(54 days)
No
The summary describes a mobile X-ray unit and its components, focusing on hardware, safety standards, and integration with previously cleared digital panels. There is no mention of AI or ML in the device description, intended use, performance studies, or any other section.
No
This device is for taking diagnostic radiographic exposures, which means it aids in diagnosis rather than providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for taking diagnostic radiographic exposures."
No
The device description explicitly states it is a "mobile x-ray unit" and details hardware components like a generator, battery, motor drive, and digital image acquisition panels. While it includes software for integration and workflow, it is fundamentally a hardware device with integrated software, not a software-only medical device.
No, 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.
- Device Function: The provided description clearly states that this device is a mobile x-ray unit. Its function is to take radiographic exposures of various body parts using X-rays. This is an in vivo diagnostic method (performed on a living organism), not an in vitro method.
- Intended Use: The intended use is for taking diagnostic radiographic exposures, which is consistent with an X-ray machine, not an IVD.
- Device Description: The description details the components of an X-ray system (mobile unit, generator, digital image acquisition panels), not the components of an IVD.
- Testing: The testing described focuses on radiation safety, electrical safety, EMC, and mechanical performance, which are relevant to an X-ray machine, not an IVD.
Therefore, based on the provided information, this device is a medical imaging device used for diagnostic purposes, but it is not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
Product codes (comma separated list FDA assigned to the subject device)
IZL, MOB
IZL, MQB
Device Description
RadPRO® Mobile 40kW and RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR are mobile x-ray units that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone for exposures with battery assisted motor drive for the greatest ease in imaging. Five different models of digital image acquisition panels are offered: Canon CXDI 401C Wireless, Canon CXDI 701C Wireless, Canon CXDI 801C Wireless. All of the Canon panels and the associated software have been cleared by FDA, (K131106 and K133693) so integration with the mobile system was straightforward. The device complies with the US Federal Safety Performance Standard and is UL listed. The key differences between the modified device and the predicate device are as follows:
- The FLEXPLUS version has a telescoping Tubestand which enhances visibility while transporting the unit.
- We are offering updated versions of the Canon Digital X-Ray Panels, as listed above and shown in the comparison table below.
- We have added a second personal computer board which permits "Enhanced Work Flow" capability. The second, independent computer is configured to run a second, independent software system, (to be supplied by the user) to allow a user to toggle to a Work Flow environment for ease-of-use in mobile X-ray systems. This second computer is configured to be a "slave" to the X-ray system software, including both Canon CXDI and Sedecal Integration software (e.g., the second computer is turned on and off by the X-ray System's power status). The second computer and its Windows environment is specified with sufficient computing requirements to enable third-party client software to be installed that could include RIS, QC and PACS communications.
- We have added what we call a "DAS", a distributed antenna system that enhances the detectability of the accompanying detectors, both in range and sensitivity, also increasing the overall wireless sensitivity by utilizing 4 sector antennas.
- We have updated the User Manual to reflect the changes made to the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
skull, spinal column, extremities, and other body parts.
skull, spinal column, chest, abdomen, extremities, and other body parts.
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician / patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater.
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)
Bench, test laboratory results, and clinical image comparisons indicate that the new device is as safe and effective as the predicate devices. All digital panels have previous FDA clearance and are provided unmodified.
Laboratory testing included performance testing to the DHHS Radiation Safety Performance Standard, Electrical Safety per IEC-60601. EMC per IEC-60601-1-2; IEC 60601-1-3 Radiation protection in diagnostic X-ray equipment, IEC 60601-2-54 Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment for Radiography and Radioscopy, and FCC Parts 15 and 18. Software integration testing (enhanced workflow) was documented and a detailed risk analysis was performed. Test images were obtained to confirm total system functionality. Every unit manufactured undergoes thorough performance testing which includes visual and configuration testing, hi-pot testing, hi-pot testing, power supply testing, (batteries, etc.), generator controls (voltage, current, timing), and image acquisition. Additional Wi-Fi testing was done to verify the functionality of internal Wi-Fi antennas. Mechanical testing of the new telescoping Tubestand was performed.
