The Cios Select is a mobile X-ray system intended for use in Operating room. Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.

The Cios Select can operate in four different modes, Digital Radiography, and Pulsed Fluoroscopy and Cassette exposure which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of a intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Device Description

This 510(k) submission, Cios Select (VA21) is a Mobile C-arm X-ray System. The Cios Select (VA21) is a modification of the Cios Select originally cleared under Premarket Notification K153232 on February 10, 2016.

The Cios Select consists of two major units:

One is the acquisition unit with the C-arm and movable base containing the generator, power unit, system control, and tube housing assembly on one side of the C-arm and the image intensifier on the opposite side.

The second unit is the image display station with a moveable trolley for the image processing and storage system, image display and documentation. Both units are connected to each other with a cable. The main unit is connected to the main power outlet and the trolley is connected to a data network.

AI/ML Overview

The provided text is a 510(k) summary for the Cios Select (VA21) Image Intensifier, which describes modifications to an existing mobile X-ray system. The document focuses on demonstrating substantial equivalence to predicate devices through verification and validation of these modifications. It primarily references non-clinical performance testing and compliance with various standards.

Here's a breakdown of the requested information based on the provided text:

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

The document does not provide a specific table of quantitative acceptance criteria and corresponding reported device performance values in the way one might expect for a diagnostic AI device. Instead, it details that the device underwent non-clinical performance testing to ensure compliance with several industry standards and regulations.

Acceptance Criteria Category	Reported Device Performance (Summary)
Software Functionality	All software specifications met acceptance criteria. Software verification and regression testing performed successfully, meeting previously determined acceptance criteria in test plans.
Electrical Safety	Complies with AAMI ANSI ES60601-1:2005/(R)2012, IEC 60601-1, IEC 60601-2-43, IEC 60601-2-54.
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2:2014 and IEC 60601-1-2.
Radiation Control	Complies with 21 CFR 1020.30 (c, e, g, h, k, m), 1020.31(a), 1020.32 (a, b, c, d, g, j, k), and 1040.10.
Risk Management	Risk analysis completed, and risk controls implemented to mitigate identified hazards.
Cybersecurity	Conforms to cybersecurity requirements by implementing a process to prevent unauthorized access, modifications, misuse, or denial of use. A cybersecurity statement considering IEC 80001-1:2010 is provided.
Overall Safety & Effectiveness	Testing results support that all software specifications met acceptance criteria. Verification and validation found acceptable to support claims of substantial equivalence. All conducted testing found acceptable and do not raise any new safety or effectiveness issues.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses non-clinical performance testing and mentions "Bench test Summaries and System Verification and Validation testing." There is no mention of a "test set" in the context of clinical images or data provenance (country of origin, retrospective/prospective). The evaluations were primarily conducted in a laboratory or manufacturing setting.

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. This submission relies on engineering and regulatory compliance testing rather than clinical expert review of images for ground truth establishment.

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

Not applicable. As noted above, this submission does not involve a test set requiring expert adjudication for ground truth.

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 study was mentioned. The device is an image intensifier system, not an AI-powered diagnostic aid that assists human readers.

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

This refers to an X-ray imaging system, not an algorithm. The "standalone" performance refers to the system's ability to operate according to its specifications and regulatory standards. The documentation indicates that "Performance tests were conducted to test the functionality of Cios Select (VA21) System," implying standalone performance evaluation of the device itself.

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

For the non-clinical testing, the "ground truth" is defined by the technical specifications outlined in the various industry standards (e.g., IEC, AAMI) and regulatory requirements (e.g., 21 CFR sections) to which the device was tested for compliance.

8. The sample size for the training set

Not applicable. The document describes an X-ray imaging device and its software modifications, not a machine learning or AI algorithm that requires a "training set."

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

Not applicable, as no training set for a machine learning algorithm is discussed in the provided text.

Summary

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March 4, 2021

Image /page/0/Picture/1 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solutions USA, Inc. % Cordell Fields, Esq. Sr. Regulatory Affairs Specialist 40 Liberty Boulevard 65-1A MALVERN PA 19355

Re: K210307

Trade/Device Name: Cios Select (VA21) Image Intensifier Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: January 28, 2021 Received: February 3, 2021

Dear Cordell Fields:

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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 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) K210307

Device Name Cios Select (VA21) Image Intensifier

Indications for Use (Describe)

The Cios Select is a mobile X-ray system intended for use in Operating room. Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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SIEME Healthinee

510(k) Summary: Cios Select

K210307

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

Date Prepared: January 28, 2021

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 Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869

Manufacturing Site:

Siemens Shanghai Medical Equipment Ltd. 278 Zhou Zhu Road, Shanghai 201318. China Establishment Registration Number: 3003202425

Contact Person: 2.

