(55 days)
No
The document describes a standard radiographic system with hardware and software modifications, but there is no mention of AI or ML capabilities, image processing algorithms, or data sets for training or testing such models.
No
The device is described as a "radiographic system" and enables "radiographic exposures" for "generating diagnostic images." It is not stated to be used for treatment purposes.
Yes
The device is described as generating "diagnostic images" by converting X-rays into image signals, which are then used by healthcare professionals for diagnosis.
No
The device is a radiographic system that includes multiple hardware components (ceiling suspension, bucky wall stand, bucky table, x-ray generator, detectors, etc.) in addition to software.
Based on the provided information, the MULTIX Impact C is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "radiographic system used in hospitals, clinics, and medical practices" for generating "diagnostic images by converting X-rays into image signals." This describes an imaging device used for visualizing internal structures of the body.
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The MULTIX Impact C does not perform this function. It uses external radiation (X-rays) to create images of the body itself.
- Device Description: The description details components like an X-ray tube, detectors, and a generator, all consistent with a radiographic imaging system, not an IVD.
Therefore, the MULTIX Impact C is a medical imaging device, specifically a radiographic system, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MULTIX Impact C is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact C enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact C is not intended for mammography.
MULTIX Impact C uses digital detectors for generating diagnostic images by converting Xrays into image signals. MULTIX Impact C is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Product codes
KPR, MQB
Device Description
The MULTIX Impact C Radiography X-ray system is a modular system of x-ray components (ceiling suspension with x-ray tube, bucky wall stand, bucky table, x-ray generator, and portable wireless and fixed detectors) based on the predicate device, the MULTIX Impact (K193089). The detectors for the subject device, MULTIX Impact C, are the same as the detectors of the predicate device. The following modifications have been made to the predicate device:
- New ceiling suspension with motorized tube tilting support for ortho function and new ceiling suspension with manual tube tilting
- Modified automatic collimator
- New Bucky Wall Stand
- Upgraded software version from VA11 to VA20 to support hardware modifications
- Modified patient table
- Modified touch user interface (TUI)
- Modified wireless remote-control console (WRCC) with new control design
The new system will be branded as the MULTIX Impact C.
Mentions image processing
MULTIX Impact C uses digital detectors for generating diagnostic images by converting Xrays into image signals.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-rays
Anatomical Site
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
Non-clinical tests (integration and functional) were conducted on the MULTIX Impact C during product development. 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.
All components of the x-ray system MULTIX Impact C were tested and found adequate. All test results are a pass and support our claim of device safety and effectiveness.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted for the MULTIX Impact C during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.
All components of the x-ray system MULTIX Impact C were tested and found adequate. All test results are a pass and support our claim of device safety and effectiveness.
Non-clinical tests (integration and functional) were conducted on the MULTIX Impact C during product development. The performance data demonstrates continued conformance with special controls for medical devices containing software.
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.
The non-clinical test data demonstrate that the MULTIX Impact C device performance is comparable to the predicate device that is currently marketed for the same intended use.
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.
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.
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
§ 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.
0
January 6, 2021
Image /page/0/Picture/1 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Siemens Medical Solutions USA, Inc. % Mr. Martin Rajchel Senior Regulatory Affairs Specialist 40 Liberty Blvd. Mail code: 65-1A MALVERN PA 19355
Re: K203340
Trade/Device Name: MULTIX Impact C Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: November 11, 2020 Received: November 12, 2020
Dear Mr. Rajchel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203340
Device Name MULTIX Impact C
Indications for Use (Describe)
MULTIX Impact C is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact C enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, or in the prone position. MULTIX Impact C is not intended for mammography.
MULTIX Impact C uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact C is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
| 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)
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3
510(k) Summary: MULTIX Impact C
K203340
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
Date Prepared: November 11, 2020
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, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
Location of Manufacturing Sites
Siemens Shanghai Medical Equipment Ltd. 278 Zhou Zhu Road Shanghai, 201318, China Establishment Registration Number: 3003202425
Siemens Healthcare GmbH Siemensstrasse 1 Forchheim, Germany 91301 Establishment Registration Number: 3004977335
2. Contact Person
Martin Rajchel Sr. Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 martin.rajchel(@siemens-healthineers.com
4
3. Subject Device Name and Classification
| Trade Name: | MULTIX Impact C |
|---|---|
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
| Secondary Product Code: | MQB |
4. Legally Marketed Predicate Device
| Trade Name: | MULTIX Impact |
|---|---|
| 510(k) #: | K193089 |
| Clearance Date: | March 20, 2020 |
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
| Reference Devices: | |
| Trade Name: | YSIO X.Pree |
| 510(k) #: | K201670 |
| Clearance Date: | October 21, 2020 |
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
| Trade Name: | Multix Fusion Max |
| 510(k) #: | K191418 |
| Clearance Date: | June 19, 2019 |
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
5
5. Device Description
The MULTIX Impact C Radiography X-ray system is a modular system of x-ray components (ceiling suspension with x-ray tube, bucky wall stand, bucky table, x-ray generator, and portable wireless and fixed detectors) based on the predicate device, the MULTIX Impact (K193089). The detectors for the subject device, MULTIX Impact C, are the same as the detectors of the predicate device. The following modifications have been made to the predicate device:
-
- New ceiling suspension with motorized tube tilting support for ortho function and new ceiling suspension with manual tube tilting
- Modified automatic collimator 2.
