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.

Device Description

This is a new type of our previous predicate mobile PhoeniX. The predicate PhoeniX mobile is interfaced with Canon Digital X-ray panels and Canon control software CXDI-NE. The new PhoeniX mobile is interfaced with Konica – Minolta Digital X-ray panels and CS-7 or Ultra software image acquisition. Phoenix mobile systems will be marketed in the USA by KONICA MINOLTA. Models with the CS-7 Software will be marketed as AeroDR Tran-X Models with the Ultra Software will be marketed as mKDR II. The compatible digital receptor panels are the same for either model. The CS-7 software was cleared under K151465/K172793, while the Ultra software is new. The CS-7 is a DIRECT DIGITIZER used with an image diagnosis device, medical imaging device and image storage device connected via the network. This device digitally processes patient images collected by the medical imaging device to provide image and patient information. By contrast the Ultra-DR software is designed as an exam-based modality image acquisition tool. Ultra-DR software and its accompanying Universal Acquisition Interface (UAI) were developed to be acquisition device independent. Basic Features of the software include Modality Worklist Management (MWM) / Modality Worklist (MWL) support, DICOM Send, CD Burn, DICOM Print, and Exam Procedure Mapping. Ultra Software is designed to increase patient throughput while minimizing data input errors. Ultra is made up of multiple components that increase efficiency while minimizing errors. The main components of Ultra are the Worklist, Acquisition Interface and Configuration Utility. These components combine to create a Stable, Powerful, and Customizable Image capture system. The intuitive graphical user interface is designed to improve Radiology, Technologist accuracy, and image quality. Worklist and Exam screens were developed to allow site specific customizations to seamlessly integrate into existing practice workflows.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the PHOENIX Digital Mobile Diagnostic X-Ray System, based on the provided text.

Based on the provided document, the PHOENIX device is a digital mobile diagnostic x-ray system, and the submission is for a modification to an existing cleared device (K192011 PHOENIX). The "study" described is primarily non-clinical bench testing to demonstrate that the modified system, with new digital flat-panel detectors (AeroDR series) and new acquisition software (Ultra), is as safe and effective as the predicate device. No clinical study information is provided in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for the overall device performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The comparison is primarily in the form of feature similarity and compliance with international standards for safety and electrical performance.

Characteristic	Predicate (K192011 PHOENIX)	PHOENIX (Proposed)	Comparison of Performance
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, 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 (includes device description as requested by FDA)	Met: Indications for use are identical, signifying no change in intended clinical application.
Configuration	Mobile System with digital x-ray panel and image acquisition computer	SAME	Met: Basic physical configuration remains unchanged.
X-ray Generator(s)	kW rating: 20 kW, 32 kW, 40 kW and 50 kW. kV range: from 40 kV to 150 kV in 1 kV steps. mA range: from 10 mA to 630 mA / 640 mA / 650 mA.	SAME	Met: The X-ray generator specifications are identical, ensuring consistent radiation output characteristics.
Collimator	Ralco R108F	Ralco R108F	Met: The collimator model is identical, ensuring consistent radiation field shaping.
Meets US Performance Standard	YES 21 CFR 1020.30	SAME	Met: Compliance with the US Performance Standard for diagnostic X-ray systems is maintained.
Power Source	Universal power supply, from 100 V~ to 240 V~. 1 phase, 1.2 kVA	SAME	Met: Power supply specifications are identical.
Software	Canon control software CXDI-NE	Konica-Minolta control software CS-7 (K151465 or K172793) OR Konica-Minolta control software Ultra.	Met (by validation): New software (Ultra) validated according to FDA Guidance. CS-7 was previously reviewed. This is a key change, and compliance is asserted through specific software validation.
Panel Interface	Ethernet or Wi-Fi wireless	SAME	Met: Interface method is unchanged.
Image Area Sizes (Detectors)	CANON CXDI-401C 16"x 17", CXDI-701C 14" x 17", CXDI-801C 11" x 14", CXDI-710C 14" x 17", CXDI-810C 14" x 11", CXDI-410C 17" x 17"	AeroDR P-51 14" x 17", AeroDR P-52 14" x 17", AeroDR P-61 14" x 17", AeroDR P-71 17" x 17", AeroDR P-81 10" x 12". (Similar range of sizes, all previously cleared)	Met (by equivalence): The new detectors offer a "similar range of sizes" and are all "previously cleared" by FDA. This implies their performance characteristics within those sizes are acceptable.
Pixel Sizes (Detectors)	CANON CXDI (all 125 µm)	AeroDR P-51 175 µm, AeroDR P-52 175 µm, AeroDR P-61 100/200 µm, AeroDR P-71 100/200 µm.	Met (by equivalence): The new pixel sizes are different but are associated with previously cleared detectors, implying their diagnostic utility is acceptable. Specific performance comparison (e.g., to predicate's pixel size) isn't given for diagnostic equivalence, but rather for detector equivalence.
Resolutions (Detectors)	CANON CXDI (various, e.g., CXDI-401C 3320 × 3408 pixels)	AeroDR P-51 1994 × 2430 pixels, AeroDR P-52 1994 × 2430 pixels, AeroDR P-61 3488 × 4256 pixels, AeroDR P-71 4248 × 4248 pixels, AeroDR P-81 2456 × 2968 pixels.	Met (by equivalence): Similar to pixel size, specific resolutions differ but are for previously cleared detectors. Diagnostic equivalence is asserted by the prior clearance of the detectors themselves.
MTF (Detectors)	CANON CXDI (all 0.35 @ 2cy/mm)	AeroDR P-51 0.30 @ 2cy/mm, AeroDR P-52 0.30 @ 2cy/mm, AeroDR P-61 0.30 @ 2cy/mm, AeroDR P-71 0.30 @ 2cy/mm, AeroDR P-81 0.30 @ 2cy/mm.	Met (by equivalence): The new detectors have slightly lower MTF values at 2cy/mm, but these are for previously cleared detectors, implying acceptable image quality for diagnostic use.
DQE (Detectors)	CANON CXDI (all 0.6 @ 0 lp/mm)	AeroDR P-51 0.62 @ 0 lp/mm, AeroDR P-52 0.62 @ 0 lp/mm, AeroDR P-61 0.56 @ 1 lp/mm, AeroDR P-71 0.56 @ 1 lp/mm, AeroDR P-81 0.56 @ 1 lp/mm.	Met (by equivalence): DQE values differ but are for previously cleared detectors, suggesting acceptable performance. Some are higher, some are slightly lower (e.g., P61/P71/P81 at 1 lp/mm vs. predicate at 0 lp/mm). The key is the "previously cleared" status.
Compliance with Standards	N/A (implied by predicate clearance)	IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2014, IEC 60601-1-3:2008+A1:2013, IEC 60601-2-54:2009+A1:2015, IEC 60601-2-28:2010, IEC 60601-1-6:2010 + A1:2013, IEC 62304:2006 + A1:2016.	Met: Device tested and found compliant with these international standards for safety and essential performance.

