Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document mentions image processing algorithms but does not explicitly mention AI, ML, or related terms, nor does it describe any training or testing of such models. The focus is on software updates, cybersecurity, and standard image processing.

Therapeutic

No
The device is described as an X-ray system intended to visualize anatomical structures, which is a diagnostic function, not a therapeutic one. It enables radiographic and tomographic exposures, which are used to create images for diagnosis, not to treat conditions.

Diagnostic

No.
The device is an imaging system (X-ray) used to visualize anatomical structures, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as an X-ray generator, X-ray tube, collimator, ceiling rail system, and Solid State X-ray Imagers (SSXIs). While software is a key part of the system and is being updated, the device is clearly a hardware-based X-ray system.

IVD (In Vitro Diagnostic)

Based on the provided information, the Ysio Max device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for visualizing anatomical structures by converting an X-ray pattern into a visible image. This is a function of medical imaging, not in vitro diagnostics.
Device Description: The description details an X-ray system with components like an X-ray generator, tube, collimator, and imagers. These are all components of an imaging system, not a device used to examine specimens from the human body outside of the body.
No mention of biological samples: The entire description focuses on imaging the human body directly using X-rays. There is no mention of analyzing blood, urine, tissue, or any other biological sample.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Ysio Max does not perform this function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Ysio Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Ysio Max enables radiographic and tomographic exposures of the whole body and may be used on pediatric, adult and bariatric patients. It can also be used for emergency applications.

Ysio Max is not for mammography examinations.

Product codes

KPR

Device Description

The Ysio Max is a stationary X-ray system for radiography. The main components are the X-ray generator, the X-ray tube with collimator supported by a ceiling rail system. The Ysio Max comes with SSXIs (Solid State X-ray Imagers) that can be mobile or fixed in the Bucky tray. An image processing and data management system (syngo FLC) completes the radiographic suite.

The purpose of this submission is the upgrade to a new software version VF10 and minor hardware changes. The modified Yisio Max will introduce the following new features:

The operating system will be MS Windows 10
New cybersecurity features
Additional pediatric programs
Implementing a "Virtual Machine" that supports hospital IT
The SSXIs have been updated
The EMC (Electromagnetic Compatibility was tested according to the IEC . 4th edition)
. The image processing algorithms (Diamond view Plus) will be used for exposures without grid.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

whole body, including: skull, chest, abdomen, and extremities

Indicated Patient Age Range

pediatric, adult and bariatric patients

Intended User / Care Setting

hospitals, clinics, and medical practices

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Description of the test set: The tests were performed on the new software VF10.
Sample Size: Not Found
Data Source: Not Found
Annotation Protocol: Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Non-clinical performance testing, verification/validation activities.
Sample Size: Not Found
AUC: Not Found
MRMC: Not Found
Standalone Performance:

Compliance with 21 CFR 1020.30-31 Federal Performance Standards for X-Ray fluoroscopic equipment.
Compliance with various IEC, ISO, and NEMA standards.
Key Results:
The subject device with the new software VF10 is safe and effective.
The device performs comparably to the predicate device.
The software VF10 correctly performs as designed and raises no new questions regarding safety or effectiveness.
The Ysio Max with VF10 software supports a determination of substantial equivalence to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K133259

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K173639

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

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June 13, 2018

Siemens Medical Solutions, Inc. % Ms. Denise Adams Regulatory Affairs Specialist 40 Liberty Boulevard 65-1A MALVERN PA 19355

Re: K181279

Trade/Device Name: Ysio Max Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: May 14, 2018 Received: May 15, 2018

Dear Ms. 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 (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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

K181279

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 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,

Hol 2. Mild

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K181279

Device Name

Ysio Max

Indications for Use (Describe)

Y sio Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Ysio Max enables radiographic and tomographic exposures of the whole body and may be used on pediatric, adult and bariatric patients. It can also be used for emergency applications.

Ysio Max is not for mammography examinations.

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) 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, tor

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 QMB number."

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Special 510(k) Summary: Ysio Max

Company:

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

Date Prepared: June 12, 2018

This 510(k) summary of safety and effectiveness information is being submitted in accordance with 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 Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65 - 1A Malvern, PA 19355 adams.denise@siemens-healthineers.com

Alternate Contact Person:

Patricia D. 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: Ysio Max

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Classification Name: Stationary x-ray System Classification Panel: Radiology Classification Regulation: 21 CFR §892.1680 Device Class: II Product Codes: KPR

4. Legally Marketed Predicate Device:

Trade Name: Ysio Max 510(k) Number: K133259 Device Classification Name: Stationary x-ray System Regulation Medical Specialty: Radiology Review Panel: Radiology Product Code: KPR Submission Type: Special 510(k) Regulation Number: 892.1680 Device Class: II

5. Device Description:

The Ysio Max is a stationary X-ray system for radiography. The main components are the X-ray generator, the X-ray tube with collimator supported by a ceiling rail system. The Ysio Max comes with SSXIs (Solid State X-ray Imagers) that can be mobile or fixed in the Bucky tray. An image processing and data management system (syngo FLC) completes the radiographic suite.

