(48 days)
Not Found
No
The summary describes a standard radiographic system with hardware and software upgrades, but there is no mention of AI or ML capabilities, image processing algorithms, or performance studies related to AI/ML.
No.
The device is described as a radiographic system used to generate diagnostic images, not to provide therapy.
Yes
The device is described as generating "diagnostic images" by converting X-rays into image signals, indicating its role in providing information for diagnosis.
No
The device description explicitly lists multiple hardware components (X-ray Tube Assembly, Collimator, Generator, patient table, Tube-side control module, portable wireless detector) and describes it as a "modular system of x-ray components." While it mentions upgraded software, the core device is a physical radiographic system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The MULTIX Impact E is a radiographic system that uses X-rays to create images of the internal structures of the body. It does not perform tests on biological samples.
- Intended Use: The intended use describes the device as a radiographic system for generating diagnostic images of the whole body. This is consistent with imaging devices, not IVDs.
Therefore, the MULTIX Impact E falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
MULTIX Impact E is a radiographic system used in hospitals, clinics, and medical practices.
MULTIX Impact E enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and obese patients. Exposures may be taken with the patient sitting, standing, or in the prone position.
MULTIX Impact E uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact E is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
MULTIX Impact E is not intended for mammography.
Product codes (comma separated list FDA assigned to the subject device)
KPR, MQB
Device Description
The MULTIX Impact E Radiography X-ray system is a modular system of x-ray components (floor-mounted x-ray tube, bucky wall stand, bucky table, x-ray generator, portable wireless detector) based on the predicate device, the MULTIX Impact (K203345). The following modifications have been made to the predicate device:
- A new X-ray Tube Assembly 1)
- A new Collimator 2)
- A new Generator 3)
-
- Fixed patient table
- Tube-side control module (TCM) \2)
-
- Upgraded software version to VB10 to support hardware modifications
The modified system will be branded as the MULTIX Impact E.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-rays
Anatomical Site
whole body including: skull, chest, abdomen, and extremities
Indicated Patient Age Range
pediatric, adult
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted for the MULTIX Impact E during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.
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.
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.
Not Found
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
U.S. FOOD & DRUG
ADMINISTRATION
Siemens Medical Solutions USA, Inc. % Denise Adams Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355
Re: K220919
Trade/Device Name: MULTIX Impact E Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: March 28, 2022 Received: March 30, 2022
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 (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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
May 17, 2022
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT 8B: Division of Radiological Imaging and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220919
Device Name MULTIX Impact E
Indications for Use (Describe)
MULTIX Impact E is a radiographic system used in hospitals, clinics, and medical practices.
MULTIX Impact E enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and obese patients. Exposures may be taken with the patient sitting, standing, or in the prone position.
MULTIX Impact E uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact E is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. MULTIX Impact E is not intended for mammography.
| 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
Image /page/3/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern.
510(k) Summary: MULTIX Impact E
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Date Prepared: May 16, 2022
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
Manufacturer
Siemens Shanghai Medical Equipment Ltd. 278 Zhou Zhu Road Shanghai, 201318, China Establishment Registration Number: 3003202425
Contract Manufacturer
Siemens Healthcare GmbH Siemensstrasse 1 Forchheim, Germany 91301 Establishment Registration Number: 3004977335
2. Contact Person
Denise Adams Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 610-448-6545 adams.denise@siemens-healthineers.com
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3. Subject Device Name and Classification
| Trade Name: | MULTIX Impact E |
|---|---|
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
4. Legally Marketed Predicate Device
| Trade Name: | MULTIX Impact (VA20) |
|---|---|
| 510(k) #: | K203345 |
| 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 |
5. Device Description
The MULTIX Impact E Radiography X-ray system is a modular system of x-ray components (floor-mounted x-ray tube, bucky wall stand, bucky table, x-ray generator, portable wireless detector) based on the predicate device, the MULTIX Impact (K203345). The following modifications have been made to the predicate device:
- A new X-ray Tube Assembly 1)
- A new Collimator 2)
- A new Generator 3)
-
- Fixed patient table
- Tube-side control module (TCM) ર)
-
- Upgraded software version to VB10 to support hardware modifications
The modified system will be branded as the MULTIX Impact E.
6. Indications for Use
MULTIX Impact E is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact E enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and obese patients. Exposures may be taken with the patient sitting, standing, or in the prone position.
MULTIX Impact E uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact E is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
MULTIX Impact E is not intended for mammography.
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Image /page/5/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the text is a series of orange dots arranged in a circular pattern.
7. Substantial Equivalence
The MULTIX Impact E is a modification of the predicate device, the MULTIX Impact (VA20), cleared via K203345. The subject device is within the same classification regulation, has the similar indications for use, and the similar mechanical design as the predicate device. The MULTIX Impact E 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
The MULTIX Impact E is substantially equivalent to the commercially available MULTIX Impact (K203345) in terms of the intended use, design, biocompatibility material, functionality, technology, and energy source. The subject device uses the same or similar components cleared in the MULTIX Impact (e.g. detector, BWS and imaging system).
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 E with all its components, is substantially equivalent to the predicate device.
The modifications made to the subject device, MULTIX Impact E, 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 (K203345).
The following tables compare the main performance data of the subject device with the predicate device.
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| Attribute | MULTIX Impact E
VB10
(Subject) | MULTIX Impact VA20
K203345
(Predicate) | Comparison
Results |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | MULTIX Impact E is a
radiographic system used
in hospitals, clinics, and
medical practices.
MULTIX Impact E
enables radiographic
exposures of the whole
body including: skull,
chest, abdomen, and
extremities and may be
used on pediatric, adult
and obese patients.
Exposures may be taken
with the patient sitting,
standing, or in the prone
position.
