The digital mammography system MAMMOMAT B.brilliant is intended to be used for mammography exams, screening, diagnosis, biopsies and dual energy procedures under the supervision of medical professionals. Mammography images can be interpreted by either hard copy film or soft copy workstation.

With Biopsy Option: The InSpect feature for MAMMOMAT B.brilliant with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure.

Device Description

MAMMOMAT B.brilliant is a floor-mounted, full field digital mammography system for screening, diagnostic, and biopsy procedures on standing, seated, or recumbent patients.

The system consists of an examination stand with x-ray generator, a gantry with tube housing assembly, and mammography support table, including detector and an acquisition workstation with a radiation shield. The MAMMOMAT B.brilliant comes with a variety of compression plates and a biopsy attachment for diagnostic adjunct procedures.

The MAMMOMAT B.brilliant features an updated detector, a new image acquisition chain (tube, filter, collimator) and improvements to the image acquisition workflow and biopsy workflow. Adaptations have been made to the image processing due to the new image acquisition hardware and the Soft- and hardware feature improvements. Patient positioning features like a head rest have been added.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MAMMOMAT B.brilliant device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Objective	Acceptance Criteria	Reported Performance
Detector characteristics	Ensure non-inferiority to predicate	Same or better than predicate	Passed
Dual energy imaging	Ensure non-inferiority to predicate	Same or better than predicate	Passed
Targeting accuracy	Ensure accuracy of the biopsy device	The needle tip must be no more than +/- 1 mm in x, y, z direction from the selected target point	Passed
Biopsy images	Ensure non-inferiority to predicate	Same or better than predicate	Passed
PRIME	Ensure non-inferiority to predicate	Same or better than predicate	Passed
Clinical Image Evaluation	Acceptable quality for mammographic usage	All image sets to be of acceptable overall clinical image quality (determined by expert radiologists)	Passed (All image sets found acceptable)

2. Sample Sizes Used for Test Set and Data Provenance

Clinical Image Evaluation Test Set: 19 FFDM cases
- 4 cases with biopsy
- 2 cases with PRIME
- 3 cases with contrast-enhanced mammography (TiCEM)
- 3 of the above cases included magnification views.
Data Provenance: Not explicitly stated regarding the origin (e.g., country) or whether it was retrospective or prospective. It is implied to be a Siemens-conducted study.

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

Number of Experts: 3 expert readers.
Qualifications: "Expert radiologists." No further specific qualifications (e.g., years of experience) are provided in the document.

4. Adjudication Method for the Test Set

The document implies a consensus-based approach for the clinical image evaluation, stating, "The radiologists found all image sets to be of acceptable overall clinical image quality." However, a specific adjudication method like "2+1" or "3+1" is not detailed. It suggests independent review followed by a collective judgment of acceptability.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers' improvement with AI vs. without AI assistance was not reported. The clinical image evaluation was to determine if images from the new device (MAMMOMAT B.brilliant) were of acceptable quality and substantially equivalent to the predicate device, not to evaluate AI assistance for human readers.

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

No, a standalone algorithm performance study was not explicitly reported as a primary clinical test for this submission. The clinical image evaluation focused on the overall image quality generated by the device for interpretation by human radiologists. The device itself (MAMMOMAT B.brilliant) is a mammography system, not primarily an AI-driven image analysis algorithm in the context of this submission.
- Note: While the device utilizes "Image processing algorithms," the clinical evaluation was on the output images for human interpretation, not on the algorithm's standalone diagnostic performance.

7. The Type of Ground Truth Used

Clinical Image Evaluation: Expert consensus (judgment of "acceptable overall clinical image quality" by 3 expert radiologists).
Targeting Accuracy: Physical measurement against a phantom and calibration needle.

8. The Sample Size for the Training Set

The document does not specify a training set size or provide details about a training set for any AI/software components within the device. The clinical evaluation focuses on comparing the new device's images to the predicate and determining acceptability, not on performance of a trained AI diagnostic algorithm.

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

As no training set is described for an AI diagnostic algorithm, this information is not applicable and is not provided in the document. The document primarily concerns the hardware and basic image processing of a mammography system.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

March 27, 2024

Siemens Medical Solutions USA, Inc. Denise Adams Regulatory Affairs Professional 40 Liberty Boulevard MALVERN, PA 19355

Re: K233539

Trade/Device Name: MAMMOMAT B.brilliant Regulation Number: 21 CFR 892.1715 Regulation Name: Full-Field Digital Mammography System Regulatory Class: Class II Product Code: MUE Dated: February 23, 2024 Received: February 23, 2024

Dear Denise Adams:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming

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product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K233539

Device Name

MAMMOMAT B.brilliant

Indications for Use (Describe)