The purpose of this submission is the upgrade to a new software version VF10 and minor hardware changes. The modified Yisio Max will introduce the following new features:

The operating system will be MS Windows 10 ●
New cybersecurity features
Additional pediatric programs ●
Implementing a "Virtual Machine" that supports hospital IT ●
The SSXIs have been updated ●
The EMC (Electromagnetic Compatibility was tested according to the IEC . 4th edition)
. The image processing algorithms (Diamond view Plus) will be used for exposures without grid.

6. Indications for Use:

Y sio Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Ysio Max enables radiographic and tomographic exposures of the whole body and may be used on pediatric, adult and bariatric patients. It can also be used for emergency applications.

Ysio Max is not for mammography examinations.

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7. Substantial Equivalence:

The new system software VF10 does not alter the intended use or the fundamental scientific technology. The device remains within the same classification regulation for the same intended use as the predicate device. The new system software design was completed in accordance with Siemens Quality Management System Design Controls comparable to the processes available for the predicate device. The scope of internationally recognized standards compliance was updated to the standards recognized at the time of the design of the new software. Verification and Validation testing was the same or similar to the testing being used with the predicate device.

The new system software version VF10 controls solid state X-ray imagers (SSXI) similar to the imagers being used with the predicate device. The updated MAX wi-D and Max mini detectors have been previously cleared in K173639.

1. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
  The subject device with the new software version VF10 uses the same X-ray generator, the same X-ray tube and similar SSXIs with the same digital imaging system and similar image processing software as the predicate device. There are no changes in the patient environment or the type of user interface.

The following tables compare the main performance data of the subject device with the predicate device to substantiate equivalence.

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	Subject Device	Predicate Device
Feature	Ysio Max	Ysio Max
K133259	Comparis
on Results
Indications for Use Comparison
Indications
for Use
statement	Ysio Max is a device
intended to visualize
anatomical structures
by converting an X-
ray pattern into a
visible image. Ysio
Max enables
radiographic and
tomographic
exposures of the
whole body and may
be used on pediatric,
adult and bariatric
patients. It can also be
used for emergency
applications.
Ysio Max is not
for
mammography
examinations.	The Ysio Max is a radio-
graphic system used in
hospitals, clinics, and
medical practices. Ysio
Max enables radiographic
and tomographic expo-
sures of the whole body
including: skull, chest,
abdomen, and extremities
and may be used on
pediatric, adult and
bariatric patients. It can
also be used for intrave-
nous, small interventions
(like biopsy, punctures,
etc.) and emergency
(trauma, critical ill)
applications.
Exposures may be taken
with the patient sitting,
standing, or in the prone
position.
The Ysio Max system is
not meant for
mammography.
The Ysio Max uses
integrated or portable
digital detectors for
generating diagnostic
images by converting x-
rays into electronic
signals. Ysio Max is also
designed to be used with
conventional film/screen
or Computed Radiography	Intended
use is the
same.
Indications
for use
have been
reworded
to
simplify.

Table 1: Comparison of the Subject Device Ysio Max to the Predicate

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Technical Comparison
X-ray
Generator	Polydoros
65/80 kW	Polydoros
65/80 kW
X-ray tube	OPTITOP
150/40/80/HC-100	OPTITOP
150/40/80/HC-100	Same
Collimator	Digital Multileaf
Collimator N	Digital Multileaf
Collimator N
Air kerma	Kerma X	Kerma X
X-ray techniques	Radiography	Radiography
Organ programs	X-ray parameters
Imaging processing
parameters	X-ray parameters
Imaging processing
parameters
Testing
IEC Compliance	IEC 4th edition for
EMC testing	IEC 3rd edition for
EMC testing	Testing according to
current IEC test scope
Digital Imaging
SSXI for Rad
imaging	Trixell Pixium
MAX wi-D =
3543EZh
MAX mini = 2430EZ
MAX Static =
4343RC	Trixell Pixium
MAX wi-D =
3543EZh
MAX mini = 2430EZ
MAX Static =
4343RC	Image Chain
is similar to predicate
device
Detector Performance
data according To
SSXI guidance are
provided
Digital imaging
system	Fluorospot Compact
aka syngo FLC	Fluorospot Compact
Image processing	Diamond View Plus	Diamond View Plus	Same processing
made user friendly
MS Operating
system	Windows 10	Windows 7	New Operating
system
Cybersecurity	Security package
based on MS Win 10	Security package
based on MS Win 7	Improved
Integration of
hospital IT	Hospital/Radiology
Information System	Hospital/Radiology
Information System	Improved
Pediatric package	Increased number of
organ programs	Organ programs	Increased number and
variability

