(200 days)
Yes
The summary explicitly mentions "AI-based Auto Cropping" and "AI based Automatic collimation" as modifications to the device.
No.
The device is described as a digital X-ray system intended for visualizing anatomical structures and generating X-ray images to support diagnostic and/or therapeutic decisions, but not for direct therapeutic treatment itself.
Yes.
The device's intended use explicitly states that the acquired images "support medical professionals to make diagnostic and/or therapeutic decisions," indicating its role in the diagnostic process.
No
The device description explicitly states it is a "radiography X-ray system" and lists multiple hardware components such as a ceiling suspension with an X-ray tube, Bucky wall stand, Bucky table, X-ray generator, and detectors. While it includes software features like image processing and AI-based functions, it is fundamentally a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "visualize anatomical structures of human beings by converting an X-ray pattern into a visible image." This describes an imaging system used for diagnostic purposes on the patient's body, not for testing samples in vitro (outside the body).
- Device Description: The device is described as a "radiography X-ray system" with components like an X-ray tube, detectors, and a generator. These are all components of an imaging system, not an IVD.
- Input Imaging Modality: The input is X-ray, which is an imaging modality used on the patient, not for analyzing samples.
- Anatomical Site: The device is used on the "whole body including the skull, chest, abdomen, and extremities," which are all parts of the human body, not samples taken from the body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device clearly operates by imaging the patient directly.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The intended use of the device YSIO X.pree is to visualize anatomical structures of human beings by converting an X-ray pattern into a visible image.
The device is a digital X-ray system to generate X-ray images from the whole body including the skull, chest, abdomen, and extremities. The acquired images support medical professionals to make diagnostic and/or therapeutic decisions.
YSIO X.pree is not for mammography examinations.
Product codes
KPR
Device Description
The YSIO X.pree is a radiography X-ray system. It is designed as a modular system with components such as a ceiling suspension with an X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless, and fixed integrated detectors that may be combined into different configurations to meet specific customer needs.
The following modifications have been made to the cleared predicate device:
- -New Camera Model in Collimator
- -New Auto Collimation Function: Auto Long-Leg/Full-Spine
- -Two new wireless detectors
Mentions image processing
Image processing with myExam IQ
Mentions AI, DNN, or ML
AI-based Auto Cropping
AI based Automatic collimation
Input Imaging Modality
X-ray
Anatomical Site
whole body including the skull, chest, abdomen, and extremities
Indicated Patient Age Range
The previous predicate device (YSIO X.pree VA10) explicitly stated: "YSIO X.pree enables radiographic exposures of the whole body and may be used on pediatric, adult and bariatric patients." The subject device (YSIO X.pree VA20) states "human beings" and does not specify age ranges.
Intended User / Care Setting
medical professionals
The document also mentions a clinical environment and Universitätsklinikum Augsburg, Germany.
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
A Customer Use Test (CUT) was performed at the "Universitätsklinikum Augsburg, Germany, to ensure the acceptance of the design and to gather feedback on the usability of the device on the clinical environment.
The focus of the test was:
- System function and performance-related clinical workflow
- Image quality
- Ease of use
- Overall performance and stability
The results of the clinical test stated that the intended use of the system was met, and the clinical need covered.
The newly introduced wireless detectors (X.wi-D35 and X.wi D43) were tested during a Clinical Use Test (CUT) at University Hospital Augsburg in Germany according to "Guidance of Submission of 510(k)s for Solid State X-ray Imaging Devices" Document issued on: September 1, 2016. All images acquired with the new detectors were sufficiently acceptable for radiographic usage. Together with the non-clinical testing, it has met the objective of demonstrating substantial equivalence when comparing the Siemens YSIO X.pree VA20 to the Siemens YSIO X.pree VA10 detectors.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A Customer Use Test (CUT) was performed at the "Universitätsklinikum Augsburg, Germany" focusing on:
- System function and performance-related clinical workflow
- Image quality
- Ease of use
- Overall performance and stability
Key results: The intended use of the system was met, and the clinical need covered. All images acquired with the new detectors were sufficiently acceptable for radiographic usage.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. % Camila Rodriguez Valentin Regulatory Affairs Professional 40 Liberty Boulevard Malvern, Pennsylvania 19355
Re: K233543
Trade/Device Name: YSIO X.pree Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: November 3, 2023 Received: April 24, 2024
Dear Camila Rodriguez Valentin:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Image /page/1/Picture/6 description: The image shows the names Gabriela M. Rodal -S and Lu Jiang, Ph.D. The names are stacked on top of each other. The text is black and the background is white.