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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510(k) Summary: MAMMOMAT B.brilliant (K233539)

Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355

Date Prepared: March 27, 2024

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 Malvern, PA 19355 Establishment Registration Number: 2240869

Location of Manufacturing Site

Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335

2. Contact Person:

Denise Adams, RAC Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA adams.denise@siemens-healthineers.com

Alternate Contact Person:

Martin Rajchel Sr. Manager, Requlatory Affairs Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA martin.rajchel@siemens-healthineers.com

3. Device Name and Classification:

Trade Name: MAMMOMAT B.brilliant Full Field Digital, System, X-Ray Mammographic Classification Name: Classification Panel: Radiology Classification Regulation: 21 CFR § 892.1715 Device Class: Product Code: MUE

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4. Legally Marketed Predicate Device

Trade Name:	MAMMOMAT Revelation
510(k) #:	K193166
Classification Name:	Full Field Digital, System, X-Ray Mammographic
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1715
Device Class:	II
Product Code:	MUE

5. Device Description:

MAMMOMAT B.brilliant is a floor-mounted, full field digital mammography system for screening, diagnostic, and biopsy procedures on standing, seated, or recumbent patients.

6. Indications for Use:

The digital mammography system MAMMOMAT B.brilliant is intended to be used for mammography exams, screening, diagnosis, biopsies and dual energy procedures under the supervision of medical professionals. The Mammography images can be interpreted by either hard copy film or soft copy workstation.

7. Substantial Equivalence:

The Siemens MAMMOMAT B.brilliant with VA10 is substantially equivalent to the commercially available Siemens MAMMOMAT Revelation with VC20 (K193166).

Table 1: Comparison of the Subject to the Primary Predicate

Attributes	Predicate deviceMAMMOMATRevelation VC20,K193166	Subject deviceMAMMOMATB.brilliant	Remarks
Indicationsfor Use	The MAMMOMATRevelation isintended to be	The digitalmammographysystem MAMMOMAT	Same
Attributes	Predicate deviceMAMMOMATRevelation VC20,K193166	Subject deviceMAMMOMATB.brilliant	Remarks
	used formammographyexams, screening,diagnostics,biopsies and dualenergy proceduresunder thesupervision ofmedicalprofessionals.TheMammographyimages can beinterpreted byeither hard copyfilm or soft copyworkstation.With BiopsyOption: TheInSpect feature forMAMMOMATRevelation with HDBiopsy options isintended to providedigital X-rayimages of corebiopsy specimensin order to allowrapid verificationthat the correcttissue has beenexcised with thebiopsy procedure.	B.brilliant is intendedto be used formammographyexams, screening,diagnosis, biopsies,and dual energyprocedures underthe supervision ofmedicalprofessionals.Mammographyimages can beinterpreted byeither hard copy filmor soft copyworkstation.With Biopsy Option:The InSpect featurefor MAMMOMATB.brilliant with HDBiopsy options isintended to providedigital X-ray imagesof core biopsyspecimens in order toallow rapidverification that thecorrect tissue hasbeen excised with thebiopsy procedure.
ProductCode	MUE	MUE	Same
	System configuration
X-ray Stand	Floor mounted X-ray system	Floor mounted X-raysystem	Different;housing designchanged; new Collisiondetection zone;fixed head rest andComfortGuideDisplay added tosupport patient
Attributes	Predicate deviceMAMMOMATRevelation VC20,K193166	Subject deviceMAMMOMATB.brilliant	Remarks
			positioning andtechnologist
X-rayGeneratorkV range	5 kW23 kV to 35 kV45 kV to 49 kV	5 kW23 kV to 40 kV45 kV to 49 kV	Different;Increased kV range forFFDM
X-ray Tube	P49	STTA_P49_FFS	Different;increased x-ray output
Anode-filtercombinations	W / Rh (50 µm),W/Ti (1.0 mm)	W / Al (1.0 mm)W / Ti (1.3 mm)W/Al (0.7 mm)	Different;Thickness and materialchanged.
Collimator	Automatic for allsizes	Automatic for all sizes	Different;more compact:Gain more spacebelow collimator e.g.for Biopsy
Compressionunit	Automatic andmanual operation	Automatic andmanual operation	Different;Redesign forbetter access toemergency release
Object table	Carbon fibermammographysupport system	Carbon fibermammographysupport system	Minor;Lower contouradapted;same material, samesupplier
Detector	LMAM2v2	LMAM3-DS85	Minor;new generation ofdetector; samesupplier, sametechnology;
Detectorsoftware	PEGASUS	PEGASUS	Minor;new SW Revision
Detectormanufacturer	Analogic Canada	Analogic Canada	Same
Detector TFT	Amorphous Silicon(a-Si)	Amorphous Silicon(a-Si)	Same
Detector size	24 cm x 30 cm	24 cm x 30 cm	Same
Array size	2816 x 3584	2816 x 3584	Same
Pixel size	85 µm x 85 µm	85 µm x 85 µm	Same
Grid	Reciprocating 5:1ratio	Reciprocating 5:1ratio	Same
Magnificationtable	Magnification 1.5and 1.8	Magnification 1.5 and1.8	Minor;Lower contouradapted;same material, same supplier
Attributes	Predicate deviceMAMMOMATRevelation VC20,K193166	Subject deviceMAMMOMATB.brilliant	Remarks
Biopsyattachment	Yes	Yes	Minor;Design change andLower contouradapted;same material
Tomo-guidedbiopsy	Yes	Yes	Different;lateral biopsy optionalwith tomo pre- andpostfire;
Monitor/Display	19" and 21" TFTdisplay	19" and 21" TFTdisplay	Same
Software controlled functions
Systemsoftware	VC20	VA10	Different;Improved functionality
TiCEM	Dual energyimagingW/Ti 1,0 mmHE	Dual energyimagingW/Ti 1,3 mm HE	Different;Algorithm is the same;Parameters adapteddue to x-ray spectra;increased tmeanenergy of the X-rayspectrum
AECCalculation	AEC calculation	AEC calculation	Different:Algorithm is the same.AEC parametersadjusted due to x-rayspectra.AEC pre-shot acquiredfor Tomo biopsyadapted
OperatingSystem	Windows 10	Windows 10	Same
Imageprocessingalgorithms	Opview	Opview	Different;Same algorithms;differentimplementation (nowon GPU) to accelerateprocess; state of theart on GPU as higherperformance.Parameter adjustmentsdue to new tube /x-rayspectra
DICOM	Yes	Yes	Same
Attributes	Predicate deviceΜΑΜΜΟΜATRevelation VC20,K193166	Subject deviceΜΑΜΜΟΜATB.brilliant	Remarks
Anti ScatterGrid	Yes	Yes	Same
HeadrestFace shield	Face shieldmounted ontube head	Separatestationary headrest with optionalface shield	Different;New to support patientpositioning;Face shield material isidentical.
PRIME	yes	yes	Different;Functionality same;adjustments due tonew filter;Application rangereduced.
Accessories	Compressionplate holders	Compressionholders	Different for Biopsyand magnification;Adapted as travel pathdistance forcompression unit ischanged;other holders are thesame
Accessories	Compressionplates	Compressionplates	same