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Table 2: Comparison of Trixell Pixium 4343RCE to the predicate Pixium 4343RC
(MAX static)

| Technical
Specifications | Trixell Pixium
4343RCE detector
(MAX static) (fixed)
(subject) | Trixell Pixium
4343RC detector
(fixed) (predicate) | Comparison
Results |
|-----------------------------|-------------------------------------------------------------------------|----------------------------------------------------------|-------------------------------|
| Dimensions | 423.3mm x 425.4 mm | 424.6 mm x 425.5 mm | Difference not
significant |
| Resolution | 2860 x 2874 pixels | 2869 x 2874 pixels | Difference not
significant |
| Pixel size | 148 um | 148 um | Same |
| Semiconductor
Material | Amorphous silicon,
a-Si | Amorphous silicon,
a-Si | Same |
| Scintillator | Cesium iodide (CsI) | Cesium iodide (CsI) | Same |
| Acquisition
denth | 16 bit | 16 bit | Same |
| DQE (Detective | DQE @ 0.05 lp/mm (2
uGy), 67% | DQE @ 0.05 lp/mm (2
uGy), 65% | Difference not
significant |
| nlations | MTF @ 1 lp/mm, 62% | MTF @ 1 lp/mm, 63% | Difference not
significant |

Table 3: Comparison of Trixell Pixium 3543 EZh to the predicate Pixium 3543EZh
(MAX wi-D)

| Technical
Specifications | Trixell Pixium 3543
EZh detector
(wireless)(subject) | Trixell Pixium 3543
EZh detector (MAX
wi-D) (wireless)
(predicate) | Comparison
Results |
|----------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------|-------------------------------|
| Dimensions | 348 mm x 424 mm | 349 mm x 425 mm | Difference not
significant |
| Resolution | 2350 x 2866 pixels | 2356 x 2872 pixels | Difference not
significant |
| Pixel size | 148 µm | 148 µm | Same |
| Semiconductor
Material | Amorphous silicon,
a-Si | Amorphous silicon,
a-Si | Same |
| Scintillator | Cesium iodide (CsI) | Cesium iodide (CsI) | Same |
| Acquisition depth | 16 bit | 16 bit | Same |
| DQE (Detective
Quantum
Efficiency) | DQE @ 1 lp/mm (2
µGy), 51% | DQE @ 1 lp/mm (2
µGy), 50% | Difference not
significant |
| MTF
(Modulations
transfer
function) | MTF @
1 lp/mm,63% | MTF @
1 lp/mm,61% | Difference not
significant |

Siemens Medical Solutions USA, Ino.

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Table 4: Comparison of Trixell Pixium 2430 EZ to the predicate Pixium 2430 EZ
(MAX mini)

| Technical
Specifications | Trixell Pixium
2430
EZ detector
(wireless)
(subject) | Trixell
Pixium 2430
EZ detector
(MAX mini)
(wireless)
(predicate) | Comparison
Results |
|----------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------|
| Dimensions | 225 mm x 284
mm | 228 mm x 284
mm | Difference not
significant |
| Resolution | 1520 x 1920
pixels | 1560 x 1920
pixels | Difference not
significant |
| Pixel size | 148 µm | 148 µm | Same |
| Semiconductor
Material | Amorphous
silicon, a-Si | Amorphous
silicon, a-Si | Same |
| Scintillator | Cesium iodide
(CsI) | Cesium iodide
(CsI) | Same |
| Acquisition
depth | 16 bit | 16 bit | Same |
| DQE
(Detective
Quantum
Efficiency) | DQE @ 1
lp/mm (2 µGy),
50% | DQE @ 1
lp/mm (2 µGy),
50% | Same |
| MTF
(Modulations
transfer
function) | MTF @ 1
lp/mm,61% | MTF @ 1
lp/mm,61% | Same |

Summary of Non-Clinical Test Data:

The software VF10 design was completed in accordance with Siemens Quality Management System Design Controls and verification and validation testing were successfully conducted. Non-clinical performance data are provided for the updated detectors. The new IEC 4th edition has been applied for the compliance to the IEC 60601-1-2 electromagnetic compatibility standard.

The tests were performed on the new software VF10 demonstrating that the device is safe and effective, performs comparably to the predicate device, and is substantially equivalent to the predicate device.

Documentation provided demonstrates compliance of the subject device to all FDA requirements stated in the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation tests of software requirements and software risk hazards.