Summary of the "Study" Proving Acceptance Criteria

The study described is a non-clinical, bench testing-based assessment for demonstrating substantial equivalence rather than a clinical study measuring diagnostic performance outcomes.

The core argument for substantial equivalence is based on:

Identical Indications for Use.
Identical platform (mobile system, generator, collimator, power source).
Replacement of components (detectors and acquisition software) with components that are either:
- Previously FDA cleared (AeroDR detectors, CS-7 software).
- Validated according to FDA guidance (Ultra software).
Compliance with recognized international standards for medical electrical equipment.

Here are the specific details requested:

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. No patient-level test set data is mentioned for testing diagnostic performance. The "test set" consisted of physical devices (systems covering all generator/panel combinations) for bench testing and software for validation.
Data Provenance: Not applicable for a clinical test set. The testing was non-clinical bench testing. The detectors themselves (AeroDR) are stated to have been "previously cleared" by the FDA, implying their performance was established via other submissions, likely including data from various countries consistent with regulatory submissions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. There was no clinical test set requiring expert ground truth establishment for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance."
Effect size of human readers improvement: Not applicable, as no such study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in spirit, for the software component. The new image acquisition software (Ultra) was validated according to the "FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This validation assesses the software's functionality and performance as a standalone component within the system, ensuring it correctly manages workflow, acquires images, and processes them. However, this is software validation, not a standalone diagnostic performance study in the context of an AI algorithm producing diagnostic outputs.

7. The Type of Ground Truth Used

For the overall device: Substantial equivalence to a legally marketed predicate device (K192011 PHOENIX), which itself would have demonstrated safety and effectiveness.
For the components (detectors): Prior FDA clearance of the Konica-Minolta AeroDR panels served as the "ground truth" for their imaging characteristics (MTF, DQE, pixel size, etc.) being diagnostically acceptable.
For the software (Ultra): Validation against specified functional and performance requirements outlined in the FDA software guidance, which serves as the ground truth for software quality and safety.
For the PHOENIX system itself: Compliance with international safety and performance standards (IEC series) served as the ground truth for its electrical, mechanical, and radiation safety.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense of image analysis. It is an imaging acquisition device. The software validation is based on engineering principles and testing, not statistical training on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set for an AI/ML algorithm was used.

