Multix Fusion Max system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion Max 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. The Multix Fusion Max system is not meant for mammography.

Multix Fusion Max uses a mobile (wired), or a fixed (integrated) or wireless digital detector for generating diagnostic images by converting x-rays into image signals. The Multix Fusion Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

Device Description

The Multix Fusion Max 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, portable wireless and integrated detectors) which is the same as the predicate device, the Multix Fusion Max (K162971). The portable wireless and integrated detectors used with Multix Fusion Max are imported from the cleared predicate device, Multix Fusion Max (K162971). There are no new imaging detectors added to the subject x-ray system. The Multix Fusion Max software is being used unchanged from the reference device, Ysio Max (K181279). This 510(k) submission describes modifications to the predicate device, the Multix Fusion Max, cleared via K162971.

The purpose of this submission is for the following modifications to Multix Fusion Max:

Updated operating system from Windows 7 to Windows 10 and software version upgrade from VE21 to VF10
New cybersecurity features
Additional pediatric exposure technique factors
A new 80-line grid with a 15:1 ratio
The image processing algorithms (DiamondView MAX) will be used for exposures without grid
The Multix Fusion Max with VF10 has been tested according to the currently recognized voluntary standards.

AI/ML Overview

The provided document is a 510(k) summary for the Multix Fusion Max X-ray system. It describes modifications to an existing device (Multix Fusion Max, K162971) and claims substantial equivalence to that predicate device. The changes include an updated operating system (Windows 7 to Windows 10), software version upgrade, new cybersecurity features, additional pediatric exposure technique factors, and a new 80-line grid.

Crucially, this document does not contain information about a study that proves the device meets specific performance acceptance criteria for diagnostic accuracy, sensitivity, or specificity, especially not in the context of an AI-assisted diagnostic device or a multi-reader, multi-case study. The performance testing mentioned is primarily "non-clinical performance testing" for device functionality, safety (electrical, mechanical, radiation), and software verification/validation, rather than clinical performance for diagnostic effectiveness. The document states:

"Non-clinical tests were conducted for the Multix Fusion Max during product development. The modifications described in this Premarket Notification are supported with verification and validation testing."
"The testing results indicate that all the software specifications have met the acceptance criteria. Verification and validation testing was found acceptable to support the claim of substantial equivalence."
"The non-clinical test data demonstrate that the Multix Fusion Max device performance is comparable to the predicate device that is currently marketed for the same intended use."

The entire premise of the 510(k) submission for this device is to demonstrate substantial equivalence to a previously cleared device, not to prove new or improved clinical effectiveness through a diagnostic performance study. The device is a radiographic system for generating images, not an AI or CAD system that provides diagnostic interpretations or assists human readers in making diagnoses.

Therefore, many of the requested details about acceptance criteria for diagnostic performance, sample size for test sets (in a clinical sense), ground truth establishment, expert readers, MRMC studies, or standalone AI performance do not apply to the information presented in this 510(k) summary.

However, I can extract information related to what was studied to support the 510(k) clearance based on substantial equivalence.

Here's the closest answer based on the provided text, highlighting what is (and isn't) present:

Acceptance Criteria and Study for Multix Fusion Max (K191418)

The provided 510(k) summary for the Multix Fusion Max (K191418) focuses on demonstrating substantial equivalence to a predicate device (Multix Fusion Max, K162971) following modifications primarily related to software (operating system upgrade, cybersecurity), and minor hardware changes (new grid, expanded pediatric technique factors). The "study" described is a series of non-clinical verification and validation tests rather than a clinical diagnostic performance study. As such, many of the requested criteria related to AI or diagnostic accuracy studies are not applicable to the content of this document.

1. Table of Acceptance Criteria and Reported Device Performance

General acceptance criteria are related to safety, functionality, and compliance with standards. The document does not provide specific quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) for a clinical study of images, as this was not a submission for an AI/CAD device.

