MAMMOMAT B.brilliant (11372950)
Device Facts
| Record ID | K253678 |
|---|---|
| Device Name | MAMMOMAT B.brilliant (11372950) |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | MUE · Radiology |
| Decision Date | Jun 18, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1715 |
| Device Class | Class 2 |
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. 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 Story
Floor-mounted full-field digital mammography system; performs screening, diagnostic, and biopsy procedures. Inputs: X-ray radiation; system captures images via amorphous silicon detector. Transforms inputs using VA11 software; includes Opview image processing and ClearCEM algorithm for dual-energy contrast-enhanced mammography (CEM). Produces digital X-ray images for soft/hard copy interpretation. Features InSpect for rapid verification of core biopsy specimens. Used in clinical settings by medical professionals. Output aids clinicians in lesion detection, characterization, and biopsy guidance; facilitates clinical decision-making regarding breast health and intervention. Benefits: improved diagnostic accuracy and biopsy verification.
Clinical Evidence
Clinical image evaluation of ClearCEM and ClearCEM biopsy scout images. Evaluated 13 cases (6 4-view-ClearCEM, 4 ClearCEM biopsy scout, 3 additional 4-view-ClearCEM) by 5 expert radiologists. Primary endpoint: clinical image quality. Results: All readers scored ClearCEM images as 'good' or better; ClearCEM scout images scored 'good' or better (with minor 'satisfactory' ratings). Additional evaluation demonstrated ClearCEM algorithm capability to downgrade BI-RADS categories when no lesion enhancement is present. Bench testing confirmed targeting accuracy within +/- 1 mm.
Technological Characteristics
Floor-mounted X-ray system; 5 kW generator (23-49 kV); W/Al or W/Ti anode-filter combinations. Detector: 24x30 cm amorphous silicon (a-Si) TFT, 85 µm pixel size. Includes reciprocating 5:1 grid, magnification table (1.5x, 1.8x), and biopsy attachment. Connectivity: DICOM. Software: VA11 (updated from VA10). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-45, ISO 14971, IEC 62304.
Indications for Use
Indicated for mammography exams, screening, diagnosis, biopsies, and dual energy procedures in patients requiring breast imaging, performed under medical professional supervision.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- MAMMOMAT B.brilliant (K233539)
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 18, 2026
Siemens Medical Solutions USA, Inc.
Denise Adams
Regulatory Affairs Professional
40 Liberty Boulevard
Malvern, Pennsylvania 19355
Re: K253678
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: May 19, 2026
Received: May 20, 2026
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K253678 - Denise Adams
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assistance/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,
Digitally signed by Michael D.
O'hara -S
Date: 2026.06.18 13:44:47 -04'00'
For
Yanna Kang, 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
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K253678
Device Name
MAMMOMAT B.brilliant
Indications for Use (Describe)
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.
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 VA11 (K253678)**
**Company:** Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355
**Date Prepared:** June 17, 2026
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, Regulatory 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
**Classification Name:** Full Field Digital, System, X-Ray Mammographic
**Classification Panel:** Radiology
**Classification Regulation:** 21 CFR § 892.1715
**Device Class:** II
**Product Code:** MUE
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#### 4. Legally Marketed Predicate Device
**Trade Name:** MAMMOMAT B.brilliant
**510(k) #:** K233539
**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.
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 VA11 features updates to the Contrast Enhanced Mammography (CEM) functionality including a new optional workflow step for a CEM biopsy scout.
#### 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.
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.
#### 7. Substantial Equivalence:
The Siemens MAMMOMAT B.brilliant with VA11 is substantially equivalent to the commercially available Siemens MAMMOMAT B.brilliant with VA10 (K233539).
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**Table 1: Comparison of the Subject to the Primary Predicate**
| Attributes | predicate device MAMMOMAT B.brilliant VA10 | Subject device MAMMOMAT B.brilliant VA11 | Remarks |
| --- | --- | --- | --- |
| **Indication 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. 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. | 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. | Same |
| **Product Code** | MUE | MUE | Same |
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| Attributes | predicate device MAMMOMAT B.brilliant VA10 | Subject device MAMMOMAT B.brilliant VA11 | Remarks |
| --- | --- | --- | --- |
| **X-ray Stand** | Floor mounted X-ray system | Floor mounted X-ray system | Same |
| **X-ray Generator kV range** | 5 kW 23 kV to 40 kV 45 kV to 49 kV | 5 kW 23 kV to 40 kV 45 kV to 49 kV | Same |
| **X-ray Tube** | STTA_P49_FFS | STTA_P49_FFS | Same |
| **Anode-filter combinations** | W / Al (1.0 mm) W / Ti (1.3 mm) W/Al (0.7 mm) | W / Al (1.0 mm) W / Ti (1.3 mm) W/Al (0.7 mm) | Same |
| **Collimator** | Automatic for all sizes | Automatic for all sizes | Same |
| **Compression unit** | Automatic and manual operation | Automatic and manual operation | Same |
| **Object table** | Carbon fiber mammography support system | Carbon fiber mammography support system | Same |
| **Detector** | LMAM3-DS85 | LMAM3-DS85 | Same |
| **Detector software** | PEGASUS | PEGASUS | Same |
| **Detector manufacturer** | 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 5:1 ratio | Reciprocating 5:1 ratio | Same |
| **Magnification table** | Magnification 1.5 and 1.8 | Magnification 1.5 and 1.8 | Same |
| **Biopsy attachment** | Yes | Yes | Same |
| **(tomo-guided /stereotactic) Biopsy** | Yes | Yes | Different; Additional optional contrast enhanced biopsy scout (ClearCEM scout) |
| **Monitor/ Display** | 19' and 21' TFT display | 19' and 21' TFT display | Same |
| **Anti Scatter Grid** | Yes | Yes | Same |
| **Headrest Face shield** | Separate stationary head rest with optional face shield | Separate stationary head rest with optional face shield | Same |
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| Attributes | predicate device MAMMOMAT B.brilliant VA10 | Subject device MAMMOMAT B.brilliant VA11 | Remarks |
| --- | --- | --- | --- |
| **System software** | VA10 | VA11 | Different; Improved functionality |
| **TiCEM /ClearCEM** | Dual energy imaging | Dual energy imaging | Different; Algorithm is adapted |
| **AEC Calculation** | AEC calculation | AEC calculation | Same |
| **Operating System** | Windows 10 | Windows 10 | Same |
| **Image processing algorithms** | Opview | Opview | Same |
| **DICOM** | Yes | Yes | Same |
| **PRIME** | yes | yes | Same |
| | | | |
| **Accessories** | List of compatible components in the operator manual | List of compatible components in the operator manual | Same |
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**8. Summary of Technological Characteristics of the Subject Device as compared with the Predicate Devices:**
The MAMMOMAT B.brilliant is based on the same principle of operation. The image processing algorithms for FFDM are identical to those of the predicate.