Digitally signed by for Gabriela M. Rodal -S
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
K233543
Device Name
YSIO X.pree
Indications for Use (Describe)
The intended use of the device YSIO X.pree is to visualize anatomical structures of human beings by converting an X-ray pattern into a visible image.
The device is a digital X-ray system to generate X-ray images from the whole body including the skull, chest, abdomen, and extremities. The acquired images support medical professionals to make diagnostic and/or therapeutic decisions.
YSIO X.pree 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)
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| 510(k) Summary: | YSIO X.pree |
|---|---|
| 510(k) Number: | K233543 |
| Company: | Siemens Medical Solutions USA, Inc. |
| 40 Liberty Boulevard | |
| Malvern, PA 19355 | |
| Date Prepared: | May 20, 2024 |
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR § 807.92.
General Information: 1.
Importer / Distributor:
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869
Location of Manufacturing Site:
Siemens Healthineers AG Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335
2. Contact Person:
Camila Rodriguez Valentin Regulatory Affairs Professional Siemens Medical Solutions USA, Inc.40 Liberty Boulevard Malvern, PA 19355, US camila.rodriguezvalentin@siemens-healthineers.com
Alternate Contact Person:
Martin Rajchel Senior Regulatory Affairs Manager Siemens Medical Solutions USA, Inc.40 Liberty Boulevard Malvern, PA 19355, US martin.rajchel @ siemens-healthineers.com
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3. Subject Device Name and Classification:
Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
YSIO X.pree Stationary x-ray system Radiology 21 CFR §892.1680 II KPR
4. Legally Marketed Predicate Device:
| Trade Name: | YSIO X.pree |
|---|---|
| Company: | Siemens Healthineers AG |
| 510(k) Number: | K201670 |
| Classification Name: | Stationary x-ray system |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | II |
| Product Code: | KPR |
ട. Legally Marketed Reference Device:
| Trade Name: | MULTIX Impact (VA21) |
|---|---|
| Company: | Siemens Shanghai Medical Equipment Ltd. |
| 510(k) Number: | K213700 |
| Classification Name: | Stationary x-ray system |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1680 |
| Device Class: | II |
| Product Code: | KPR |
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6. Device Description:
The YSIO X.pree is a radiography X-ray system. It is designed as a modular system with components such as a ceiling suspension with an X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless, and fixed integrated detectors that may be combined into different configurations to meet specific customer needs.
The following modifications have been made to the cleared predicate device:
- -New Camera Model in Collimator
- -New Auto Collimation Function: Auto Long-Leg/Full-Spine
- -Two new wireless detectors
7. Indication for Use:
The intended use of the device YSIO X.pree is to visualize anatomical structures of human beings by converting an X-ray pattern into a visible image.
The device is a digital X-ray system to generate X-ray images from the whole body including the skull, chest, abdomen, and extremities. The acquired images support medical professionals to make diagnostic and/or therapeutic decisions.
YSIO X.pree is not for mammography examinations.
8. Technological Characteristics and Substantial Equivalence:
The subject device is the same as the predicate device. The software was updated, and two new detectors have been added. The camera model for auto collimation was changed, and the reference device Multix Impact algorithm has been taken over. The new components and features have been tested and do not raise any new concerns of safety and effectiveness. The device remains within the same classification regulation for the same technology as the predicate device. The system software design was completed in accordance with Siemens Quality Management System Design Controls. The scope of internationally recognized standards compliance remains the same.
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Table 8-1: Comparison of the Subject Device (YSIO X.pree VA20) to the PredicateDevice (YSIO X.pree VA10)
| Feature | Predicate device
YSIO X.pree VA10 | Subject device
YSIO X.pree
VA20 | Comment |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Regulation
Description | Stationary X-Ray System | Stationary X-Ray System | Same |
| Regulation Number | 892.1680 | 892.1680 | Same |
| Classification Product
Code | KPR | KPR | Same |
| Indications for use | YSIO X.pree is a device
intended to visualize
anatomical structures by
converting an X-ray pattern
into a visible image.
YSIO X.pree enables
radiographic exposures of
the whole body and may be
used on pediatric, adult and
bariatric patients. It can also
be used for emergency
applications.