Aspect Tested	Acceptance Criteria	Reported Device Performance/Conclusion
Software Specifications	All software specifications must be met.	"The testing results indicate that all the software specifications have met the acceptance criteria."
Risk Analysis and Control (Hazards)	Identified hazards must be mitigated; device must not introduce new safety risks.	"The risk analysis was completed and risk controls were implemented to mitigate identified hazards." "Does not introduce any new potential safety risk."
Compliance with Voluntary Standards	Conformity to relevant standards (e.g., IEC 60601 series, ISO 14971, IEC 62304).	Device "conforms to the following standards: ES60601-1:2005/...; IEC 60601-1-2:2014...; IEC 60601-1-3...; IEC 62366-1...; ISO 14971...; IEC 62304...; IEC 60601-2-28...; IEC 60601-2-54...; PS 3.1 - 3.20 (2016) and ISO 10993-1..."
Electrical, Mechanical, and Radiation Hazards	Minimize hazards; comply with established industry practice.	"To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing."
Functional Equivalence to Predicate	Device performance comparable to predicate; same intended use.	"The Multix Fusion Max is substantially equivalent to and performs as well as the predicate device." "The non-clinical test data demonstrate that the Multix Fusion Max device performance is comparable to the predicate device that is currently marketed for the same intended use."
Software Documentation (Moderate Level of Concern)	Conformance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."	"Software Documentation for a Moderate Level of Concern software... is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software."
Verification and Validation Testing (Overall)	Demonstrated safety and effectiveness; supported claim of substantial equivalence.	"Verification and validation testing has been successfully completed and test results show that the subject device... is substantially equivalent to the predicate device." "Verification and validation testing was found acceptable to support the claim of substantial equivalence."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of a clinical test set of patient images for diagnostic accuracy. The testing performed was non-clinical verification and validation of system functionality and safety.
Data Provenance: Not applicable for a clinical test set. The document refers to its manufacturing sites in Shanghai, China, and Forchheim, Germany, and the applicant is Siemens Medical Solutions USA, Inc. The testing described is intrinsic to the device's engineering and software.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable as the submission describes non-clinical engineering and software validation, not a diagnostic performance study where human experts establish ground truth for image interpretation.

4. Adjudication Method for the Test Set

Not applicable for the type of non-clinical testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done or described in this 510(k) summary. This device is a basic X-ray system, not an AI or CAD system designed to assist human readers in diagnosis.

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

Not applicable. This device is an X-ray imaging system, not an AI algorithm intended for standalone diagnostic interpretation.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic image interpretation. For functional testing, "ground truth" would be established through engineering specifications, direct measurement, and known physical principles.

8. The Sample Size for the Training Set

Not applicable. This document describes a conventional X-ray system, not a machine learning or AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI/ML algorithm is described.

Summary

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Siemens Medical Solutions USA, Inc. Martin Rajchel Regulatory Affairs Specialist 40 Liberty Boulevard, Mailcode 65-1A MALVERN, PA 19355

Re: K191418

Trade/Device Name: Multix Fusion Max Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: May 24, 2019 Received: May 28, 2019

Dear Mr. Martin 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

June 19, 2019

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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 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-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@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)

K191418

Device Name Multix Fusion Max

Indications for Use (Describe)

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 Fusion Max

K191418

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

May 24, 2019 Date Prepared:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the 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, China 201318 Establishment Registration Number: 3003202425

Siemens Healthcare GmbH, Business Unit XP Siemensstrasse 1 Forchheim, Germany 91301 Establishment Registration Number: 3004977335

2. Contact Person

Martin Rajchel 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. Device Name and Classification

Trade Name:	Multix Fusion Max
Classification Name:	Stationary X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1680
Device Class:	Class II
Product Code:	KPR

4. Legally Marketed Predicate Device

Trade Name:	Multix Fusion Max
510(k) #:	K162971
Clearance Date:	November 22, 2016
Classification Name:	Stationary X-Ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1680
Device Class:	Class II
Product Code:	KPR
Reference Device:
Trade Name:	Ysio Max
510(k) #:	K181279
Clearance Date:	June 13, 2018
Classification Name:	Stationary X-Ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1680
Device Class:	Class II
Product Code:	KPR

5. Device Description

The purpose of this submission is for the following modifications to Multix Fusion Max:

Updated operating system from Windows 7 to Windows 10 and software version upgrade ● from VE21 to VF10
New cybersecurity features
Additional pediatric exposure technique factors

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A new 80-line grid with a 15:1 ratio ●
. The image processing algorithms (DiamondView MAX) will be used for exposures without grid
The Multix Fusion Max with VF10 has been tested according to the currently recognized voluntary standards.