Cordell Field, Esq. Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 306-3167 Email: cordell.fields@siemens-healthineers.com

3. Device Name and Classification:

Trade Name: Classification Name: Classification Panel: Requlation Number: Device Class: Product Codes:

Cios Select (VA21) Image-Intensifier

Image-Intensified Fluoroscopic X-Ray System Radiology 21 CFR §892.1650 Class II OWB, OXO, JAA

4. Legally Marketed Primary Predicate Device
Trade Name:	Cios Select
510(k) Clearance	K153232
Clearance Date	February 10, 2016
Classification Name:	Image-Intensified Fluoroscopic X-Ray SystemMobile
Classification Panel:	Radiology

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Requlation Number: Device Class: Product Code: Total Product Life Cycle: this cleared device.

21 CFR §892.1650 Class II OXO, OWB, JAA There are no Recalls nor MDR incidents for

Legally Marketed Secondary Predicate Device
Trade Name:	Cios Select
510(k) Clearance	K181767
Clearance Date	August 17, 2018
Classification Name:	Image-Intensified Fluoroscopic X-Ray System,Mobile
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1650
Device Class:	Class II
Product Code:	OXO, OWB, JAA
Total Product Life Cycle:	All product Recall incidents are consideredduring the Design Input phase of developmentto ensure the latest models will not be affectedby any of the applicable issues.

Device Description: 5.

The Cios Select consists of two major units:

The following modifications were made to the Predicate Device the Cios Select Mobile X-ray System cleared under Premarket Notification K153232 on February 10, 2016. Siemens Medical Solutions USA, Inc. submits this Special 510(k) to request clearance for the Subject Device the Cios Select (VA21). The following minor modifications are incorporated in the Primary Predicate Device to create the Subject Device, for which Siemens is seeking 510(k) clearance:

The following modifications have been made to the Subject Device in comparison to the Predicate Device:

Upgraded software version to VA21 1)
- A. Updated Image storage to a maximum of 300000 frames

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B. Upgraded to Windows 10
C. Enhanced Cybersecurity
D. Optional WLAN for wireless transmission of DICOM Data
Optional Wireless Footswitch 2)
1. New Image Intensifier

6. Indications for Use:

The Cios Select is a mobile x-ray system intended for use in Operation room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. The Cios Select can operate in four different modes, Digital Radiography, Fluoroscopy and Pulsed Fluoroscopy and Cassette exposure which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

7. Substantial Equivalence:

The Cios Select (VA21) system is within the same classification regulation with the same indications for use as the legally marketed predicates listed in Table 1 below:

Predicate Device Name andManufacturer	510(k)Number	ClearanceDate	Comparable Properties
Primary PredicateCIOS Select (VA10) w/ImageIntensiferSiemens Shanghai MedicalEquipment Ltd.	K153232	02/10/2016	● Indications for use● X-ray technology● Image processing● Mechanical design● Image Intensifier● Cybersecurity● Software
Predicate DeviceCIOS Select (VA20) w/FlatPanel DetectorSiemens Shanghai MedicalEquipment Ltd.	K181767	8/17/2018	● OTS Software Windows 10● WLAN for Network● Wireless Footswitch

Table 1: Predicate Device Comparable Properties for Subject Device Modifications:

8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:

The Indications for Use Statement is exactly the same as the cleared Primary Predicate Device "Cios Select" VA10 (K153232).

The Cios Select with system software VA21 contains the following minor modifications that were made to the primary predicate device. Provided in Table 2 is a summary of comparison of Technological Characteristics to Predicate Devices.

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	Subject DeviceCios Select (VA 21) SystemModifications	Primary Predicate DeviceCios Select (VA10)K153232	ComparisonResults
1.	Upgraded software to VersionVA21A. Updated Image storage to amaximum of 300000 framesB. Upgraded to Windows 10C. Enhanced Cybersecurity	Software Version VA10Image storage to a maximumof 150,000 framesWindows 7 SoftwareCybersecurity	Comparable: System Softwareupgraded to VA21 to supportnew software and hardwaremodifications 1 A-C which arecomparable to the PrimaryPredicate Device. Softwareversion VA21 supportsadditional image storage,Windows (OTS) softwareupgrade to Windows 10 andenhanced Cybersecurity. Thereare no new functionalities whencompared to the PrimaryPredicate Device Cios Select(VA10) K153232. Tested perSoftware and OTS Softwareguidance requirements anddoes not raise any new safety oreffectiveness issues.
	D. Optional WLAN for wirelesstransmission of DICOM Data	Predicate DeviceCios SelectK181767Optional WLAN for wirelesstransmission of DICOM Data	Same: These features are theexact same features cleared inthe Secondary PredicateDevice Cios Select (VA20)K181767 and does not raise anynew safety or effectivenessissues.
2.	Optional Wireless Footswitch	Optional Wireless Footswitch
3.	New Image intensifier	Primary Predicate DeviceCios Select (VA10)K153232Image intensifier	Comparable: The new ImageIntensifier does not raise anynew safety or effectivenessissues. There are no newfunctionalities when comparedto the Primary PredicateDevice Cios Select (VA10)K153232.