-
- New Bucky Wall Stand
- Upgraded software version from VA11 to VA20 to support hardware modifications 4.
- Modified patient table న్.
- Modified touch user interface (TUI) 6.
- Modified wireless remote-control console (WRCC) with new control design 7.
The new system will be branded as the MULTIX Impact C.
6. Indications for Use
MULTIX Impact C is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact C enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX
Impact C is not intended for mammography.
MULTIX Impact C uses digital detectors for generating diagnostic images by converting Xrays into image signals. MULTIX Impact C is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
7. Substantial Equivalence
MULTIX Impact C is a modification of the predicate device, the MULTIX Impact (K193089). The subject device is within the same classification regulation, has the same indications for use, and the same mechanical design as the predicate device. The MULTIX Impact C is substantially equivalent to the predicate device and documentation is provided to support a claim of substantial equivalence.
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device
MULTIX Impact C is substantially equivalent to the commercially available predicate device, MULTIX Impact (K193089) in terms of the indications for use, design, material, functionality, technology, and energy source. The subject device uses the same or similar components cleared in the MULTIX Impact (e.g. tube, generator, collimator, patient table, detectors and imaging system).
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The components of the subject device have many of the same technological characteristics as those in the predicate device. Some technological characteristics that differ slightly are shown in the comparison tables below. Verification and validation testing have been successfully completed and test results show that the subject device, MULTIX Impact C with all its components, is substantially equivalent to the predicate device.
The modifications made to the subject device, MULTIX Impact C, do not affect the intended use of the device nor do they alter its fundamental scientific technology compared to the predicate device, the MULTIX Impact (K193089).
7
The following tables compare the main performance data of the subject device with the predicate device.
| Attribute | MULTIX Impact C
(Subject) | MULTIX Impact
K193089
(Predicate) | Comparison
Results |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | MULTIX Impact C is a
radiographic system used in
hospitals, clinics, and medical
practices. MULTIX Impact C
enables radiographic exposures
of the whole body including:
skull, chest, abdomen, and
extremities and may be used on
pediatric, adult and bariatric
patients. Exposures may be
taken with the patient sitting,
standing, or in the prone
position. MULTIX Impact C is
not intended for
mammography.
MULTIX Impact C uses digital
detectors for generating
diagnostic images by
converting X- rays into image
signals.
MULTIX Impact C is also
designed to be used with
conventional film/screen or
Computed Radiography (CR)
cassettes. | The MULTIX Impact system
is a radiographic system used
in hospitals, clinics, and
medical practices. MULTIX
Impact enables radiographic
exposures of the whole body
including: skull, chest,
abdomen, and extremities and
may be used on pediatric,
adult and bariatric patients.
Exposures may be taken with
the patient sitting, standing, or
in the prone position. The
MULTIX Impact system is not
meant for mammography.
The MULTIX Impact uses
digital detectors for generating
diagnostic images by
converting X-rays into image
signals.
The MULTIX Impact is also
designed to be used with
conventional film/screen or
Computed Radiography (CR)
cassettes. | Same
(Minor
grammatical
changes only) |
| Attribute | MULTIX Impact C
(Subject) | MULTIX Impact
K193089
(Predicate) | Comparison
Results |
| Tube Stand
(TS) | Ceiling mounted manual TS
- Manual tube tilting
- Motorized tube lifting
Ceiling mounted motorized TS - Motorized tube tilting
- Motorized tube lifting | Floor mounted semi motorized
TS - Manual tube tilting
- Manual longitudinal
movement - Motorized tube lifting | Improved to support
more operational
possibilities. |
| | Hardware: Ortho Support
Software: three options as below | N.A. | |
| Ortho
function
(option) | Smart Ortho
Smart Virtual Ortho
Auto Full-Spine & Long-
Leg Collimation | N.A. | New option to support
more operational
possibilities. |
| Collimator | Automatic collimator | Automatic collimator | Same |
| | N.A. | Manual collimator | New option |
| | Modified automatic collimator | N.A. | |
| Bucky Wall
Stand
(BWS) | New BWS with motorized height
adjustment
- 5 field AEC
- Option for detector unit with
motorized lifting scope of
315mm~1750mm - Detector unit with manual
tilting | BWS with manual or
motorized height adjustment - 3 field AEC
- Option for detector unit with
manual or motorized lifting
scope of 330mm~1800mm | Improved to support
more operational
possibilities. |
| Imaging
System | Detectors - Trixell MAX wi-D= Pixium
3543EZh - iRay Core XL=Mars1717VS
- iRay Core
Static=Venu1717X | Detectors - Trixell MAX wi-D= Pixium
3543EZh - iRay Core XL=Mars1717VS
- iRay Core
Static=Venu1717X | Same |
| | Software version: VA20 | Software version: VA11 | New software version
with features like Ortho
function,
SmartPositioning, and
modifications to support
|
| Attribute | MULTIX Impact C