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

The MAMMOMAT B.brilliant is based on the same principle of operation. It features an updated detector, a new image acquisition chain (tube, filter, collimator) and improvements to the image acquisition workflow and biopsy workflow. The image processing algorithms for FFDM are identical to those of the predicate with parameter adjustments due to the new image acquisition chain.

The subject device does introduce improvements to the present features. These improvements are:

. New software version
Improvements to the positioning of patients with ComfortMove functionality ●
Improvements to the Biopsy workflow ●
. Improvements to the Contrast Enhanced Mammography

In addition, hardware changes are made compared to MAMMOMAT Revelation

New qeneration of detector ●
New tube with flying focal spot .

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New and changed filter materials ●
New AWS-PC with state-of-the art performance ●
Improved comfort for patient due new positioning support ●
Improvements concerning usability like a ComfortGuide Display and the . adapted lighting concept.

9. Summary of Non-Clinical Tests:

The Siemens MAMMOMAT B.brilliant was tested and complies with the voluntary standards listed in the table below:

Table 2: List of Standards

DICOM standard	Digital Imaging and Communications in MedicineHealth informatics - Digital imaging and communication inmedicine (DICOM) including workflow and data management (ISO12052); English version EN ISO 12052 / NEMA PSE3
IEC 60601-1:2005 +A1:2012Edition 3.1+ ANSI/AAMI ES60601-1 /AMENDMENT1: 2012C1:2009/(R)2012 +A2:2010/(R)2012	Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance
IEC 60601-1-2:2014Edition 4.0	Medical electrical equipment – Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and tests /Endorsement notice (EN 60601-1-2 Edition 4.0 / IEC 60601-1-2:2014)
IEC 60601-1-3: 2008 +A1: 2013	Medical electrical equipment – Part 1: General requirements forsafety - 3rd collateral standard: General requirements forradiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008)
IEC 60601-1-6 Edition3.2 2020-07	Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability (IEC 60601-1-2:2013)
IEC 60601-2-28:2017Edition 3.0	Medical electrical equipment Part 2-28: Particular requirementsfor the basic safety and essential performance of Xray tubeassemblies for medical diagnosis (IEC 60601-2-28:2017)