Summary

{0}------------------------------------------------

September 14, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Sedecal SA % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K212291

Trade/Device Name: PHOENIX Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB Dated: July 20, 2021 Received: July 22, 2021

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

{1}------------------------------------------------

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,

, for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K212291

Device Name PHOENIX

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary: 510(k) Number K212291

Image /page/3/Picture/1 description: The image is a logo for SEDECAL. The logo is a teal rounded rectangle with white text and a white icon inside. The icon is a person sitting at a desk. The text reads "SEDECAL" in all capital 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 7, 2021 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager

1. Identification of the Device: 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
1. Equivalent legally marketed device: K192011 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
1. Reference devices: We employ these cleared devices without modification: Trade/Device Name: (K151465 and K172793) Konica-Minolta Digital X-ray Panels AeroDR P-51 with CS-7 (K151465) AeroDR P-52 with CS-7 (K151465) AeroDR P-61 with CS-7 (K172793) AeroDR P-71 with CS-7 (K172793) AeroDR P-81 with CS-7 (K172793) Regulation Number: 21 CFR 892. 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB
1. 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.

{4}------------------------------------------------

Not for mammography.

1. Description of the Device: This is a new type of our previous predicate mobile PhoeniX. The predicate PhoeniX mobile is interfaced with Konica – Minolta Digital X-ray panels and CS-7 or Ultra software image acquisition. Phoenix mobile systems will be marketed in the USA by KONICA MINOLTA. Models with the CS-7 Software will be marketed as AeroDR Tran-X Models with the Ultra Software will be marketed as mKDR II. The compatible digital receptor panels are the same for either model. The CS-7 software was cleared under K151465/K172793, while the Ultra software is new. The CS-7 is a DIRECT DIGITIZER used with an image diagnosis device, medical imaging device and image storage device connected via the network. This device digitally processes patient images collected by the medical imaging device to provide image and patient information. By contrast the Ultra-DR software is designed as an exam-based modality image acquisition tool. Ultra-DR software and its accompanying Universal Acquisition Interface (UAI) were developed to be acquisition device independent. Basic Features of the software include Modality Worklist Management (MWM) / Modality Worklist (MWL) support, DICOM Send, CD Burn, DICOM Print, and Exam Procedure Mapping. Ultra Software is designed to increase patient throughput while minimizing data input errors. Ultra is made up of multiple components that increase efficiency while minimizing errors. The main components of Ultra are the Worklist, Acquisition Interface and Configuration Utility. These components combine to create a Stable, Powerful, and Customizable Image capture system. The intuitive graphical user interface is designed to improve Radiology, Technologist accuracy, and image quality. Worklist and Exam screens were developed to allow site specific customizations to seamlessly integrate into existing practice workflows.
  We decided to continue to offer the CS-7 package as a lower cost option for those users who do not need the enhances features of the Ultra software.

Both software packages are of Moderate level of concern. As noted in section 3, above, reference devices: All digital flat panel detectors have received FDA clearance.

