Who is the manufacturer of Mammomat Revelation?

Siemens Medi Cal Solutions, Inc. filed the 510(k) submission for Mammomat Revelation (K173408).

What is the FDA product code for Mammomat Revelation?

MUE. It is classified under 21 CFR 892.1715 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Mammomat Revelation?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Mammomat Revelation?

MAMMOMAT Inspiration Prime (K123520); AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (K122836); CONTRAST ENHANCED DIGITAL MAMMOGRAPHY (K123873).

Who can help prepare an FDA 510(k) submission like Mammomat Revelation?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Mammomat Revelation

K173408 · Siemens Medi Cal Solutions, Inc. · MUE · Mar 21, 2018 · Radiology

Device Facts

Record ID	K173408
Device Name	Mammomat Revelation
Applicant	Siemens Medi Cal Solutions, Inc.
Product Code	MUE · Radiology
Decision Date	Mar 21, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1715
Device Class	Class 2

Intended Use

The MAMMOMAT Revelation is intended to be used for mammography exams, screening, diagnostics, 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 Revelation 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; used in clinical settings by medical professionals. Inputs: X-ray radiation; outputs: digital mammographic images. Features include tomosynthesis-guided biopsy and contrast-enhanced digital mammography (CEDEM). Biopsy option includes InSpect feature for rapid verification of excised tissue via digital X-ray. System comprises examination stand, X-ray generator, gantry, tube housing, support table with detector, and acquisition workstation. Operates via automated or manual compression; provides stereotactic biopsy guidance with +/- 1 mm accuracy. Healthcare providers use images for lesion localization and diagnostic verification. Benefits include improved diagnostic capability through dual-energy imaging and biopsy verification.

Clinical Evidence

Bench testing only. Performance verified via detector characterization, dual-energy imaging quality assessment, and targeting accuracy tests (phantom/calibration needle). Targeting accuracy confirmed within +/- 1 mm of target. Compliance with IEC/ISO standards (e.g., IEC 60601-1, IEC 60601-2-45) demonstrated.

Technological Characteristics

Floor-mounted X-ray system; 5 kW generator (23-49 kV). Detector: Anrad LMAM2v2, a-Si TFT, 24x30 cm, 85 μm pixel size. Connectivity: DICOM. Software: Windows 10. Features: Reciprocating 5:1 grid, automated/manual compression, stereotactic biopsy attachment. 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, diagnostics, 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 Inspiration Prime (K123520)
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (K122836)
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY (K123873)