(Subject) | MULTIX Impact
K193089
(Predicate) | Comparison
Results |
| | User interface: - Operation Tabs are on the
top area | User interface: - Operation Tabs are on the
right sidebar | Improved appearance of
user interface. |
| Other minor modifications | | | |
| Patient table | Elevating patient table with - 5 field AEC
- Tray for wireless or fixed
detector | Fixed or elevating patient table
with - 3 field AEC
- Tray for wireless detector | Improved to support
more operational
possibilities. |
| Touch User
Interface
(TUI) | Touch user interface - physical button with
software indicator - Modified user interface for
Ortho function | Touch user interface - physical button with
silkscreen | Improved to support
more operational
possibilities. |
| Wireless
Remote
Control
Console
(WRCC) | Wireless Remote-Control
Console (WRCC) - Collimation control
- BWS lifting control
- Enabled tracking
- Tube stand motion (lifting)
control - SmartPositioning button
- Light localizer button | Wireless Remote-Control
Console (WRCC) - Collimation control
- BWS lifting control
- Enabled tracking
- Light localizer button | Improved to support
more operational
possibilities. |
Table 1: Indications for Use Comparison:
8
Table 2: Subject Device Compared to Predicate
9
10
| Product
Function | | MULTIX Impact C
(Subject) | YSIO X.pree
(K201670)
(reference) | Comparison
Results |
|-------------------------------------------|----------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Hardware | | Ortho Support(Ortho
Stand) | Ortho Support(Ortho
Stand) | Same |
| Software
(optional
license
keys) | Smart Ortho | Tilting Ortho: Ortho range
set by adjusting collimator
and tube tilt manually | Tilting Ortho: Ortho range
set by adjusting collimator
and tube tilt manually | |
| | Smart Virtual
Ortho | Ortho range set by 2D
camera in the image
system manually | Ortho range set by 3D
camera in the image
system manually | New option to
support more
operational
possibilities. |
| | Auto Full-Spine
& Long-Leg
Collimation | Otho range automatically
planned for Full-Spine &
Long-Leg by 2D camera
with manual adjustment | Otho range automatically
planned for Thorax by 3D
camera with manual
adjustment | |
Table 3: Comparison of the Ortho function to the reference device
Table 4: Comparison of the Tube Stand to the reference device
| Attribute | MULTIX Impact C
(Subject) | Multix Fusion Max
K191418
(reference) | Comparison
Results |
|--------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Tube Stand
(TS) | Ceiling mounted manual TS
- Manual tube tilting
- Motorized tube lifting | Ceiling mounted semi-motorized TS
- Manual tube tilting
- Motorized tube lifting | New option to
support more
operational
possibilities. |
| | Ceiling mounted motorized TS - Motorized tube tilting
- Motorized tube lifting | | |
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9. Nonclinical Performance Testing
Non-clinical tests were conducted for the MULTIX Impact C during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.
MULTIX Impact C conforms to the following standards: ES60601-1:2005/(R)2012 and A1:2012: IEC 60601-1-3:2008+A1:2013: IEC 60601-1-2:2014: IEC 62366-1:2015: ISO 14971:2007; IEC 60601-1-6:2013; IEC 62304:2015; IEC 60601-2-28:2017; IEC 60601-2-54:2018; NEMA PS 3.1-3.20 (2016) and ISO 10993-1:2009.
All components of the x-ray system MULTIX Impact C were tested and found adequate. All test results are a pass and support our claim of device safety and effectiveness.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005, is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted on the MULTIX Impact C 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.
General Safety and Effectiveness Concerns 10.
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 MULTIX Impact C Radiography X-ray system is continually monitored and if an error occurs the system functions will be blocked and an error message will be displayed.
Risk management is ensured via a hazard analysis which is used to identify potential hazards. These potential hazards are controlled via software development, verification, and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing. Furthermore, the operators are healthcare professionals familiar with and responsible for the x-ray examinations to be performed.
11. Conclusion as to Substantial Equivalence
The MULTIX Impact C has the same indications for use as the predicate device, MULTIX Impact (K193089). The operating environment and mechanical design are similar.
Verification and validation testing demonstrate that the MULTIX Impact C performs as intended. The non-clinical test data demonstrate that the MULTIX Impact C device
12
performance is comparable to the predicate device that is currently marketed for the same intended use.
In summary, Siemens concludes that the MULTIX Impact C does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate device, MULTIX Impact (K193089).
12. Guidance documents
The following FDA guidance documents were utilized in the documentation of this Premarket Notification:
- 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.
- 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 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
- 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: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff Document issued on: July 28, 2014
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- Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: August 14, 2013