YSIO X.pree is not for
mammography
examinations. | The intended use of the device
YSIO X.pree is to visualize
anatomical structures of
human
beings by converting an X-ray
pattern into a visible image.
The device is a digital X-ray
system to generate X-ray
images from the whole body
including the skull, chest,
abdomen, and extremities.
The acquired images support
medical professionals to make
diagnostic and/or therapeutic
decisions.
YSIO X.pree is not for
mammography examinations. | Similar |
| X-Ray | | | |
| Generator | Polydoros R80
65/80 kW | Polydoros R80
65/80 kW | Same |
| X-Ray tube | OPTITOP
150/40/80/HC-100 | OPTITOP
150/40/80/HC-100 | Same |
| X-ray techniques | Radiography | Radiography | Same |
| Collimator | Digital Multileaf
Collimator N | Digital Multileaf
Collimator N | Same |
| Air kerma | Kerma X | Kerma X | Same |
| CARE | Combined
Applications to
Reduce Exposure | Combined
Applications to
Reduce Exposure | Same |
| Touch user interface
on tube suspension
Digital Imaging | touchscreen in landscape
format | touchscreen in landscape
format | Same |
| Feature | Predicate device
YSIO X.pree VA10 | Subject device
YSIO X.pree
VA20 | Comment |
| Fixed detector for
table and wall stand | Trixell pixium 4343RC
"Max Static" | Trixell pixium 4343RC
"Max Static" | Same |
| | Trixell pixium
3543EZh, "MAX wi-D" | Trixell pixium
3543EZh, "MAX wi-D" | Same |
| Large mobile detectors | N/A | Trixell pixium 3543EZ3
"X.wi-D 35" | New for YSIO
X.pree VA20 |
| | N/A | Trixell pixium 4343EZ3
"X.wi-D 43" | New for YSIO
X.pree VA20 |
| Small mobile detector | Trixell pixium 2430EZ
"MAX mini" | Trixell pixium 2430EZ "MAX
mini" | Same |
| | syngo XR | syngo XR | Same |
| | Operating system Windows
10 | Operating system Windows
10 | Same |
| | Operated via touch screen | Operated via touch screen | Same |
| Digital imaging
system | Image processing with
myExam IQ | Image processing with
myExam IQ | Same |
| | AI-based Auto Cropping | AI-based Auto Cropping | Same |
| | Acquisition and Image
processing parameters
selected via clinical
protocols | Acquisition and Image
processing parameters
selected via clinical protocols | Same |
| Other Features and Components | | | |
| Patient Table | Table with fixed detector
and table with bucky | Table with fixed detector and
table with bucky | Same |
| | Standard tabletop and flat
tabletop | Standard tabletop and flat
tabletop | Same |
| Wall stand | Wall stand with fixed
detector and wall stand with
bucky | Wall stand with fixed detector
and wall stand with bucky | Same |
| Camera | Live camera for patient
positioning and collimation | Live camera for patient
positioning and collimation | Similar
New Camera
Model, same
functionality |
| | Auto Thorax Collimation | Auto Thorax Collimation | Different. |
| AI based Automatic
collimation | N/A | Auto Long-Leg/Full-Spine
collimation | Changed to new
algorithm, Auto
Long-Leg/Full-
Spine collimation
added |
| Cropping | AI-based auto cropping | AI-based auto cropping | Same |
| Wireless Remote
Control | Yes, same type | Yes, same type | Same |
| Feature | Predicate device
MULTIX Impact | Subject device
YSIO X.pree VA20 | Comment |
| Camera | Live camera for patient
positioning and collimation | Live camera for patient
positioning and collimation | Same
The camera, used
for MULTIX
Impact, is now used
for YSIO X.pree
VA20 |
| AI based Automatic collimation | Auto Thorax, Auto Long-
Leg/Full-Spine collimation | Auto Thorax, Auto Long-
Leg/Full-Spine collimation | Same
The algorithm, used
in MULTIX Impact,
is also used for
YSIO X.pree VA20 |
40 Liberty Boulevard
Malvern, PA 19355
USA
7
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40 Liberty Boulevard
Malvern, PA 19355
USA
Tel.: +1-888-826-9702
usa.siemens.com/healthineers
8
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Table 8-2: Comparison of the Subject Device (YSIO X.pree VA20) to the Reference Device (Multix Impact) – AI based Automatic Collimation
Summary of Non-Clinical Tests: 9.
