(94 days)
No
The document describes standard image processing techniques (Filtered Back-Projection, Shift Addition, Iteration) for tomosynthesis reconstruction and mentions software validation according to general software and cybersecurity guidance, but does not mention AI, ML, or related concepts.
No
This device is an X-ray radiography system used for diagnostic imaging, not for treating diseases or conditions. Its intended use is to generate radiographic images for examination.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is intended to "generate diagnostic images by converting x-rays into electronic signals." This directly indicates its role in diagnosis.
No
The device description explicitly states it is an X-ray radiography system consisting of hardware components such as an X-ray high voltage generator, X-ray tube unit, X-ray tube support, and collimator, and can be configured with a radiographic table, stand, and digital radiography system. While it includes software validation, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The RADspeed PRO is an X-ray radiography system. It generates images of the internal structures of the body by passing X-rays through the patient. This is an in vivo (within the living body) imaging technique, not an in vitro diagnostic test.
- Intended Use: The intended use clearly states that the device is for generating radiographic images of various body parts for diagnostic purposes. This involves imaging the patient directly, not analyzing samples from the patient.
Therefore, the RADspeed PRO falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The RADspeed PRO is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed Pro enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The RADspeed PRO uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals. The device is not intended for mammographic applications.
Product codes
KPR, MQB
Device Description
The RADspeed PRO is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The RADspeed PRO can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The RADspeed PRO consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. Optionally, the device is also used to perform tomosynthesis radiography by three different reconstruction modes. Filtered Back-Projection (FBP) mode is used to obtain a tomosynthesis image by performing back-projection after correcting the projection data. Shift Addition (SA) mode is used to obtain a tomosynthesis image at an arbitrary slice plane height by shifting each image according to projection angle of the tube based on the reconstruction height, and by applying image addition processing to them. Iteration (IR) mode is used to reduce metal artifact in tomosynthesis image. FBP mode is generally recommended for all body parts. In case an artifact is observed at joints and other similar places, SA mode may remedy this artifact. In case metal artifact is obviously displayed, IR mode is recommended to reduce metal artifact. This description is the same as our predicate. Key technological characteristics of the main components: X-Ray Generators: Available in 80 kW, 65 kW, and 50 kW versions. Image receptor panels: More recently cleared versions of Fujifilm panels are now employed, except for the tomography option, where the digital receptor panel and all other aspects remain unchanged from the predicate. Details are in the comparison table below.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies
Indicated Patient Age Range
all ages including pediatric patients
Intended User / Care Setting
hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals.
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)
The radiation safety aspects of the device have not changed. The device remains compliant with the FDA Radiation Safety Standards. The following activities were performed as a result of the modifications to the device:
a. The User Manuals were modified to reflect the changes detailed above.
b. Software Validation was performed according to the FDA Guidance Documents: Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug Administration Staff (Basic Documentation Level) AND Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submarket Submissions Guidance for Industry and Food and Drug Administration Staff.
c. EMC and Electrical Safety Testing was performed according to these IEC Standards: Test Specification: EN 60601-1-2:2015 +A1:2021, IEC 60601-1-2:2014 +A1:2020; EN 60601-2-54:2009 +A1:2015 +A2:2019 clause 202; IEC 60601-2-54:2009 +A1:2015 +A2:2018 clause 202. Test Specification: IEC 60601-2-54:2009+A1+A2, IEC 60601-1:2005+A1, IEC 60601-1-3:2008+A1, IEC 60601-1-6:2010+A1, plus a Test Report for National Differences.
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.
0
Image /page/0/Picture/0 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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 23, 2024
Shimadzu Corporation % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES, FL 34114
Re: K233722
Trade/Device Name: RADspeed PRO Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: January 26, 2024 Received: January 26, 2024
Dear Mr. Kamm:
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.
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 803) for 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological 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
510(k) Number (if known) K233722
Device Name RadSpeed Pro
Indications for Use (Describe)
The RADspeed Pro is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed Pro enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The RADspeed Pro uses portable or integrated flat panel detectors to generate diagnostic images by converting x-ravs into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals. The device is not intended for mammographic applications.
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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3
Image /page/3/Picture/0 description: The image shows the text "510(k) Summary K233722" at the top. Below that is the Shimadzu logo, which includes a square symbol with a plus sign inside and the word "SHIMADZU" in bold, sans-serif font. The text and logo are black against a white background.