Related Devices

K233539 — MAMMOMAT B.brilliant · Siemens Medical Solutions USA, Inc. · Mar 27, 2024
K193166 — MAMMOMAT Revelation · Siemens Medical Solutions USA, Inc. · Jun 12, 2020
K163252 — Mammomat Fusion with Stereotactic Biopsy · Siemens Medical Solutions USA, Inc. · Jan 10, 2017
K122286 — MAMMOMAL INSPIRATION · Siemens Medical Solutions USA, Inc. · Feb 22, 2013
K151645 — MAMMOMAT Fusion · Siemens Medical Solutions USA, Inc. · Sep 14, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Siemens Medical Solutions USA, Inc. % Ms. Denise Adams Regulatory Affairs Specialist 40 Liberty Boulevard, 65-1A MALVERN PA 19355 Re: K173408 Trade/Device Name: MAMMOMAT Revelation Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: February 19, 2018 Received: February 20, 2018 Dear Ms. Adams: We have reviewed vour 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. March 21, 2018 {1}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K173408 Device Name MAMMOMAT Revelation #### Indications for Use (Describe) The MAMMOMAT Revelation is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals. The Mammography images can be inter hard copy film or soft copy workstation. With Biopsy Option: The InSpect feature for MAMMOMAT Revelation 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) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### K173408 510(k) Summary: MAMMOMAT Revelation Company: Siemens Medical Solutions, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: February 16, 2018 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 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 Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 adams.denise@siemens-healthineers.com #### Alternate Contact Person Patricia Jones Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 patricia.d.jones@siemens-healthineers.com #### 3. Device Name and Classification: | Trade Name: | MAMMOMAT Revelation | |-----------------------|------------------------------------------------| | Classification Name: | Full Field Digital, System, X-Ray Mammographic | | Classification Panel: | Radiology | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word. | Classification Regulation: | 21 CFR §892.1715 | |----------------------------|------------------| | Device Class: | 2 | | Product Code: | MUE | #### 4. Legally Marketed Predicate Devices | Primary predicate: | | |----------------------------|------------------------------------------------| | Trade Name: | MAMMOMAT Inspiration Prime | | 510(k) #: | K123520 | | Classification Name: | Full Field Digital, System, X-Ray Mammographic | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1715 | | Device Class: | Class II | | Product Code: | MUE | Secondary predicates: | Trade Name: | AFFIRM BREAST BIOPSY GUIDANCE SYSTEM | |----------------------------|--------------------------------------| | 510(k) #: | K122836 | | Classification Name: | System, X-ray, Mammographic | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1710 | | Device Class: | Class II | | Product Code: | IZH | | Trade Name: | CONTRAST ENHANCED DIGITAL MAMMOGRAPHY | |----------------------------|------------------------------------------------| | 510(k) #: | K123873 | | Classification Name: | Full Field Digital, System, X-Ray Mammographic | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1715 | | Device Class: | Class II | | Product Code: | MUE | Recalls: There are no recalls for these predicate devices. #### 5. Device Description: MAMMOMAT Revelation 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 Revelation comes with a variety of compression plates and a biopsy attachment for diagnostic adjunct procedures. {5}------------------------------------------------ # SIEMENS The MAMMOMAT Revelation features an updated detector (LMAM 2v2), an upgrade to the MS Windows 10 operating system, the capability to do contrast enhanced mammography and tomosynthesis guided biopsy. ### 6. Indication for Use: The MAMMOMAT Revelation is intended to be used for mammography exams, screening, diagnostics, 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 Revelation 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 Revelation is substantially equivalent to the commercially available Siemens MAMMOMAT Inspiration PRIME (primary predicate) (K123520), the Hologic Contrast Enhanced Digital Mammography (secondary predicate) (K123873) and the Hologic Affirm Breast Biopsy Guidance System (secondary predicate) (K122836). | Attributes | Subject device MAMMOMAT Revelation | Primary Predicate MAMMOMAT Inspiration PRIME K123520 | Remarks | |-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | Intended use | The MAMMOMAT Revelation is intended to be used for mammography exams, screening, diagnostics, 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. | The MAMMOMAT Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation. | Same but biopsy term more general and dual energy added | | Product Code | MUE | MUE | Same | | System configuration | | | | | X-ray Stand | Floor mounted X-ray system | Floor mounted X-ray system | Same | | X-ray Generator kV range | 5 kW 23kV to 49kV | 5 kW 23kV to 35kV | kV range increased for CEDEM | | X-ray Tube | Same tube but shielding of THA improved for higher kV | Same tube | No Mo focus | | Attributes | Subject device MAMMOMAT Revelation | Primary Predicate MAMMOMAT Inspiration PRIME K123520 | Remarks | | | and the Molybdenum focus is not being used anymore | | anymore | | Beam Limiting Device | 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 | LMAM2v2 | LMAM2 | Improved readout electronics | | Detector manufacturer | Anrad | Anrad | 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 3585 | 2816 x 3585 | Same | | Pixel size | 85 μm x 85 μm | 85 μm x 85 μm | Same | | Grid | Reciprocating 5:1 ratio | Reciprocating 5:1 ratio | Same | | PRIME | Same as in K123520 | Cleared with K123520 | Same | | Magnification table | Magnification 1.5 and 1.8 | Magnification 1.5 and 1.8 | Same | | Biopsy attachment | Yes | Yes | Improved | | Monitor/ Display | 19" and 21" TFT display | 19" and 21" TFT display | Same | | Software controlled functions | | | | | AEC | AEC calculation is done in the | AEC calculation is done in the | Same | | Calculation | acquisition workstation | acquisition workstation | | | Operating | Windows 10 | Windows XP | upgraded | | System | | | | | Image | Opview | Opview | Same | | processing algorithms | | | | | DICOM | Yes | Yes | Same | | Attributes | Subject device MAMMOMAT Revelation | Secondary predicate Hologic, Affirm Breast Biopsy Guidance System, K122836 | Remarks | | Biopsy Intended use | The MAMMOMAT Revelation is intended to be used for mammography exams, screening, diagnostics, 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 Revelation 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 