Table 2: Summary of Comparison of Technological Characteristic

9. Nonclinical Performance Testing:

Non-clinical tests were conducted for the Cios Select (VA21) during product development. The Siemens Cios Select has been tested to meet the requirements for conformity to multiple industry standards. Performance testing confirmed, that the Siemens Cios Select complies with the following 21 CFR Federal Performance Standards

Code of Federal Regulations Title 21 Subchapter J- Radiological Health, applicable sections include:

1020.30(c) Manufacturer's Responsibility (Certification) ●
1020.30(e) Identification of X-ray components
1020.30(g) Information to be provided to assemblers
1020.30(h) Information to be provided to users ●
1020.30(k) Leakage Radiation ●
1020.30(m) Beam Quality ●

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1020.31(a) Peak Tube Potential ●
. 1020.32(a) Primary Protective Barrier Transmission
1020.32(b) Alignment of edges of the X-ray field with the edges of ● the fluoroscopic image receptor
1020.32(c) Activation of tube. ●
1020.32(d) Fluoroscopic Entrance exposure rate ●
1020.32(g) Source-skin distance .
1020.32(j) Display of last-image-hold (LIH)
1020.32(k) Display of values of AKR and cumulative air kerma
1040.10 Laser products

The Cios Select (VA 21) was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards for Electrical safety, performance and Electromagnetic Compatibility:

AAMI ANSI ES60601-1:2005/(R)2012 ●
IEC 60601-1-2:2014
. IEC 60601-1-3:2013
IEC 60601-1-6:2010/A1:2013 ●
IEC 60825-1:2014 ●
TR 60878:2015 ●
IEC 62304:2015 ●
IEC 80001-1:2010 ●
IEC 60601-2-28:2017 ●
IEC 60601-2-43:2017 ●
IEC 60601-2-54:2009/A1:2015 ●
ISO 14971:2019
IEC 62366-1:2015 ●

Table 3: FDA Guidance Documents

FDA Guidance Documents and Effective Date
1.	Guidance for Industry and Food and Drug Administration Staff: User Fees and Refundsfor Premarket Notification Submissions 510(k).	Document issued on October 2, 2017
2.	Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policyfor 510(k)s.	Document issued on January 30, 2018
3.	Guidance for Industry and Food and Drug Administration Staff: The Special 510(k)Program - Guidance for Industry and FDA Staff.	Document issued on September 13, 2019
4.	Guidance for Industry and Food and Drug Administration Staff: Deciding when to submita 510(k) for a change to an existing device.	Document issued on October 25, 2017
5.	Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program:Evaluating Substantial Equivalence in Premarket Notifications [510(k)].	Document Issued on July 28, 2014

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FDA Guidance Documents and Effective Date
6.	Guidance for Industry and Food and Drug Administration Staff: Guidance for the Contentof Premarket Submission for Software in Medical Devices.Document issued on May 11, 2005
7.	Guidance for Industry and Food and Drug Administration Staff: Guidance for Off-The-Shelf Software Use in Medical Devices.Document issued on September 9, 1999
8.	Guidance for Industry and Food and Drug Administration Staff: Pediatric Information forX-ray Imaging Device Premarket Notifications.Document issued on November 28, 2017
9.	Guidance for Industry and Food and Drug Administration Staff: Content of PremarketSubmissions for Management of Cybersecurity in Medical devices.Document issued on October 2, 2014
10.	Guidance for Industry and Food and Drug Administration Staff: Radio FrequencyWireless Technology in Medical Device.Document issued on August 14, 2007.
11.	Guidance for Industry and Food and Drug Administration Staff: Information to Support aClaim of Electromagnetic Compatibility (EMC) of Electrically-Powered MedicalDevices.Document issued on July 11, 2016

The modifications described in this Premarket Notification are supported with Bench test Summaries and System Verification and Validation testing.

Verification and Validation:

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 and "Off-The-Shelf Software Use in Medical Devices" 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 were conducted on the Subject Device Cios Select software version VA21 during product development.

The Risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

Bench testing in the form of Unit. Subsystem and System Integration testing was performed to evaluate the performance and functionality of the new features, hardware, and software updates. All testable requirements in the Engineering Requirements Specifications keys, Subsystem Requirements Specifications keys, and the Risk Management Hazard kevs have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.

Electrical safety and EMC testing were conducted on the Cios Select, consisting of the acquisition unit (C-arm system) and the image processing and display station.

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The system complies with the IEC 60601-1, IEC 60601- 2-43 and IEC 60601-2-54 standards for safety and the IEC 60601-1-2 standard for EMC.

The Cios Select software (VA21) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. Customer employees are adequately trained in the use of this equipment.

Siemens conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. The responsibility for compliance with IEC 80001-1-2010 is the hospital. Provided in the Software Section, is the required cybersecurity information.

Summary:

Performance tests were conducted to test the functionality of Cios Select (VA21) System. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable and do not raise any new issues of safety or effectiveness.

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.

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 health care professionals familiar with and responsible for the evaluating and post processing of X-ray images.

11. Conclusion as to Substantial Equivalence:

The predicate devices were cleared based on non-clinical supportive information and clinical images and data. Similar non-clinical test results demonstrate that the Cios Select (VA21) System acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristics, non-clinical performance data and software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Devices that is currently marketed for the same intended use.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.