Summary of Clinical Testing: Not required because all of the proposed digital panels have prior FDA clearance. Sample images were verified by a Board Certified Radiologist.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2016
SEDECAL SA % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K161345
Trade/Device Name: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL, MOB Dated: June 28, 2016 Received: June 30, 2016
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161345
Device Name
RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR
Indications for Use (Describe)
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) Summary 510(k) Number K161345 SEDECAL SA C/ Pelaya, 9 - 13, Pol. Ind. Río de Janeiro 28110 Algete, Madrid, España (Spain) Tel.- +34 91 6280544 Fax.- +34 91 6280574 Date Prepared: June 28, 2016 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager
1. Identification of the Device:
Trade/Device Name: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL and MQB Common/Usual Name: Digital Mobile Diagnostic X-Ray System
2. Equivalent legally marketed device: K101517
Trade/Device Name: Sedecal Mobile Digital Diagnostic X-Ray Systems (various models) Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL and MQB Common/Usual Name: Digital Mobile Diagnostic X-Ray System
-
- Indications for Use (intended use) Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
-
- Description of the Device: RadPRO® Mobile 40kW and RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR are mobile x-ray units that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone for exposures with battery assisted motor drive for the greatest ease in imaging. Five different models of digital image acquisition panels are offered: Canon CXDI 401C Wireless, Canon CXDI 701C Wireless, Canon CXDI 801C Wireless. All of the Canon panels and the associated software have been cleared by FDA, (K131106 and K133693) so integration with the mobile system was straightforward. The device complies with the US Federal Safety Performance Standard and is UL listed. The key differences between the modified device and the predicate device are as follows:
- 4.1. The FLEXPLUS version has a telescoping Tubestand which enhances visibility while transporting the unit.
- 4.2. We are offering updated versions of the Canon Digital X-Ray Panels, as listed above and shown in the comparison table below.
4
- 4.3. We have added a second personal computer board which permits "Enhanced Work Flow" capability. The second, independent computer is configured to run a second, independent software system, (to be supplied by the user) to allow a user to toggle to a Work Flow environment for ease-of-use in mobile X-ray systems. This second computer is configured to be a "slave" to the X-ray system software, including both Canon CXDI and Sedecal Integration software (e.g., the second computer is turned on and off by the X-ray System's power status). The second computer and its Windows environment is specified with sufficient computing requirements to enable third-party client software to be installed that could include RIS, QC and PACS communications.
- 4.4. We have added what we call a "DAS", a distributed antenna system that enhances the detectability of the accompanying detectors, both in range and sensitivity, also increasing the overall wireless sensitivity by utilizing 4 sector antennas.
- 4.5. We have updated the User Manual to reflect the changes made to the device.
-
- Safety and Effectiveness, comparison to predicate device. Bench, test laboratory results, and clinical image comparisons indicate that the new device is as safe and effective as the predicate devices. All digital panels have previous FDA clearance and are provided unmodified.
