MULTIX Impact C

K203340 · Siemens Medical Solutions USA, Inc. · KPR · Jan 6, 2021 · Radiology

Device Facts

• Record ID: K203340
• Device Name: MULTIX Impact C
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: KPR · Radiology
• Decision Date: Jan 6, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Radiographic X-ray system for hospitals/clinics; operated by healthcare professionals. Inputs: X-ray radiation; outputs: diagnostic images via digital detectors, film/screen, or CR cassettes. System components: ceiling-mounted tube stand (manual/motorized), bucky wall stand, bucky table, generator, and wireless/fixed detectors. Features include motorized tube tilting, automatic collimator, and touch user interface. Ortho function options (Smart Ortho, Smart Virtual Ortho, Auto Full-Spine & Long-Leg Collimation) assist in planning and positioning. Wireless remote-control console enables motion control and positioning. System monitors performance; blocks functions and displays error messages upon failure. Benefits: enables diagnostic imaging across diverse patient populations and clinical settings.

Clinical Evidence

Bench testing only. Verification and validation testing performed to support hardware and software modifications. Conformance to standards including ES60601-1, IEC 60601-1-3, IEC 60601-1-2, IEC 62366-1, ISO 14971, IEC 62304, and ISO 10993-1. Risk analysis and integration/functional testing confirmed specifications met acceptance criteria.

Technological Characteristics

Stationary X-ray system. Components: ceiling-mounted tube stand, bucky wall stand, bucky table, X-ray generator, digital detectors. Materials conform to ISO 10993-1. Energy source: electrical. Connectivity: wireless/fixed detectors. Software: VA20 version. Standards: ES60601-1, IEC 60601-1-3, IEC 60601-1-2, IEC 62366-1, ISO 14971, IEC 62304, IEC 60601-2-28, IEC 60601-2-54, NEMA PS 3.1-3.20.

Indications for Use

Indicated for radiographic imaging of the whole body (skull, chest, abdomen, extremities) in pediatric, adult, and bariatric patients. Not for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MULTIX Impact (K193089)

Reference Devices

• YSIO X.Pree (K201670)
• Multix Fusion Max (K191418)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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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# 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

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## 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 |

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### 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:

- 1. New ceiling suspension with motorized tube tilting support for ortho function and new ceiling suspension with manual tube tilting
- Modified automatic collimator 2.
- 3. 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).

