground truth for an AI diagnostic algorithm's performance is established or discussed. The document mentions "operators are healthcare professionals familiar with and responsible for the x-ray examinations to be performed," but this refers to the users of the X-ray system, not experts establishing ground truth for AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no AI-specific test set or adjudication method is mentioned.

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. This document describes an X-ray imaging system, not an AI-assisted diagnostic tool that would typically undergo an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a radiographic X-ray system; there is no standalone algorithm performance described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. Ground truth for an AI diagnostic algorithm is not discussed. The "ground truth" for the device's performance would be its conformity to engineering specifications and safety standards, as demonstrated by non-clinical testing.

8. The sample size for the training set

Not applicable, as there is no mention of an AI model or a training set. The software mentioned (VA20) is an upgraded version to support hardware modifications and new control features, not an AI for image analysis.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of an AI model or a training set.

Summary of what is described regarding the device's "acceptance criteria" and testing:

The document indicates that the device (MULTIX Impact C X-ray system) meets its "acceptance criteria" through:

Non-clinical performance testing: "Non-clinical tests were conducted for the MULTIX Impact C during product development. The modifications described in this Premarket Notification are supported with verification and validation testing."
Adherence to Standards: The device conforms to numerous international and national standards, including:
- ES60601-1:2005/(R)2012 and A1:2012 (Medical electrical equipment – General requirements for basic safety and essential performance)
- IEC 60601-1-3:2008+A1:2013 (Medical electrical equipment – General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment)
- IEC 60601-1-2:2014 (Medical electrical equipment – General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests)
- IEC 62366-1:2015 (Medical devices – Application of usability engineering to medical devices)
- ISO 14971:2007 (Medical devices – Application of risk management to medical devices)
- IEC 60601-1-6:2013 (Medical electrical equipment – General requirements for basic safety and essential performance – Collateral Standard: Usability)
- IEC 62304:2015 (Medical device software – Software life cycle processes)
- IEC 60601-2-28:2017 (Medical electrical equipment – Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis)
- IEC 60601-2-54:2018 (Medical electrical equipment – Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy)
- NEMA PS 3.1-3.20 (2016) (DICOM standards)
- ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process)
Software Documentation and Testing: "Software Documentation for a Moderate Level of Concern software... 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 C during product development." All software specifications "met the acceptance criteria."
Risk Analysis: "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."
Substantial Equivalence: The primary "acceptance criterion" for clearance appears to be demonstrating substantial equivalence to a predicate device (MULTIX Impact K193089), which is achieved by showing similar indications for use, mechanical design, and that "non-clinical test data demonstrate that the MULTIX Impact C device performance is comparable to the predicate device."

In summary, the provided text is for the regulatory submission of an X-ray machine. It details the device's features, compliance with general safety and performance standards for X-ray equipment, and its similarity to a predicate device. It does not describe an AI diagnostic algorithm or a clinical study for such an algorithm's performance.

Summary

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January 6, 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

Siemens Medical Solutions USA, Inc. % Mr. Martin Rajchel Senior Regulatory Affairs Specialist 40 Liberty Blvd. Mail code: 65-1A MALVERN PA 19355

Re: K203340

Trade/Device Name: MULTIX Impact C Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: November 11, 2020 Received: November 12, 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) K203340

Device Name MULTIX Impact C

Indications for Use (Describe)

MULTIX Impact C is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact C 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, or in the prone position. MULTIX Impact C is not intended for mammography.

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 C

K203340

Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355

Date Prepared: November 11, 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 Sites

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 martin.rajchel(@siemens-healthineers.com

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3. Subject Device Name and Classification

Trade Name:	MULTIX Impact C
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 Devices:
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
Trade Name:	Multix Fusion Max
510(k) #:	K191418
Clearance Date:	June 19, 2019
Classification Name:	Stationary X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1680
Device Class:	Class II
Product Code:	KPR

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5. Device Description

1. New ceiling suspension with motorized tube tilting support for ortho function and new ceiling suspension with manual tube tilting
Modified automatic collimator 2.
1. New Bucky Wall Stand
Upgraded software version from VA11 to VA20 to support hardware modifications 4.
Modified patient table న్.
Modified touch user interface (TUI) 6.
Modified wireless remote-control console (WRCC) with new control design 7.

The new system will be branded as the MULTIX Impact C.

6. Indications for Use

Impact C is not intended for mammography.

MULTIX Impact C uses digital detectors for generating diagnostic images by converting Xrays into image signals. MULTIX Impact C is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

7. Substantial Equivalence

MULTIX Impact C is a modification of the predicate device, the MULTIX Impact (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 C 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

MULTIX Impact C is substantially equivalent to the commercially available predicate device, 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, collimator, patient table, detectors and imaging system).

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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 C with all its components, is substantially equivalent to the predicate device.

The modifications made to the subject device, MULTIX Impact C, 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).

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The following tables compare the main performance data of the subject device with the predicate device.