6. Indication for Use

7. Substantial Equivalence

The Multix Fusion Max is a modification to the predicate device, Multix Fusion Max, cleared via K 162971. The Multix Fusion Max utilizes the same operating system and same software version as the reference device, the Ysio Max, cleared via K181279. Multix Fusion Max is within the same classification regulation, has the same indications for use, and the same mechanical design as the predicate device. The Multix Fusion Max 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 Fusion Max is substantially equivalent to the commercially available predicate device, the Multix Fusion Max (K162971) in terms of design, materials, functionality, technology, and energy source. The indications for use is the same as the commercially available predicate device, Multix Fusion Max (K162971). The subject device uses the same components cleared in the Multix Fusion Max (e.g. tube, generator, ceiling-mounted tube support, table, bucky wall stand, detectors, and imaging system).

The components of the subject device have many of the same technological characteristics as the ones from the predicate device. There are some technological characteristics that differ slightly as shown in the comparison tables below. Verification and validation testing has been successfully completed and test results show that the subject device. Multix Fusion Max. with all of its components, is substantially equivalent to the predicate device.

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The modifications made to the subject device, Multix Fusion Max, do not affect the intended use of the device, nor do they alter its fundamental scientific technology compared to the predicate device.

The following tables compare the main attributes of the subject device to the predicate device:

	Multix Fusion Max(Subject)	Multix Fusion MaxK162971(Predicate)	ComparisonResults
Indications forUse	Multix Fusion Maxsystem is a radiographicsystem used in hospitals,clinics, and medicalpractices. Multix FusionMax enablesradiographic exposuresof the whole bodyincluding: skull, chest,abdomen, and extremitiesand may be used onpediatric, adult andbariatric patients.Exposures may be takenwith the patient sitting,standing, or in the proneposition.The Multix Fusion Maxsystem is not meant formammography.Multix Fusion Max usesa mobile (wired), or afixed (integrated) orwireless digital detectorfor generating diagnosticimages by converting x-rays into image signals.The Multix Fusion Max	Multix Fusion Max systemis a radiographic systemused in hospitals, clinics,and medical practices.Multix Fusion Max enablesradiographic exposures ofthe whole body including:skull, chest, abdomen, andextremities and may be usedon pediatric, adult andbariatric patients. Exposuresmay be taken with thepatient sitting, standing, orin the prone position.The Multix Fusion Maxsystem is not meant formammography.Multix Fusion Max uses amobile (wired), or a fixed(integrated) or wirelessdigital detector forgenerating diagnostic imagesby converting x-rays intoimage signals. The MultixFusion Max is also designedto be used with conventionalfilm/screen or Computed	Same

Table 1: Comparison of the Subject Device Multix Fusion Max to the Predicate – Indications for Use

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	is also designed to beused with conventionalfilm/screen or ComputedRadiography (CR)cassettes.	Radiography (CR) cassettes.
--	---------------------------------------------------------------------------------------------------------------	-----------------------------	--