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IEC 60601-2-45:2011+A1:2015Ed 3.1	Medical electrical equipment Part 2-45: Particular requirementsfor the basic safety and essential performance of mammographicX-ray equipment and mammographic stereotactic devices(IEC 60601-2-45:2011 + A1:2015)
ISO 10993-1:2018	Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process
ISO 14971:2019	Medical devices - Application of risk management to medicaldevices
IEC 60825-1:2014	Safety of laser products - Part 1: Equipment classification andrequirements
IEC 62304:2006 +A1:2015Edition 1.1	Medical device software - Software life cycle processes
IEC 62366-1 Edition 1.12020-06	Medical devices - Part 1: Application of usability engineering tomedical devices
ISO 17664-2:2021	Processing of health care products — Information to be providedby themedical device manufacturer for the processing of medicaldevices —Part 2: Non-critical medical devices

In addition, the following tests were conducted:

Table 3: Summary oof non-clinical Tests

Test	Objective	Test Method	Acceptance Criteria	Results
Detector characteristics	Ensure non-inferiority to predicate	As described in FDA's Class II Special Controls Guidance Document: Full-Field Digital Mammography System	Same or better than predicate	passed
Dual energy imaging	Ensure non-inferiority to predicate	Performance tests	Same or better than predicate	passed
Targeting accuracy	Ensure accuracy of the biopsy device	Accuracy tests with phantom and calibration needle.	The needle tip must be no more than +/-1 mm in x, y, z	passed

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			direction fromthe selectedtarget point.
Biopsy images	Ensure non-inferiority topredicate	Performance tests	Same or betterthan predicate	passed
PRIME	Ensure non-inferiority topredicate	Performance tests	Same or betterthan predicate	passed

The following quality assurance measures were applied to the development of the system:

Risk Analysis ●
Requirement Specification Reviews
Design Reviews ●
. Integration testing (System verification)

The data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted on the MAMMOMAT B.brilliant 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.

10. Summary of Clinical Tests:

Siemens conducted a clinical image evaluation to determine if the FFDM images, when reviewed by expert radiologists, are of acceptable quality for mammographic usage. The image evaluation was carried out according to FDA's Class II Special Controls Guidance Document: Full-Field Digital Mammography System. The image sets consisted of 19 FFDM cases including 4 cases with biopsy, 2 with PRIME, 3 with contrast enhanced mammography cases (TiCEM), 3 of those cases with magnification views.

The radiologists found all image sets to be of acceptable overall clinical image quality. The clinical image evaluation performed by 3 expert readers, together with the nonclinical testing conducted to support the change, demonstrates that the image quality of the MAMMOMAT B.brilliant with VA10 is substantially equivalent to the predicate device, the MAMMOMAT Revelation with VC20. The clinical image evaluation showed that the new MAMMOMAT B.brilliant system generates high quality images.

In summary, this clinical image evaluation, serving as supporting evidence, together with the non-clinical testing, has met the objective in demonstrating substantial equivalence when comparing the Siemens MAMMOMAT B.brilliant with VA10 to the Siemens MAMMOMAT Revelation with VC20.

11. 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.

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In addition, the MAMMOMAT B.brilliant is continuously monitored and if an error occurs the system functions will be blocked and an error message will be displayed.

Furthermore, the operators are health care professionals familiar with and responsible for the x-ray examinations to be performed. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and all equipment is subject to final performance testing.

12. Conclusion as to Substantial Equivalence:

The MAMMOMAT B.brilliant with VA10 has the same intended use, fundamental scientific technology, and performance characteristics as the predicate, MAMMOMAT Revelation with VC20 (K193166). Therefore, the MAMMOMAT B.brilliant with VA10 is substantially equivalent to the predicate MAMMOMAT Revelation with VC20.

13. Guidance documents

The following FDA guidance documents were utilized in this Premarket Notification:

Electromagnetic Compatibility (EMC) of Medical Devices ● Guidance for Industry and Food and Drug Administration Staff Document issued on June 6, 2022.
Guidance for Industry and Food and Drug Administration Staff Class II Special . Controls Guidance Document: Full-Field Digital Mammography System Document issued on March 27, 2012
Guidance for Industry and FDA Staff Guidance for the Content of Premarket . Submissions for Software Contained in Medical Devices Document issued on June 14, 2023
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: Evaluation Substantial Equivalent in Premarket . Notifications 510(k) - Guidance for Industry and Food and Drug Administration Staff Document issued on July 28, 2014
Electronic Submission Template for Medical Device 510(k) Submissions . Guidance for Industry and Food and Drug Administration Staff Document issued October 2, 2023
Cybersecurity in Medical Devices: Quality System Considerations and Content . of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff Document issued on September 27, 2023.

Regulation Number and Section

§ 892.1715 Full-field digital mammography system.

(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.