The YSIO X.pree was tested and complies with the voluntary standards listed in the table below:
| Table 9: Non-clinical performance testing | |||
|---|---|---|---|
| ------------------------------------------- | -- | -- | -- |
| Standards Development
Organization and Reference
| Number | Title of Standard |
|---|---|
| ANSI AAMI | |
| 60601-1, 2012 Ed. 3.1 | Medical Electrical Equipment - Part 1: General |
| Requirements for Safety | |
| IEC 60601-1-2 2014 Ed 4.1 | Medical Electrical Equipment - Part 1-2: General requirements for |
| basic safety and essential performance - Collateral Standard: | |
| Electromagnetic disturbances - Requirements and tests | |
| IEC 60601-1-3: | |
| Edition 2.1, 2013 | Medical electrical equipment - Part 1-3: General requirements for |
| basic safety and essential performance - Collateral Standard: | |
| Radiation protection in diagnostic X-ray equipment | |
| IEC 60601-2-28, 2017 | Medical electrical equipment - Part 2-28: Particular requirements |
| for the basic safety and essential performance of X-ray tube | |
| assemblies for medical diagnosis |
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| IEC 60601-2-54
2018, Edition 1.2 | Medical electrical equipment - Part 2-54: Particular requirements
for the basic safety and essential performance of X-ray equipment
for radiography and radioscopy |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-6
2020 Ed 3.2 | Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard:
Usability |
| IEC 62366-1 2020 Ed 1.1 | Medical devices – Application of usability engineering tomedical
devices |
| ISO 14971: 2019 | Medical devices - application of risk management tomedical
devices |
| IEC 62304 2015, Ed.1.1 | Medical device software - Software life cycle processes |
| IEC 61910-1: 2014, Ed 1.0 | Medical electrical equipment - Radiation dose documentation -
Part 1: Radiation dose structured reports for radiography and
radioscopy |
| NEMA PS 3.1 - 3.20 2021 | Digital Imaging and Communications in Medicine(DICOM) Set |
| ISO EN ISO 10993-1
Fifth edition 2018 | Biological evaluation of medical devices - Part1: Evaluation and
testing within a risk management process |
The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Requirement Specification Reviews
- Design Reviews
- Integration testing (System verification and validation)
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10. Summary of Clinical Tests:
A Customer Use Test (CUT) was performed at the "Universitätsklinikum Augsburg, Germany, to ensure the acceptance of the design and to gather feedback on the usability of the device on the clinical environment.
The focus of the test was:
- System function and performance-related clinical workflow
- Image quality
- Ease of use
- Overall performance and stability
The results of the clinical test stated that the intended use of the system was met, and the clinical need covered.
General Safety and Effectiveness Concerns: 11.
The Instructions for Use (IFU) are included within the device labeling, and the information provided enables the user to operate the device safely and effectively. Several safety features including visual and audible warnings are incorporated into the system design. In addition, the device is continually monitored, and if an error occurs, the system functions will be blocked, and an error message will be displayed.
Furthermore, the operators are health care professionals familiar with and responsible for the 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 X.pree, that is the subject of this 510(k), is the same as the predicate device. The operating environment is the same and the changes do not affectiveness. Siemens concludes, according to this submission material and the documentation provided, that the YSIO X.pree is substantially equivalent to the predicate device and reference device.
The newly introduced wireless detectors (X.wi-D35 and X.wi D43) were tested during a Clinical Use Test (CUT) at University Hospital Augsburg in Germany according to "Guidance of Submission of 510(k)s for Solid State X-ray Imaging Devices" Document issued on: September 1, 2016. All images acquired with the new detectors were sufficiently acceptable for radiographic usage. Together with the non-clinical testing, it has met the objective of demonstrating substantial equivalence when comparing the Siemens YSIO X.pree VA20 to the Siemens YSIO X.pree VA10 detectors.
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13. Guidance documents
The following FDA guidance documents were utilized in this Premarket Notification:
Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography Document issued on October 20, 2006
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission - Guidance for Industry and Food and Drug Administration Staff Document Issued on September 27, 2023
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
Content of Premarket Submissions for Device Software Functions - Guidance for Industry and FDA Staff Document issued on June 14, 2023
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: Evaluation Substantial Equivalent in Premarket Notifications 510(k) - Guidance for Industry and Food and Drug Administration Staff Document issued on July 28, 2014.
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
Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document issue on August 13, 2013