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

| Attribute | MULTIX Impact C<br>(Subject) | MULTIX Impact<br>K193089<br>(Predicate) | Comparison<br>Results |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | MULTIX Impact C is a<br>radiographic system used in<br>hospitals, clinics, and medical<br>practices. MULTIX Impact C<br>enables radiographic exposures<br>of the whole body including:<br>skull, chest, abdomen, and<br>extremities and may be used on<br>pediatric, adult and bariatric<br>patients. Exposures may be<br>taken with the patient sitting,<br>standing, or in the prone<br>position. MULTIX Impact C is<br>not intended for<br>mammography.<br>MULTIX Impact C uses digital<br>detectors for generating<br>diagnostic images by<br>converting X- rays into image<br>signals.<br>MULTIX Impact C is also<br>designed to be used with<br>conventional film/screen or<br>Computed Radiography (CR)<br>cassettes. | The MULTIX Impact system<br>is a radiographic system used<br>in hospitals, clinics, and<br>medical practices. MULTIX<br>Impact enables radiographic<br>exposures of the whole body<br>including: skull, chest,<br>abdomen, and extremities and<br>may be used on pediatric,<br>adult and bariatric patients.<br>Exposures may be taken with<br>the patient sitting, standing, or<br>in the prone position. The<br>MULTIX Impact system is not<br>meant for mammography.<br>The MULTIX Impact uses<br>digital detectors for generating<br>diagnostic images by<br>converting X-rays into image<br>signals.<br>The MULTIX Impact is also<br>designed to be used with<br>conventional film/screen or<br>Computed Radiography (CR)<br>cassettes. | Same<br>(Minor<br>grammatical<br>changes only) |
| Attribute | MULTIX Impact C<br>(Subject) | MULTIX Impact<br>K193089<br>(Predicate) | Comparison<br>Results |
| Tube Stand<br>(TS) | Ceiling mounted manual TS<br>- Manual tube tilting<br>- Motorized tube lifting<br>Ceiling mounted motorized TS<br>- Motorized tube tilting<br>- Motorized tube lifting | Floor mounted semi motorized<br>TS<br>- Manual tube tilting<br>- Manual longitudinal<br>movement<br>- Motorized tube lifting | Improved to support<br>more operational<br>possibilities. |
| | Hardware: Ortho Support<br>Software: three options as below | N.A. | |
| Ortho<br>function<br>(option) | Smart Ortho<br>-<br>Smart Virtual Ortho<br>-<br>Auto Full-Spine & Long-<br>-<br>Leg Collimation | N.A. | New option to support<br>more operational<br>possibilities. |
| Collimator | Automatic collimator | Automatic collimator | Same |
| | N.A. | Manual collimator | New option |
| | Modified automatic collimator | N.A. | |
| Bucky Wall<br>Stand<br>(BWS) | New BWS with motorized height<br>adjustment<br>- 5 field AEC<br>- Option for detector unit with<br>motorized lifting scope of<br>315mm~1750mm<br>- Detector unit with manual<br>tilting | BWS with manual or<br>motorized height adjustment<br>- 3 field AEC<br>- Option for detector unit with<br>manual or motorized lifting<br>scope of 330mm~1800mm | Improved to support<br>more operational<br>possibilities. |
| Imaging<br>System | Detectors<br>- Trixell MAX wi-D= Pixium<br>3543EZh<br>- iRay Core XL=Mars1717VS<br>- iRay Core<br>Static=Venu1717X | Detectors<br>- Trixell MAX wi-D= Pixium<br>3543EZh<br>- iRay Core XL=Mars1717VS<br>- iRay Core<br>Static=Venu1717X | Same |
| | Software version: VA20 | Software version: VA11 | New software version<br>with features like Ortho<br>function,<br>SmartPositioning, and<br>modifications to support<br> |
| Attribute | MULTIX Impact C<br>(Subject) | MULTIX Impact<br>K193089<br>(Predicate) | Comparison<br>Results |
| | User interface:<br>- Operation Tabs are on the<br>top area | User interface:<br>- Operation Tabs are on the<br>right sidebar | Improved appearance of<br>user interface. |
| Other minor modifications | | | |
| Patient table | Elevating patient table with<br>- 5 field AEC<br>- Tray for wireless or fixed<br>detector | Fixed or elevating patient table<br>with<br>- 3 field AEC<br>- Tray for wireless detector | Improved to support<br>more operational<br>possibilities. |
| Touch User<br>Interface<br>(TUI) | Touch user interface<br>- physical button with<br>software indicator<br>- Modified user interface for<br>Ortho function | Touch user interface<br>- physical button with<br>silkscreen | Improved to support<br>more operational<br>possibilities. |
| Wireless<br>Remote<br>Control<br>Console<br>(WRCC) | Wireless Remote-Control<br>Console (WRCC)<br>- Collimation control<br>- BWS lifting control<br>- Enabled tracking<br>- Tube stand motion (lifting)<br>control<br>- SmartPositioning button<br>- Light localizer button | Wireless Remote-Control<br>Console (WRCC)<br>- Collimation control<br>- BWS lifting control<br>- Enabled tracking<br>- Light localizer button | Improved to support<br>more operational<br>possibilities. |

Table 1: Indications for Use Comparison:

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# Table 2: Subject Device Compared to Predicate

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| Product<br>Function | | MULTIX Impact C<br>(Subject) | YSIO X.pree<br>(K201670)<br>(reference) | Comparison<br>Results |
|-------------------------------------------|----------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Hardware | | Ortho Support(Ortho<br>Stand) | Ortho Support(Ortho<br>Stand) | Same |
| Software<br>(optional<br>license<br>keys) | Smart Ortho | Tilting Ortho: Ortho range<br>set by adjusting collimator<br>and tube tilt manually | Tilting Ortho: Ortho range<br>set by adjusting collimator<br>and tube tilt manually | |
| | Smart Virtual<br>Ortho | Ortho range set by 2D<br>camera in the image<br>system manually | Ortho range set by 3D<br>camera in the image<br>system manually | New option to<br>support more<br>operational<br>possibilities. |
| | Auto Full-Spine<br>& Long-Leg<br>Collimation | Otho range automatically<br>planned for Full-Spine &<br>Long-Leg by 2D camera<br>with manual adjustment | Otho range automatically<br>planned for Thorax by 3D<br>camera with manual<br>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<br>(Subject) | Multix Fusion Max<br>K191418<br>(reference) | Comparison<br>Results |
|--------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Tube Stand<br>(TS) | Ceiling mounted manual TS<br>- Manual tube tilting<br>- Motorized tube lifting | Ceiling mounted semi-motorized TS<br>- Manual tube tilting<br>- Motorized tube lifting | New option to<br>support more<br>operational<br>possibilities. |
| | Ceiling mounted motorized TS<br>- Motorized tube tilting<br>- 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

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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