Table 2: Subject Device, Multix Fusion Max Attributes Compared to the Predicate

Attribute	Multix Fusion Max(Subject)	Multix Fusion MaxK162971(Predicate)	ComparisonResults
Operatingsystem	Windows 10	Windows 7	New operatingsystem, doesnot affect safetyor effectiveness
Digitalimagingsystem(unchanged)	Fluorospot Compact	Fluorospot Compact	Same
Cybersecurity	Security package based onMS Win 10	Security package based onMS Win 7	Improvedsecuritypackage for thenew operatingsystem
Ceilingmountedsupport(unchanged)	Semi-automated	Semi-automated	Same
X-ray tubeassembly(unchanged)	80 kWTwo-focus	80 kWTwo-focus	Same
Collimator(unchanged)	Standard collimator(ACSS)	Standardcollimator(ACSS)	Same
PatientTable(unchanged)	Radiographic tablemotorized with floatingtable top with charging intray (wireless detector)	Radiographic tablemotorized with floatingtable top with charging intray (wireless detector)	Same
	Radiographic tablemotorized with floatingtable top (integrateddetector)	Radiographic tablemotorized with floatingtable top (integrateddetector)	Same
Bucky WallStand (BWS)(unchanged)	BWS for integrateddetector motorized heightadjustment (verticalmovement)	BWS for integrateddetector motorized heightadjustment (verticalmovement)	Same
	BWS for wireless detectormotorized heightadjustment (verticalmovement)	BWS for wireless detectormotorized heightadjustment (verticalmovement)	Same
TouchInterface(unchanged)	Graphical user interface	Graphical user interface	Same
X-raygenerator(unchanged)	55kW, 65 kW or 80 kW	55kW, 65 kW or 80 kW	Same
IntegrateddetectorTRIXELL(unchanged)	Pixium 4343RCE= MaxStatic43 cm x 43 cm	Pixium 4343RCE= MaxStatic43 cm x 43 cm	Same
PortableWirelessDetectorTRIXELL(unchanged)	Pixium 3543EZh=Max Wi-D43 cm x 35 cmPixium 2430EZ= MaxMini30 cm x 24 cm	Pixium 3543EZh=MaxWi-D43 cm x 35 cmPixium 2430EZ= MaxMini30 cm x 24 cm	Same
Operatingmodes(unchanged)	RAD Single Exposure	RAD Single Exposure	Same
ImagingSystem(unchanged)	Fluorospot Compact PCbased,high res digital	Fluorospot Compact PCbased,high res digital	Same
Display 19"	Color	Black & Whiteor Color	Different, doesnot affect safetyor effectiveness
DICOM 3Functions	Send, StC, Print,	Send, StC, Print,	Same
(unchanged)	Query/Retrieve, Get	Query/Retrieve, Get
	Worklist, MPPS	Worklist, MPPS
	RadiographicGrid	92-line grid(ratio 13:1)85-line grid(ratio 5:1) (optional)80-line grid(ratio 15:1)(optional)	92-line grid(ratio 13:1)85-line grid(ratio 5:1) (optional)
Accessory(unchanged)	Remote Controlconsole	Remote Controlconsole	Same
Imageprocessing	DiamondView MAX	Diamond View Plus	Same(brand namechange only)
Pediatricpackage	Increased number of organprograms	Organ programs	Increasednumber andvariability

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9. Nonclinical Performance Testing

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

Multix Fusion Max conforms to the following standards: ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012; IEC 60601-1-2:2014 ed. 4.0 2014-02; IEC 60601-1-3 Edition 2.1 2013-04; IEC 62366-1 Edition 1.0 2015-02; ISO 14971 Second edition 2007-03-01; IEC 60601-1-6 Edition 3.1 2013-10; IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION; IEC 60601-2-28 Edition 3.0 2017-06; IEC 60601-2-54 CONSOLIDATED VERSION Edition 1.1 2015-04; PS 3.1 - 3.20 (2016) and ISO 10993-1 Fourth edition 2009-10-ાર :

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

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performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted on the Multix Fusion Max during product development.

The risk analysis was completed and risk controls were implemented to mitigate identified hazards. The testing results indicate that all the software specifications have met the acceptance criteria. Verification and validation testing was found acceptable to support the claim of substantial equivalence.

10. General Safety and Effectiveness Concerns

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 Fusion Max 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 Fusion Max has the same indications for use as the predicate device, Multix Fusion Max (K162971). The operating environment and mechanical design are similar. It is Siemens' opinion that the Multix Fusion Max is substantially equivalent to the Multix Fusion Max, cleared in K162971, November 22, 2016.

The predicate device was cleared based on non-clinical supportive information. Therefore, the subject device non-clinical data supports the safety of the device with verification and validation testing. Verification and validation testing demonstrates that the Multix Fusion Max performs as intended. The non-clinical test data demonstrate that the Multix Fusion Max device performance is comparable to the predicate device that is currently marketed for the same intended use.

In summary, Siemens is of the opinion that the Multix Fusion Max does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate device.

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12. Guidance documents

The following FDA guidance documents were utilized in 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
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.