MULTIX Impact E uses
digital detectors for
generating diagnostic
images by converting X-
rays into image signals.
MULTIX Impact E is
also designed to be used
with conventional
film/screen or Computed
Radiography (CR)
cassettes.
MULTIX Impact E is not
intended for
mammography. | MULTIX Impact 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. MULTIX Impact is
not intended for
mammography.
MULTIX Impact uses digital
detectors for generating
diagnostic images by
converting X- rays into image
signals. MULTIX Impact is
also designed to be used with
conventional film/screen or
Computed Radiography (CR)
cassettes. | Same |
| Attribute | MULTIX Impact E
VB10
(Subject) | MULTIX Impact VA20
K203345
(Predicate) | Comparison Results |
| Detector | Wireless detector: Mars1717VS | Wireless detector:
Mars1717VS | Same |
| Tube Stand
(TS) | Integrated fully manual TS
- Manual tube tilting
- Manual longitudinal
movement - Manual tube lifting | Independent semi-motorized TS
- Manual tube tilting
- Manual longitudinal
movement - Motorized tube lifting | Different.
New tube modified from
motorized to manual for
lower cost. Verification
and Validation testing
concluded no impact on
safety and effectiveness. |
| X-ray Tube | RAY-12 3S tube with
following key performance:
-Heat capacity of anode: 170KJ
(230kHU)
-Input Power with Ref.300W:
54KW
-Anode rotary frequency: 50/60
Hz (3000/3600 rpm) | RAY-14S 3F tube with
following key performance:
-Heat capacity of anode: 260KJ
(350kHU)
-Input Power with Ref.300W:
78KW
-Anode rotary frequency:
150/180 Hz(~ 8500 to 10800
rpm) | Different.
Performance reduced
for lower cost and low-
end market. Verification
and Validation testing
concluded no impact on
safety and effectiveness. |
| Collimator | Manual collimator with
feedback following information
to system:
-Blade positions
-Cu filter status | Manual collimator without any
feedback information to system | Different.
Function improved to
support more
operational possibilities.
Verification and
Validation testing
concluded no impact on
safety and effectiveness. |
| Generator | 50KW high frequency X-ray
Generator with line voltage 3-
phase, 380V / 400V / 440V
(50/60Hz), 480 V (60Hz) | 55KW/65KW/80KW high
frequency X-ray Generator with
line voltage 3-phase, 380V /
400V / 440V (50/60Hz), 480 V
(60Hz) | Different.
Configuration reduced
for lower cost and low-
end market.
Verification and
Validation testing
concluded no impact on
safety and effectiveness. |
| | 40KW high frequency X-ray
Generator with line voltage 1-
phase, 208-230V
/(50/60Hz) | N.A. | Different.
Modified to support
more operational
possibilities. |
| Attribute | MULTIX Impact E
VB10
(Subject) | MULTIX Impact VA20
K203345
(Predicate) | Comparison Results |
| | | | Verification and
Validation testing
concluded no impact on
safety and effectiveness. |
| Automatic
Exposure
Control
(AEC) | 3 fields AEC chamber with
analog interface to system | 5 fields AEC module with CAN
interface to system | Different.
Modified for lower cost
and low-end market.
Verification and
Validation testing
concluded no impact on
safety and effectiveness. |
| Patient Table | Fixed table with integrated rail
mounting tube stand | Fixed table without rail | Different.
Modified for lower cost
and low-end market.
Verification and
Validation testing
concluded no impact on
safety and effectiveness. |
| Human
Machine
Interface
(HMI) | Tube-side control module
(TCM) with following
functions:
-SID display
-Tube angle display
-Release brakes | N.A. | Different.
Modified to support
more operational
possibilities.
Verification and
Validation testing
concluded no impact on
safety and effectiveness. |
| | Touch User Interface module
(TUI) | Touch User Interface module
(TUI) | Same |
| | N.A. | Remote Interface supported by
Siemens provided tablet that
meets minimum requirements. | Different.
Function reduced for
lower cost and low-end
market. Verification and
Validation testing
concluded no impact on
safety and effectiveness. |
| UI (User
Interface) on
Imaging
System | Siemens UI concept | Siemens UI concept | Same |
| Attribute | MULTIX Impact E
VB10
(Subject) | MULTIX Impact VA20
K203345
(Predicate) | Comparison Results |
| Software
version | VB10 | VA20 | Different
Updated to support all
hardware modifications.
Verification and
Validation testing
concluded no impact on
safety and effectiveness. |
Table 1: Indications for Use Comparison:
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Table 2: Subject Device Compared to Predicate
Tel.: +1-888-826-9702
usa.siemens.com/healthineers
8
Image /page/8/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
40 Liberty Boulevard
Malvern, PA 19355
USA
Tel.: +1-888-826-9702
usa.siemens.com/healthineers
9
Image /page/9/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots.
9. Nonclinical Performance Testing
Non-clinical tests were conducted for the MULTIX Impact E during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.
MULTIX Impact E conforms to the following standards: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012; IEC 60601-1-3:2013; IEC 60601-1-2:2014; IEC 62366-1:2015; ISO 14971:2019; 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 10993-1:2018.
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 E 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. 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 MULTIX Impact E 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.
40 Liberty Boulevard
Malvern, PA 19355
USA
10
Image /page/10/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
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, 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 E has the similar indications for use as the predicate device, MULTIX Impact (K203345). The operating environment is same and mechanical design is similar.
Verification and validation testing demonstrate that the MULTIX Impact E performs as intended. The non-clinical test data demonstrate that the MULTIX Impact E device performance is comparable to the predicate device that is currently marketed for the same intended use.
In summary, Siemens concludes that the MULTIX Impact E does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device, MULTIX Impact (K203345).
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 Industrv 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
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- 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
- • Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: August 14, 2013