Affirm Breast Biopsy Guidance System is an optional accessory for the Selenia Dimensions Mammography System. It is designed to allow the accurate localization of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices). | Both include biopsy With specimen imaging added to subject device | | Product Code | MUE | IZH | Both contain accessories for mammography | | Hardware | Biopsy unit slides onto object table | Biopsy unit slides onto object table | Same | | Patient positioning | Stereotactic biopsy can be performed on seated and recumbent patients | Stereotactic biopsy can be performed on seated and recumbent patients | Same | | Accuracy | +/-1 mm in X, Y and Z axis | +/-1 mm in X, Y and Z axis | Same | | Biopsy volume (vertical needle guidance) | 50 mm x 40 mm x 110 mm (2" x 1.6" x 4.3") | 50 mm x 40 mm x 110 mm (2" x 1.6" x 4.3") | Same | | Biopsy | 50 mm x 40 mm x 60 mm (2" | 50 mm x 40 mm x 60 mm (2" x | Same | | Attributes | Subject device MAMMOMAT Revelation | Secondary predicate Hologic, Affirm Breast Biopsy Guidance System, K122836 | Remarks | | volume (lateral needle guidance) | x 1.6" x 2.4") | 1.6" x 2.4") | | | Tube swivel range in stereo mode | $- 15^\circ$ and $+ 15^\circ$ | $- 15^\circ$ and $+ 15^\circ$ | Same | | Biopsy compression plate with window | 96 mm x 100 mm (3.8" x 3.9") (window size 52 mm x 42 mm (2" x 1.7"), vertical needle guidance | 96 mm x 100 mm (3.8" x 3.9") (window size 52 mm x 42 mm (2" x 1.7"), vertical needle guidance | Same | | Biopsy compression plate without window | 96 mm x 100 mm (3.8" x 3.9") (lateral needle guidance) | 96 mm x 100 mm (3.8" x 3.9") (lateral needle guidance) | Same | | Software controlled functions for stereotactic biopsy | | | | | Workflow | Automated workflow | Automated workflow | Same | #### Table 1: Comparison of the Subject to the Primary Predicate {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word. {7}------------------------------------------------ # SIEMENS #### Table 2: Comparison of the Subject to the Secondary Predicate for tomosynthesis guided biopsy {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. A black line is underneath the word. | Table 3: Comparison of the Subject to the Secondary Predicate for Contrast Enhanced | | |--------------------------------------------------------------------------------------|--| | Dual Energy Mammography (CEDEM): | | | Attributes | Subject device MAMMOMAT Revelation with CEDEM option | Secondary predicate Hologic, Contrast Enhanced Digital Mammography K123873 | Remarks | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | Intended use | The MAMMOMAT Revelation is intended to be used for mammography exams, screening, diagnostics, 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. | Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimension system. The CEDM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. | Both include dual energy | | Product Code | MUE | MUE | Same | | High energy image | | | | | kV range | 45kV to 49kV | 45kV to 49kV | Same | | Processing | Weighted subtraction | Weighted subtraction | Same | {9}------------------------------------------------ #### 8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Devices: The MAMMOMAT Revelation is based on the same mechanical stand as the primary device. Xray generation and control are the same. The Collimator, Compression unit and AEC technology are the same. The image processing algorithms are identical to those of the primary predicate. The novel features Contrast Enhanced Mammography and tomosynthesis guided biopsy are similar to the technology used with the secondary predicates from Hologic. #### 9. Summary of Non-Clinical Tests: The Siemens MAMMOMAT Revelation was tested and complies with the voluntary standards listed in the table below: #### Table 4: Conformance to Standards Reference Number, Date and Title of Standard IEC 60601-1: 2012, Ed 3.1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance IEC 60601-1-2: Ed 4, 2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests IEC 60601-1-3 Ed 2.1, 2012 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment IEC 60601-2-28 Ed 2.0. 2010. Medical electrical equipment - Part 2: Particular reguirements for the safety and essential performance of X-ray source assemblies and X-ray tube assemblies for medical diagnosis IEC 60601-2-45: 2015, 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 62366: 2014, Ed 1.1 Medical devices - Application of usability engineering to medical devices ISO 14971:2007, Medical devices - application of risk management to medical devices IEC 62304: 2006. Medical device software - Software life cycle processes ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process NEMA PS 3.1 - 3.20: 2016, Digital Imaging and Communications in Medicine (DICOM) Set IEC 60336: 2005, Medical electrical equipment - X-ray tube assemblies for medical diagnosis -Characteristics of focal spots {10}------------------------------------------------ ## SIEMI Table 5: Summary of Bench Tests | Test | Objective | Test Method | Acceptance Criteria | Results | |-----------------------------|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------| | Detector characteristics | Ensure non- inferiority to predicate | As described by FFDM special control guidance | Same or better than predicate | passed | | Dual energy imaging | Ensure diagnostic image quality | As described in System Test Record Dual Energy - Appendix E | As described in System Test Record Dual Energy | passed | | Targeting accuracy | Ensure accuracy of the biopsy device | Accuracy tests with phantom and calibration needle System Test Record Dual Energy appendix E | The needle tip must be no more than +/-1 mm in x, y, z direction from the selected target point. | Within 1 mm of target | In addition, the following bench tests were also conducted: The following quality assurance measures were applied to the development of the system: - Risk Analysis ● - Requirement Specification Reviews - Design Reviews ● - Integration testing (System verification) #### 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 MAMMOMAT Revelation continually is 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 Xray examinations to be performed. To minimize electrical and radiation hazards, Siemens adheres to recognized and established industry practice and all equipment is subject to final performance testing. #### 11. Conclusion as to Substantial Equivalence: The MAMMOMAT Revelation has the same intended use, fundamental scientific technology and performance characteristics as the predicate devices. Therefore the MAMMOMAT Revelation is substantially equivalent to the primary predicates the MAMMOMAT Inspiration PRIME and the secondary predicates from Hologic, Affirm Breast Biopsy Guidance System and Contrast Enhanced Digital Mammography.