SHIMADZU CORP. 1, Nishinokyo-Kuwabaracho, Nakagyo-ku, Kyoto City, JAPAN 604-8511 Date submitted: January 15, 2024 Prepared by: Koichi Kataoka, General Manager, Quality Assurance Department, Medical Systems Division. k_koichi@shimadzu.co.jp; Tel +81-75-8231305
-
- Identification of the Device: Trade/Device Names: RADspeed PRO Regulation Number: 21CFR892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: KPR, MQB
-
- Equivalent legally marketed device: K152244 Trade/Device Name: RADspeed PRO Manufacturer: Shimadzu. Regulation Number: 21CFR892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: KPR, MQB
-
- Purpose of Submission: Modified Device. The fundamental technological features are the same for the subject and the predicate systems. The modifications are mainly cosmetic in nature.
-
- Device Description: The RADspeed PRO is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The RADspeed PRO can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The RADspeed PRO consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. Optionally, the device is also used to perform tomosynthesis radiography by three different reconstruction modes. Filtered Back-Projection (FBP) mode is used to obtain a tomosynthesis image by performing back-projection after correcting the projection data. Shift Addition (SA) mode is used to obtain a tomosynthesis image at an arbitrary slice plane height by shifting each image according to projection angle of the tube based on the reconstruction height, and by applying image addition processing to them. Iteration (IR) mode is used to reduce metal artifact in tomosynthesis image. FBP mode is generally recommended for all body parts. In case an artifact is observed at joints and other similar places, SA mode may remedy this artifact. In case metal artifact is obviously displayed, IR mode is recommended to reduce metal artifact. This description is the same as our predicate. Key technological characteristics of the main components: X-Ray Generators: Available in 80 kW, 65 kW, and 50 kW versions. Image receptor panels: More recently cleared versions of Fujifilm panels are now employed, except for the tomography option, where the digital receptor panel and all other aspects remain unchanged from the predicate. Details are in the comparison table below.
4
Software Description: These functions are unchanged:
- DICOM Connection Software,
- Basic Grayscale Print Management o
- Media Storage O
- Image Processing Software
- o Multi-objective Frequency Processing
- Grid Removal Processing o
- o Shuttering Processing
- о Gradation Processing
- O Dynamic Range Control Processing
- Tomographic Artifact Suppression Processing o
- Flexible Noise Control o
- Function Software
- o Retake Analysis Software
But the fundamental technological features are the same for the subject and the predicate systems. The changes are described in Section 6, below.
-
- Indications for Use: The RADspeed PRO is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed Pro enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The RADspeed PRO uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals. The device is not intended for mammographic applications.
-
- Comparison of Technological Characteristics with the predicate device: At a high level, new device and its predicate device is based on the following same technological elements: Energy emission to the patient – X-ray Power requirement; Environment; Mechanism to generate X-ray; Mechanism to acquire, process and store image data; Use of the hardware components. The imaging components were replaced by more recently cleared digital x-ray receptor panels made by FUJIFILM. A detailed list is provided in the comparison table below. (The tomography function remains completely unmodified.) The following technological differences exist between modified and its predicate device:
A larger LCD display is employed in the collimator.
A larger LCD display is employed in the generator control.
A video camera has been added to the collimator to assist in patient positioning. Functions include: movie display, rotation, zooming, guideline overlay.
A wireless remote control collimator control has been added.
A wireless remote exposure control has been added.
The software for the two touchscreens (Collimator and Generator Control) has been updated.
Infrastructure: Change programming language (C => C, Golang, JavaScript)
5
Architecture: Port to new OS (Real-time OS => Linux)
The software functionality remains unchanged.
The generator technical characteristics have not changed (kW, kV, mA, exposure times) Imaging components: The updated versions of the FUJIFILM X-ray receptor panels (since 2015) have been employed except for tomography which remains unchanged. All the imaging panels have 510(k) clearance as shown in the table below. The panels all use the same integration software which comes with the panel. The integration software, although updated, has the identical functionality to the predicate. In conclusion, the main technological characteristics have not changed. The modified system has a more modern, updated "look."
| Name of
Modified
| Item | Predicate Device RADspeed PRO K152244 | Modified Device RADspeed PRO K233722 |
|---|---|---|
| Indications | ||
| for Use | The RADspeed PRO is intended to generate digital or | |
| conventional radiographic images of the skull, spinal | ||
| column, chest, abdomen, extremities, and other body | ||
| parts of human anatomies in all routine radiography | ||
| examinations. The RADspeed Pro enables radiographic | ||
| or tomographic exposures of the whole body of all | ||
| ages including pediatric patients. Exposures may be | ||
| taken with the patient sitting, standing, or lying in the | ||
| prone or supine position. The RADspeed PRO uses | ||
| portable or integrated flat panel detectors to generate | ||
| diagnostic images by converting x-rays into electronic | ||
| signals. The device is also designed to be used with | ||
| conventional film/screen or computed radiography | ||
| (CR) cassettes. The Tomosynthesis option is intended | ||
| to generate tomographic images of human anatomies. | ||
| Tomosynthesis technique is used to produce a specific | ||
| cross-sectional plane of the body by reconstruction of | ||
| tomographic acquisition. The device is intended to be | ||
| used in hospitals, clinics, imaging centers, and/or | ||
| other healthcare facilities by qualified/trained | ||
| professionals. The device is not intended for | ||
| mammographic applications | The RADspeed PRO is intended to generate digital or | |
| conventional radiographic images of the skull, spinal | ||
| column, chest, abdomen, extremities, and other body | ||
| parts of human anatomies in all routine radiography | ||
| examinations. The RADspeed Pro enables radiographic | ||
| or tomographic exposures of the whole body of all | ||
| ages including pediatric patients. Exposures may be | ||
| taken with the patient sitting, standing, or lying in the | ||
| prone or supine position. The RADspeed PRO uses | ||
| portable or integrated flat panel detectors to generate | ||
| diagnostic images by converting x-rays into electronic | ||
| signals. The device is also designed to be used with | ||
| conventional film/screen or computed radiography | ||
| (CR) cassettes. The Tomosynthesis option is intended | ||
| to generate tomographic images of human anatomies. | ||
| Tomosynthesis technique is used to produce a specific | ||
| cross-sectional plane of the body by reconstruction of | ||
| tomographic acquisition. The device is intended to be | ||
| used in hospitals, clinics, imaging centers, and/or | ||
| other healthcare facilities by qualified/trained | ||
| professionals. The device is not intended for | ||
| mammographic applications (Unchanged.) | ||
| Name of | ||
| Modified | ||
| Item | Predicate Device RADspeed PRO K152244 | Modified Device RADspeed PRO K233722 |
| Over-head | ||
| Tube crane | ||
| control | Image: Predicate Device RADspeed PRO K152244 Over-head Tube crane control | CH-200(L) Touch screen now rectangular 12" |
| instead of square 7" | ||
| Image: Modified Device RADspeed PRO K233722 Over-head Tube crane control | ||
| Generator | ||
| Console | 6.7" x 5" display, 640 x 480 pixels | |
| Image: Predicate Device RADspeed PRO K152244 Generator Console | 8.5"d x 5.4" display, 1280 x 800 pixels | |
| Larger display, but same content | ||
| Image: Modified Device RADspeed PRO K233722 Generator Console | ||
| Name of | ||
| Modified | ||
| Item | Predicate Device RADspeed PRO K152244 | Modified Device RADspeed PRO K233722 |
| Added | ||
| Camera | ||
| Option | ||
| in Colli- | ||
| mator | R-300 Collimator Before Modification, no camera | |
| port | ||
| Bottom View Shown | ||
| Image: R-300 Collimator Before Modification | Video Camera (HD resolution, 1280x720) added | |
| On front of R-300 Collimator, now called RC-300 | ||
| Bottom View shown | ||
| Camera Functions: Patient position, patient | ||
| movement, plus: The following guide lines are | ||
| superimposed on the camera image: Gridline, | ||
| Exposure field, FPD effective area (Described in | ||
| Section 10 of the System Users Manual) | ||
| Image: Camera and Control unit in cover | ||
| Remote | ||
| Controller | Wired | |
| Image: Wired Remote Controller | Wireless Remote Controller (Page 127 and 139 of | |
| the Tube Support User Manual) | ||
| Shown in holder Closeup View | ||
| Image: Wireless Remote Controller | ||
| Name of | ||
| Modified | ||
| Item | Predicate Device RADspeed PRO K152244 | Modified Device RADspeed PRO K233722 |
| Exposure | ||
| switch, | ||
| part of | ||
| Generator | ||
| assembly | Wired | |
| Wired, shown attached to control panel | ||
| Image: Control panel with wired exposure switch | Wireless Option: Battery operated Exposure | |
| Switch with holder, Described in Generator User | ||
| Manual | ||
| Image: Wireless exposure switch and charging station | ||
| SOFTWARE | X | The software for the two touchscreens |
| (Colllimator and Generator Control) has been | ||
| updated. | ||
| Infrastructure: Change programming language | ||
| (C ⇒ C, Golang, JavaScript) | ||
| Architecture: Port to new OS , | ||
| (Real-time OS ⇒ Linux) | ||
| The software functionality remains unchanged. | ||
| X-Ray | ||
| Generator | ||
| Power | Three available models: | |
| 50 kW (100 kV, 500 mA) | ||
| 65 kW (100 kV, 650 mA) | ||
| 80 kW (100 kV, 800 mA) | UNCHANGED | |
| X-Ray | ||
| Generator | ||
| kV | 40 to 150 kV | UNCHANGED |
| Exposure | ||
| Times | 81 positions, 0.001 to 10 sec | UNCHANGED |
| Current | (Depending on model) | |
| 10-500 mA (12 positions) | ||
| 10-630 mA (12 positions) | ||
| 10-800 mA (12 positions) | UNCHANGED | |
| Filtration | Minimum total filtration | |
| IEC 60601-2-28:2017 | ||
| 1.7 mm Al/75 kV (Including added filter) | UNCHANGED | |
| Name of | ||
| Modified | ||
| Item | Predicate Device RADspeed PRO K152244 | Modified Device RADspeed PRO K233722 |
| DR System | DR-ID 900 | UNCHANGED |
| FPD Flat | ||
| panel | ||
| detectors | For Tomography: DR-ID 911SE | |
| For Radiography: | ||
| DR-ID 601SE | ||
| DR-ID 602SE | ||
| DR-ID 611SE | For Tomography: DR-ID 911SE (SAME) | |
| For Radiography: | ||
| DR-ID 1201SE (K142003) | ||
| DR-ID 1202SE (K142003) | ||
| DR-ID 1211SE (K142003) | ||
| DR-ID 1212SE (K142003) | ||
| DR-ID 1831SE (K192932) | ||
| DR-ID 1832SE (K192932) | ||
| DR-ID 1811SE (K192932) | ||
| DR-ID 1812SE (K192932) |
6
7
8
9
-
- Performance Testing Information: The radiation safety aspects of the device have not changed. The device remains compliant with the FDA Radiation Safety Standards. The following activities were performed as a result of the modifications to the device:
- a. The User Manuals were modified to reflect the changes detailed above.
- b. Software Validation was performed according to the FDA Guidance Documents: Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug Administration Staff (Basic Documentation Level) AND Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff.
- c. EMC and Electrical Safety Testing was performed according to these IEC Standards: Test Specification: EN 60601-1-2:2015 +A1:2021, IEC 60601-1-2:2014 +A1:2020; EN 60601-2-54:2009 +A1:2015 +A2:2019 clause 202; IEC 60601-2-54:2009 +A1:2015 +A2:2018 clause 202. Test Specification: IEC 60601-2-54:2009+A1+A2, IEC 60601-1:2005+A1, IEC 60601-1-3:2008+A1, IEC 60601-1-6:2010+A1, plus a Test Report for National Differences.
-
- Conclusion: The non-clinical data supports the safety of the device and the hardware and software verification and validation demonstrate that new device should performs as intended in the specified use. Based on our risk analysis and bench testing, the differences do not affect its clinical safety or effectiveness. From the result of our risk analysis, software verification and validation, and nonclinical testing discussed above, it is our conclusion that, - RADspeed PRO is substantially equivalent to the legally marketed predicate devices K152244. The fundamental technological features are the same for the subject and the predicate systems. Therefore, new device is as safe, as effective, and performs as well as or better than the predicate device.