Attribute	MULTIX Impact C(Subject)	MULTIX ImpactK193089(Predicate)	ComparisonResults
Indicationsfor Use	MULTIX Impact C is aradiographic system used inhospitals, clinics, and medicalpractices. MULTIX Impact Cenables radiographic exposuresof the whole body including:skull, chest, abdomen, andextremities and may be used onpediatric, adult and bariatricpatients. Exposures may betaken with the patient sitting,standing, or in the proneposition. MULTIX Impact C isnot intended formammography.MULTIX Impact C uses digitaldetectors for generatingdiagnostic images byconverting X- rays into imagesignals.MULTIX Impact C is alsodesigned 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 is notmeant for mammography.The MULTIX Impact usesdigital detectors for generatingdiagnostic images byconverting X-rays into imagesignals.The MULTIX Impact is alsodesigned to be used withconventional film/screen orComputed Radiography (CR)cassettes.	Same(Minorgrammaticalchanges only)
Attribute	MULTIX Impact C(Subject)	MULTIX ImpactK193089(Predicate)	ComparisonResults
Tube Stand(TS)	Ceiling mounted manual TS- Manual tube tilting- Motorized tube liftingCeiling mounted motorized TS- Motorized tube tilting- Motorized tube lifting	Floor mounted semi motorizedTS- Manual tube tilting- Manual longitudinalmovement- Motorized tube lifting	Improved to supportmore operationalpossibilities.
	Hardware: Ortho SupportSoftware: three options as below	N.A.
Orthofunction(option)	Smart Ortho-Smart Virtual Ortho-Auto Full-Spine & Long--Leg Collimation	N.A.	New option to supportmore operationalpossibilities.
Collimator	Automatic collimator	Automatic collimator	Same
	N.A.	Manual collimator	New option
	Modified automatic collimator	N.A.
Bucky WallStand(BWS)	New BWS with motorized heightadjustment- 5 field AEC- Option for detector unit withmotorized lifting scope of315mm~1750mm- Detector unit with manualtilting	BWS with manual ormotorized height adjustment- 3 field AEC- Option for detector unit withmanual or motorized liftingscope of 330mm~1800mm	Improved to supportmore operationalpossibilities.
ImagingSystem	Detectors- Trixell MAX wi-D= Pixium3543EZh- iRay Core XL=Mars1717VS- iRay CoreStatic=Venu1717X	Detectors- Trixell MAX wi-D= Pixium3543EZh- iRay Core XL=Mars1717VS- iRay CoreStatic=Venu1717X	Same
	Software version: VA20	Software version: VA11	New software versionwith features like Orthofunction,SmartPositioning, andmodifications to support
Attribute	MULTIX Impact C(Subject)	MULTIX ImpactK193089(Predicate)	ComparisonResults
	User interface:- Operation Tabs are on thetop area	User interface:- Operation Tabs are on theright sidebar	Improved appearance ofuser interface.
Other minor modifications
Patient table	Elevating patient table with- 5 field AEC- Tray for wireless or fixeddetector	Fixed or elevating patient tablewith- 3 field AEC- Tray for wireless detector	Improved to supportmore operationalpossibilities.
Touch UserInterface(TUI)	Touch user interface- physical button withsoftware indicator- Modified user interface forOrtho function	Touch user interface- physical button withsilkscreen	Improved to supportmore operationalpossibilities.
WirelessRemoteControlConsole(WRCC)	Wireless Remote-ControlConsole (WRCC)- Collimation control- BWS lifting control- Enabled tracking- Tube stand motion (lifting)control- SmartPositioning button- Light localizer button	Wireless Remote-ControlConsole (WRCC)- Collimation control- BWS lifting control- Enabled tracking- Light localizer button	Improved to supportmore operationalpossibilities.

Table 1: Indications for Use Comparison:

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Table 2: Subject Device Compared to Predicate

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ProductFunction		MULTIX Impact C(Subject)	YSIO X.pree(K201670)(reference)	ComparisonResults
Hardware		Ortho Support(OrthoStand)	Ortho Support(OrthoStand)	Same
Software(optionallicensekeys)	Smart Ortho	Tilting Ortho: Ortho rangeset by adjusting collimatorand tube tilt manually	Tilting Ortho: Ortho rangeset by adjusting collimatorand tube tilt manually
	Smart VirtualOrtho	Ortho range set by 2Dcamera in the imagesystem manually	Ortho range set by 3Dcamera in the imagesystem manually	New option tosupport moreoperationalpossibilities.
	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

Table 3: Comparison of the Ortho function to the reference device

Table 4: Comparison of the Tube Stand to the reference device

Attribute	MULTIX Impact C(Subject)	Multix Fusion MaxK191418(reference)	ComparisonResults
Tube Stand(TS)	Ceiling mounted manual TS- Manual tube tilting- Motorized tube lifting	Ceiling mounted semi-motorized TS- Manual tube tilting- Motorized tube lifting	New option tosupport moreoperationalpossibilities.
	Ceiling mounted motorized TS- Motorized tube tilting- Motorized tube lifting

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9. Nonclinical Performance Testing

Non-clinical tests were conducted for the MULTIX Impact C during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.

MULTIX Impact C conforms to the following standards: ES60601-1:2005/(R)2012 and A1:2012: IEC 60601-1-3:2008+A1:2013: 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 C 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 C 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 C 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, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is 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 C 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 C performs as intended. The non-clinical test data demonstrate that the MULTIX Impact C device

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performance is comparable to the predicate device that is currently marketed for the same intended use.

In summary, Siemens concludes that the MULTIX Impact C 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 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

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Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: August 14, 2013

Regulation Number and Section

§ 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.