| Characteristic | Sedecal Easy Moving Digital
K101517 | RadPRO® Mobile 40kW; RadPRO® Mobile
40kW FLEXPLUS, Model SM-40HF-B-D-VIR
K161345 |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Intended for use by a
qualified/trained doctor or
technician on both adult and
pediatric subjects for taking
diagnostic radiographic exposures
of the skull, spinal column, chest,
abdomen, extremities, and other
body parts. Applications can be
performed with the patient sitting,
standing, or lying in the prone or
supine position. | SAME, adding FDA requested language:
Not for mammography. |
| Configuration | Battery or line operated mobile | SAME, now with telescopic tube mount
(FLEX PLUS) (see photo below) |
| Performance
Standard | 21 CFR 1020.30 | SAME |
| Generator | High frequency made by Sedecal | SAME |
| Generator
power level | Four available power levels:
20 KW, 32 KW, 40 KW, 50 KW | 40 kW (One power level) |
| Collimator | Ralco R221 DHHS Manual
Collimator | SAME |
| Characteristic | Sedecal Easy Moving Digital
K101517 | RadPRO® Mobile 40kW; RadPRO® Mobile
40kW FLEXPLUS, Model SM-40HF-B-D-VIR
K161345 |
| Image
acquisition | Trixell 3543pR: (Wireless)
Pixel size 144 $ μ $ m/2372 x 3000
pixels or
Varian 4336R
Pixel size 139 $ μ $ m/3072 x 2560
pixels | Canon CXDI 401C Wireless (CSI) K133693
Pixel size: 125 $ μ $ m 3320 × 3408 pixels
Canon CXDI 701C Wireless (CSI) K131106
Pixel size: 125 $ μ $ m 2800 × 3408 pixels
Canon CXDI 801C Wireless (CSI) K131106
Pixel size: 125 $ μ $ m 2800 × 2192 pixels |
| Software | dicomPACS®DXR | Canon control software CXDI-NE |
| Connection | Ethernet or Wireless Wi-Fi | SAME |
| DICOM | YES | YES |
| Workflow | Not applicable | Enhanced Work Flow via second PC. |
| Power Source | AC Line or Rechargeable Battery | SAME |
| Electrical
safety and
EMC | Electrical Safety per IEC-60601. UL
listed; EMC per IEC-60601-1-2;
IEC 60601-1-3 Radiation protection
in diagnostic X-ray equipment
IEC 60601-2-54 Particular
Requirements For The Basic Safety
And Essential Performance Of X-Ray
Equipment for Radiography and
Radioscopy | SAME |
| Standards
(Other than
Electrical and
EMC) | Wi-Fi 802.11b/g | Wi-Fi 802.11b/g and:
FCC Rules and Regulations 47 CFR Chapter I
Part 15 Subpart B; Part 18 Subpart C ICES-
003 ISSUE 5 (2012) & ICES-001 ISSUE 4
(2014) & ANSI C63.4-2009. |
| Wi-Fi
communication
with detectors | One single antenna | "DAS" distributed Wi-Fi antenna system |
| Characteristic | Sedecal Easy Moving Digital
K101517 | RadPRO® Mobile 40kW; RadPRO® Mobile
40kW FLEXPLUS, Model SM-40HF-B-D-VIR
K161345 |
| Photos | Image: Sedecal Easy Moving Digital K101517 | Image: RadPRO® Mobile
Image: RadPRO® Mobile Flex Plus |
6. Substantial Equivalence Chart
5
6
-
- Summary of Laboratory Testing and Bench Testing: Laboratory testing included performance testing to the DHHS Radiation Safety Performance Standard, Electrical Safety per IEC-60601. EMC per IEC-60601-1-2; IEC 60601-1-3 Radiation protection in diagnostic X-ray equipment, IEC 60601-2-54 Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment for Radiography and Radioscopy, and FCC Parts 15 and 18. Software integration testing (enhanced workflow) was documented and a detailed risk analysis was performed. Test images were obtained to confirm total system functionality. Every unit manufactured undergoes thorough performance testing which includes visual and configuration testing, hi-pot testing, hi-pot testing, power supply testing, (batteries, etc.), generator controls (voltage, current, timing), and image acquisition. Additional Wi-Fi testing was done to verify the functionality of internal Wi-Fi antennas. Mechanical testing of the new telescoping Tubestand was performed.
7
-
- Summary of Clinical Testing: Not required because all of the proposed digital panels have prior FDA clearance. Sample images were verified by a Board Certified Radiologist.
-
- Conclusion After analyzing bench and laboratory testing to applicable standards, it is the conclusion of Sedecal SA that the modified Sedecal Mobile X-Ray Systems are as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices.