(28 days)
Not Found
No
The document describes a mobile x-ray system focused on hardware improvements (batteries, maneuverability) and basic control systems. There is no mention of AI, ML, image processing, or any software features that would suggest the use of such technologies. The document explicitly states that imaging hardware and software are not supplied with the unit.
No
The device is described as a "mobile diagnostic x-ray system" used for "taking diagnostic exposures" of various body parts. It does not mention any therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states that this is a "mobile diagnostic x-ray system intended for use... for taking diagnostic exposures".
No
The device is a mobile diagnostic x-ray system, which is a hardware device. The description explicitly details hardware components like the x-ray generator, batteries, motors, and mechanical movements. While it mentions an internal computer and Ethernet interface, it also states that imaging hardware and software are not supplied with the unit and are the responsibility of the purchaser.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that this is a mobile diagnostic x-ray system for taking diagnostic exposures of various body parts. This is an in vivo diagnostic procedure, meaning it is performed on a living organism.
- Device Description: The description details an x-ray system, which generates radiation to create images of the internal structures of the body. This is consistent with in vivo imaging, not in vitro testing of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to testing biological samples (like blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
Therefore, this device falls under the category of medical imaging devices used for in vivo diagnosis, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
This is a mobile diagnostic x-ray system intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic 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
IZL
Device Description
This is a battery powered mobile diagnostic x-ray system which is provided without the digital x-ray acquisition systems used on our predicate model. The unit is provided with Lithium batteries to supply both X-ray generator for X-ray exposures and motors for movements instead of the Sealed Lead Acid batteries of the predicate model. This system has been made lighter and therefore more maneuverable. Lithium batteries provide a much lower charging time and more autonomy in standby. The indication for use remains the same as the predicate. The x-ray generator has been adapted to the new power supply based on Lithium batteries. The main features of this equipment are:
a) A solid and ergonomic design. Easy operation, safety and precision of all positioning movements relative to the position of the patient.
b) Standard electrical outlet operation with single-phase lines at 100 -- 240 V*. Automatic line voltage compensation.
c) Head-Assembly rotation in relation to its transversal axis (±180°) and horizontal axis (120°). Collimator rotation in relation to its vertical axis (±90°).
d) Controls for lock release of Rotating Column and Telescopic Arm.
e) Column rotation in relation to its vertical axis (±317°), telescopic and vertical motion of the Arm.
f) X-ray Handswitch for X-ray exposures and Collimator Light.
Infrared Remote X-ray Handswitch (optional) for X-ray exposures and Collimator Light. g)
h) Dosimetry (optional):
i) DAP reading with an Ion Chamber. i)
ii) Calculated DAP (eDAP).
i) Manual Collimation.
Tube protection circuitry prolongs Tube life and increases system performance. i)
Equipped with closed loop control of X-ray Tube current, kVp and filaments, which minimize k) potential errors and the need for readjustments.
There is no imaging hardware or software supplied with the unit. That is the responsibility of the purchaser. The x-ray flat panel detectors (an integral part of a complete diagnostic system) are not part of the SM-IV device and must me provided separately by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
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
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)
Summary of non-clinical testing: A system was assembled and tound to be operating properly. Firmware was essentially unchanged except a small adaptation required by lithium batteries. Because the system has an Ethernet interface, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff. The internal computer is available for the installation of user supplied imaging software.
The SM-IV Battery Mobile X-Ray Unit has been tested to be in compliance with the following International Standards:
IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION FDA #19-49
IEC 60601-1-2:2020 + A1:2020 (Edition 4.1) FDA #19-36
IEC TR 60601-4-2 (Edition 1.0 2016-05) FDA #19-19
IEC 60601-1-3:2008+A1:2013 + A2: 2021(Edition 2.1) FDA 12-336
IEC 60601-2-54:2009+A1:2015 + A2:2018 (Edition 1.2) FDA 12-317
IEC 60601-2-28:2017 (Edition 3.0) FDA 12-309
IEC 60601-1-6:2010 + A1:2013 + A2: 2020 (Edition 3.2) FDA 5-132
IEC 62304:2006 + A1:2015 (Edition 1.1) FDA 13-79
Summary of clinical testing: Clinical testing was not required to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
August 21, 2023
Image /page/0/Picture/1 description: The image shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.
Sedecal SA % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114
Re: K232185
Trade/Device Name: SM-IV Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: July 17, 2023 Received: July 24, 2023
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.
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
1
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
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
SM-IV
Indications for Use (Describe)
This is a mobile diagnostic x-ray system intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic 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.
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
510(k) Summary: 510(k) Number K232185
Image /page/3/Picture/1 description: The image is a logo for SEDECAL. The logo is a teal rectangle with rounded corners. Inside the rectangle is a white graphic of a person sitting at a desk, and the word "SEDECAL" in white letters.
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: August 4, 2023 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager
-
- Identification of the Device: Trade/Device Name: SM-IV Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL. Common/Usual Name: Mobile Diagnostic X-Ray System
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- Equivalent legally marketed device: K212291 Trade/Device Name: PHOENIX Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
-
- Indications for Use: This is a mobile diagnostic x-ray system 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: This is a battery powered mobile diagnostic x-ray system which is provided without the digital x-ray acquisition systems used on our predicate model. The unit is provided with Lithium batteries to supply both X-ray generator for X-ray exposures and motors for movements instead of the Sealed Lead Acid batteries of the predicate model. This system has been made lighter and therefore more maneuverable. Lithium batteries provide a much lower charging time and more autonomy in standby. The indication for use remains the same as the predicate. The x-ray generator has been adapted to the new power supply based on Lithium batteries. The same. The main features of this equipment are:
- a) A solid and ergonomic design. Easy operation, safety and precision of all positioning movements relative to the position of the patient.
- b) Standard electrical outlet operation with single-phase lines at 100 -- 240 V*. Automatic line voltage compensation.
4
- c) Head-Assembly rotation in relation to its transversal axis (±180°) and horizontal axis (120°). Collimator rotation in relation to its vertical axis (±90°).
- d) Controls for lock release of Rotating Column and Telescopic Arm.
- e) Column rotation in relation to its vertical axis (±317°), telescopic and vertical motion of the Arm.
- f) X-ray Handswitch for X-ray exposures and Collimator Light.
- Infrared Remote X-ray Handswitch (optional) for X-ray exposures and Collimator Light. g)
- h) Dosimetry (optional):
- DAP reading with an Ion Chamber. i)
- ii) Calculated DAP (eDAP).
- i) Manual Collimation.
- Tube protection circuitry prolongs Tube life and increases system performance. i)
- Equipped with closed loop control of X-ray Tube current, kVp and filaments, which minimize k) potential errors and the need for readjustments.
There is no imaging hardware or software supplied with the unit. That is the responsibility of the purchaser. The x-ray flat panel detectors (an integral part of a complete diagnostic system) are not part of the SM-IV device and must me provided separately by the user.
| Characteristic | Predicate: K212291 PHOENIX | SM-IV |
|---|---|---|
| Indications | ||
| for Use: | This is a digital mobile diagnostic x-ray system | |
| 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 | This is a mobile diagnostic x-ray system | |
| 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. | ||
| (Same) | ||
| Configuration | Mobile System with digital x-ray panel and | |
| image acquisition computer | SAME but no image acquisition software or | |
| hardware s supplied. | ||
| X-ray | ||
| Generator(s) | 20, 32, 40 kW and 50 kW Monoblock generator | |
| kV range: from 40 kV to 150 kV | ||
| mA range: 10 mA – 630mA | ||
| mAs range: from 0.1 mAs to 500 mAs | 20, 32, 40 kW and 50 kW Monoblock | |
| generator | ||
| kV range: from 40 kV to 150 kV | ||
| mA range: 10 mA – 630mA | ||
| mAs range: from 0.1 mAs to 500 mAs | ||
| (Same) | ||
| Collimator | Ralco R108F | Same |
| Characteristic | Predicate: K212291 PHOENIX | SM-IV |
| Photos | Image: K212291 PHOENIX | Image: SM-IV |
| Touch screen | ||
| control | Yes, 19" | 19" or 21'5" |
| Motorized | ||
| movement | Included | SAME |
| Meets US | ||
| Performance | ||
| Standard | YES 21 CFR 1020.30 | SAME |
| Power Source | Universal power supply, from 100 V~ to 240 | |
| V~. 1 phase | SAME | |
| Type of | ||
| Batteries | Sealed Lead batteries | Lithium batteries |
| Standby | ||
| autonomy | The Mobile Unit in Stand-Alone (disconnected | |
| from the mains) will be 100% discharged from | ||
| full charge in approximately: 11 hours | The Mobile Unit in Stand-Alone (disconnected | |
| from the mains) will be 100% discharged | ||
| from full charge in approximately: 17 hours . | ||
| Charging time | The required time for the Batteries to be 100% | |
| charged is approximately: 8 hours. | The required time for the Battery to be 100% | |
| charged is approximately: 4 hours. | ||
| Imaging | ||
| Software | Konica-Minolta control software CS-7 | |
| (K151465 or K172793) OR Konica-Minolta | ||
| control software Ultra. | Not included | |
| Digital detector | ||
| Interface | Ethernet or Wi-Fi wireless | Not applicable |
| Size | 122 x 540 x 223 cm | 122 x 540 x 222 cm |
| Weight | 520 kg | 450 kg. |
| Digital | ||
| Detectors | AeroDR Series | Not included. |
5) Substantial Equivalence Chart
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6
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- The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness. Safety and Effectiveness, comparison to predicate device. The results of bench testing indicate that the new device is as safe and effective as the predicate device. Here is a summary of the changes we made to the device: The battery technology has changed from sealed lead acid to lithium and the digital imaging components have been removed to allow for various other previously cleared digital receptor panels to be installed by trained service technicians.
-
- Summary of non-clinical testing: A system was assembled and tound to be operating properly. Firmware was essentially unchanged except a small adaptation required by lithium batteries. Because the system has an Ethernet interface, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff. The internal computer is available for the installation of user supplied imaging software.
The SM-IV Battery Mobile X-Ray Unit has been tested to be in compliance with the following International Standards:
IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION FDA #19-49 IEC 60601-1-2:2020 + A1:2020 (Edition 4.1) FDA #19-36 IEC TR 60601-4-2 (Edition 1.0 2016-05) FDA #19-19 IEC 60601-1-3:2008+A1:2013 + A2: 2021(Edition 2.1) FDA 12-336 IEC 60601-2-54:2009+A1:2015 + A2:2018 (Edition 1.2) FDA 12-317 IEC 60601-2-28:2017 (Edition 3.0) FDA 12-309 IEC 60601-1-6:2010 + A1:2013 + A2: 2020 (Edition 3.2) FDA 5-132 IEC 62304:2006 + A1:2015 (Edition 1.1) FDA 13-79
-
- Summary of clinical testing: Clinical testing was not required to establish substantial equivalence.
-
- Conclusion: After analyzing bench and non-clinical tests, it is the conclusion of Sedecal SA. that the SM-IV Diagnostic Mobile X-Ray System is as safe and effective as the predicate device, has few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.