The subject device does introduce improvements. These improvements are:
- Improvements to Contrast Enhanced Mammography
- New optional workflow step for CEM biopsy scout
**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 Medicine Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management (ISO 12052); English version EN ISO 12052 / NEMA PSE3 |
| --- | --- |
| IEC 60601-1:2005 + A1:2012 Edition 3.1 + ANSI/AAMI ES 60601-1 /AMENDMENT 1: 2012 C1:2009/(R)2012 + A2:2010/(R)2012 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-2:2014 Edition 4.0 | Medical electrical equipment – Part 1-2: General requirements for basic 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 Edition 2.2 2021-01 CONSOLIDATED VERSION | Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| IEC 60601-1-6 Edition 3.2 2020-07 | Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability (IEC 60601-1-2:2013) |
| IEC 60601-2-28:2017 Edition 3.0 | Medical electrical equipment Part 2-28: Particular requirements for the basic safety and essential performance of Xray tube assemblies for medical diagnosis (IEC 60601-2-28:2017) |
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| IEC 60601-2-45:2011+A1:2015 Ed 3.1 | Medical electrical equipment Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2011 + A1:2015) |
| --- | --- |
| ISO 14971:2019 | Medical devices – Application of risk management to medical devices |
| IEC 60825-1 Edition 2.0 2007-03 | Safety of laser products - Part 1: Equipment classification and requirements |
| IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION | Medical device software - Software life cycle processes |
| IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION | Medical devices - Part 1: Application of usability engineering to medical devices |
| ISO 17664-2 First edition 2021-02 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices |
In addition, the following tests were conducted:
**Table 3: Summary of non-clinical Tests**
| Test | Objective | Test Method | Acceptance Criteria | Results |
| --- | --- | --- | --- | --- |
| 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 direction from the selected target point. | Passed |
| Biopsy images | Ensure non-inferiority to predicate | Performance tests | Same or better than predicate | passed |
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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 the contrast enhanced images reviewed by expert radiologists are of acceptable quality for mammographic usage. The evaluation of six 4-view-ClearCEM cases and four ClearCEM biopsy scout cases by five expert radiologists and additional 3 4-view-ClearCEM cases have been evaluated by four expert radiologists. It was conducted to demonstrate that ClearCEM and ClearCEM biopsy scout images are of acceptable clinical image quality.
The clinical cases were acquired on the MAMMOMAT B.brilliant system using VA11 acquisition software and standard of practice care during screening and diagnostic mammography. Each ClearCEM case consisted of four image pairs (low energy image and recombined iodine image (Insight CEM)): craniocaudal (CC) and mediolateral oblique (MLO) views of each breast and represented a spectrum of fatty and dense breasts. Each ClearCEM biopsy scout case consisted of at least one scout image pair (low energy image and recombined iodine image).
For ClearCEM all five radiologists found all image sets to be of “good” or better overall clinical image quality. Except for reader 2 who score the overall image quality of all 6 cases as “good” the other 4 readers scored all cases with “very good” or “excellent”.
For ClearCEM Scout all five radiologists found all image sets to be of “good” or better overall clinical image quality except for reader 2 who scored the overall image quality for cases 3 and 4 with “satisfactory”. Cases 3 and 4 were scored with “good” by two radiologists, with “very good” by one radiologist and with “excellent” by another radiologist.
The additional image evaluation of the 3 cases demonstrates the ability of Siemens’ new ClearCEM algorithm to downgrade the BI-RADS category of lesions for certain images when no lesion enhancement is seen, but BPE might be present.
The contrast enhanced image quality of the MAMMOMAT B.brilliant with VA11 is substantially equivalent to the predicate device, the MAMMOMAT B.brilliant VA10. The clinical image evaluation showed that the MAMMOMAT B.brilliant VA11 system generates high quality images.
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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 VA11 to the MAMMOMAT B.brilliant with VA10.
# **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.
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 VA11 has the same intended use, fundamental scientific technology, and performance characteristics as the predicate, MAMMOMAT B.brilliant VA10 (K233539). Therefore, the MAMMOMAT B.brilliant with VA11 is substantially equivalent to the predicate MAMMOMAT B.brilliant with VA10.
# **13. Guidance documents**
The following FDA guidance documents were utilized in this Premarket Notification:
- • *Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff*
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 Equivalence 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 June 27, 2025.