Characteristic	Predicate: K192011 PHOENIX	PHOENIX
Indicationsfor Use:	Intended for use by a qualified/traineddoctor or technician on both adult andpediatric subjects for taking diagnosticradiographic exposures of the skull, spinalcolumn, chest, abdomen, extremities, andother body parts. Applications can beperformed with the patient sitting, standing,or lying in the prone or supine position. Notfor mammography.	This is a digital mobile diagnostic x-ray systemintended for use by a qualified/trained doctor ortechnician on both adult and pediatric subjects fortaking diagnostic radiographic exposures of theskull, spinal column, chest, abdomen, extremities,and other body parts. Applications can beperformed with the patient sitting, standing, or lyingin the prone or supine position. Not formammography. (Same, includes device descriptionas requested by FDA)
Configuration	Mobile System with digital x-ray panel andimage acquisition computer	SAME
X-rayGenerator(s)	kW rating: 20 kW, 32 kW, 40 kW and 50 kW.kV range: from 40 kV to 150 kV in 1 kV steps.mA range: from 10 mA to 630 mA / 640 mA /650 mA.	SAME
Collimator	Ralco R108F	Ralco R108F
Characteristic	Predicate: K192011 PHOENIX	PHOENIX
Photos	Image: K192011 PHOENIX	Image: PHOENIX
Meets USPerformanceStandard	YES 21 CFR 1020.30	SAME
PowerSource	Universal power supply, from 100 V~ to 240V~. 1 phase, 1.2 kVA	SAME
Software	Canon control software CXDI-NE	Konica-Minolta control software CS-7 (K151465 orK172793) OR Konica-Minolta control software Ultra.
PanelInterface	Ethernet or Wi-Fi wireless	SAME
DETECTOR TECHNOLOGICAL COMPARISONS
Image areasizes	CANON CXDI-401C 16"x 17"CANON CXDI-701C 14" x 17"CANON CXDI-801C 11" x 14"CANON CXDI-710C 14" x 17"CANON CXDI-810C 14" x 11"CANON CXDI-410C 17" x 17"	AeroDR P-51 14" x 17"AeroDR P-52 14" x 17"AeroDR P-61 14" x 17"AeroDR P-71 17" x 17"AeroDR P-81 10" x 12"Similar range of sizes (All previously cleared)
Pixel sizes	CANON CXDI-401C 125 µmCANON CXDI-701C 125 µmCANON CXDI-801C 125 µmCANON CXDI-710C 125 µmCANON CXDI-810C 125 µmCANON CXDI-410C 125 µm	AeroDR P-51 175 µmAeroDR P-52 175 µmAeroDR P-61 100/200 µmAeroDR P-71 100/200 µm
Characteristic	Predicate: K192011 PHOENIX	PHOENIX
Resolutions	CANON CXDI-401C 3320 × 3408 pixelsCANON CXDI-701C 2800 × 3408 pixelsCANON CXDI-801C 2800 × 2192 pixelsCANON CXDI-710C 2800 × 3408 pixelsCANON CXDI-810C 2800 × 2192 pixelsCANON CXDI-410C 3320 × 3408 pixels	AeroDR P-51 1994 × 2430 pixelsAeroDR P-52 1994 × 2430 pixelsAeroDR P-61 3488 × 4256 pixelsAeroDR P-71 4248 × 4248 pixelsAeroDR P-81 2456 × 2968 pixels
MTF	CANON CXDI-401C 0.35 @ 2cy/mmCANON CXDI-701C 0.35 @ 2cy/mmCANON CXDI-801C 0.35 @ 2cy/mmCANON CXDI-710C 0.35 @ 2cy/mmCANON CXDI-810C 0.35 @ 2cy/mmCANON CXDI-410C 0.35 @ 2cy/mm	AeroDR P-51 0.30 @ 2cy/mmAeroDR P-52 0.30 @ 2cy/mmAeroDR P-61 0.30 @ 2cy/mmAeroDR P-71 0.30 @ 2cy/mmAeroDR P-81 0.30 @ 2cy/mm
DQE	CANON CXDI-401C 0.6 @ 0 lp/mmCANON CXDI-701C 0.6 @ 0 lp/mmCANON CXDI-801C 0.6 @ 0 lp/mmCANON CXDI-710C 0.6 @ 0 lp/mmCANON CXDI-810C 0.6 @ 0 lp/mmCANON CXDI-410C 0.6 @ 0 lp/mm	AeroDR P-51 0.62 @ 0 lp/mmAeroDR P-52 0.62 @ 0 lp/mmAeroDR P-61 0.56 @ 1 lp/mmAeroDR P-71 0.56 @ 1 lp/mmAeroDR P-81 0.56 @ 1 lp/mm
Software	Canon control software CXDI-NE	Konica-Minolta control software CS-7 (K151465 orK172793) OR Konica-Minolta control softwareUltra.
PanelInterface	Ethernet or Wi-Fi wireless	SAME

6) Substantial Equivalence Chart

{5}------------------------------------------------

{6}------------------------------------------------

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 devices are as safe and effective as the predicate devices. Proper system operation is fully verified upon installation. We verified that the modified combination of components worked properly and produced diagnostic quality images as good as our predicate generator/panel combination. Here is a summary of the changes we made to the device: The flat-panel detectors were replaced with the Aero-DR series and the software was changed from the Canon control software CXDI-NE to the Konica-Minolta control software CS-7 (K151465 or K172793) OR Konica-Minolta control software Ultra.

1. Summary of non-clinical testing: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly.
  Firmware was unchanged. New image acquisition software (Utra) was validated according to the FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices .

Because the system uses Wi-Fi and Ethernet, 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 CS-7 digital panel software employed was already reviewed by FDA in K172793.

{7}------------------------------------------------

The PHOENIX Battery Mobile X-Ray Units have been tested to be in compliance with the following International Standards:

a) IEC 60601-1:2005+A1:2012 (Edition 3.1)
b) IEC 60601-1-2:2014 (Edition 4.0)
c) IEC 60601-1-3:2008+A1:2013 (Edition 2.1)
d) IEC 60601-2-54:2009+A1:2015 (Edition 1.1)
e) IEC 60601-2-28:2010 (Edition 3.0)
IEC 60601-1-6:2010 + A1:2013 (Edition 3.1) f)
g) IEC 62304:2006 + A1:2016 (Edition 1.1)
1. Summary of clinical testing: Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance.
1. Conclusion: After analyzing bench and non-clinical tests, it is the conclusion of Sedecal SA. that the modified PHOENIX Digital Diagnostic Mobile X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.