Performance testing confirmed that the five devices comply with 21 CFR 1020.30-31 Federal Performance Standards for X-Ray Fluoroscopic equipment

The software VF10 controls solid state X-ray imagers (SSXI) that are similar in performance to the predicates. Performance data are provided according to the "Guidance

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for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, issued on: September 1, 2016''. X-ray geometry and techniques are the same so that clinical image comparisons involving SSXI were not conducted.

Together, the verification/validation activities successfully confirmed that the software requirements have been fulfilled and that system functionality is consistent with the user needs and intended uses. The VF10 software correctly performs as designed and raises no new questions regarding safety or effectiveness. Therefore, when compared to the predicate device the Ysio Max with the new software VF10 support a determination of substantial equivalence to the predicate device.

9. Summary of Non-Clinical Tests

The devices operating with software VF10 comply with the voluntary standards as listed in the following table:

| Development
Organization and

Reference Number	Title of Standard
IEC 60601-1:2012,
Edition 3.1	Medical Electrical Equipment - Part 1: General
Requirements for Safety
IEC 60601-1-2:2007
Edition 4.0	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: 2012,
Edition 2.1	Medical electrical equipment - Part 1-3: General
requirements for basic safety and essential
performance - Collateral Standard: Radiation
protection in diagnostic X-ray equipment
IEC 62366:2014
Edition 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 Ed. 1.0,
2006	Medical device software - Software life cycle
processes
IEC 60601-2-28:2010
Edition 2.0	Medical electrical equipment - Part 2-28: Particular
requirements for the basic safety and essential
performance of X-ray tube assemblies for medical
diagnosis
IEC 60601-2-54, 2009
Edition 1.0	Medical electrical equipment - Part 2-54: Particular
requirements for the basic safety and essential
performance of X-ray equipment for radiography
and radioscopy
IEC 61910-1, 2014	Medical electrical equipment - Radiation dose
documentation - Part 1: Radiation dose structured
reports for radiography and radioscopy (IEC 61910-
1:2014)

Table 5: Standards

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| NEMA PS 3.1 - 3.20,
2011 | Digital Imaging and Communications in Medicine
(DICOM) Set |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------|
| ISO 10993-1, 2009 | Biological evaluation of medical devices -- Part 1:
Evaluation and testing within a risk management
process |

Documentation provided demonstrates compliance of the subject devices to all FDA requirements stated in the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation tests of software requirements and software risk hazards.

Performance testing confirmed that the Ysio Max with VF10 complies with 21 CFR 1020.30-31 Federal Performance Standards for X-Ray equipment. The 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
1020.31(k)	Leakage Radiation
1020.30(m)	Beam Quality
1020.31(a)	Peak Tube Potential
1020.31 (d)(2)(i, iii)	Alignment of visually defined X-ray fields and contrast
of light defined X-ray field.
1020.31 (e)(1)(i)	Alignment of the center of the radiographic X-ray field
with the center of the image receptor
1020.31 (e)(1)(ii, iii)	Radiography X-ray field size and image receptor size

The software VF10 controls solid state X-ray imagers (SSXI) that are similar in performance to the predicates. Performance data are provided according to the "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, issued on: September 1, 2016".

10. Summary of Clinical Tests:

For the subject of this premarket submission, Siemens did not do an evaluation of the clinical image quality as X-ray technology; geometry and SSXI changes are minor.

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 devices are continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.

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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 Ysio Max with VF10 software has the same intended use as the predicate device. The operating environment is the same and the technology differences do not affect safety and effectiveness. Siemens concludes via the documentation provided in this 510(k) submission that the radiology device Ysio Max with VF10 is substantially equivalent to the predicate device Ysio Max.

13. Guidance documents

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

Guidance for Industry and FDA Staff ●
Bundling Multiple Devices or Multiple Indications in a Single Submission Document issued on: June 22, 2007
Content of Premarket Submissions for Management of Cybersecurity in . Medical Devices
Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014
Information to Support a Claim of Electromagnetic Compatibility ● (EMC) of Electrically-Powered Medical Devices
Guidance for Industry and Food and Drug Administration Staff Document issued on July 11, 2016. The draft of this document was issued on November 2, 2015.

Pediatric Information for X-ray ● Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff Document issued on November 28, 2017.

. Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices 1 Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016

● Guidance for Industry and FDA Staff

Guidance for the Content of Premarket Submissions for Software contained in Medical Devices, Document issued on: May 11, 2005

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Guidance for Industry and FDA Staff . Recognition and Use of Consensus Standards Document issued on: September 17, 2007

The 510(k) Program: Evaluating Substantial Equivalence in Premarket . Notifications [510(k)]
Guidance for Industry and Food and Drug Administration Staff Document issued on: July 28, 2014

Radio Frequency Wireless Technology in Medical Devices . Guidance for Industry and Food and Drug Administration Staff Document issued on: August 14, 2013