The purpose of Acuity is to acquire, store, communicate, display and process medical X-ray images. These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, angiography, interventional, or fluoroscopy use.

Device Description

RadmediX Acuity combines components into a complete stationary x-ray system, including software, tube stands, tube heads, collimators, generators, tables, and digital radiography panels.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance:

The document describes the Acuity SDR Standard, Acuity SDR Plus, and Acuity FDR Standard as stationary x-ray systems. The core claim for substantial equivalence is that the device performs the same functions using the same technological methods as the predicate device (Visaris Vision®) to produce diagnostic x-ray images.

Feature / Criterion	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Acuity Systems)
Indications for Use	Acquisition, storage, communication, display, and processing of medical X-ray images for diagnostic X-rays on adult and pediatric subjects. Not for mammography, angiography, interventional, or fluoroscopy use.	Identical to predicate.
Wall Stand Functionality	Motorized vertical movable wall stand, tiltable tray.	"SAME" – Equivalent Functionality.
Table Functionality	Free-floating and height-adjustable, maximum patient weight 660 lbs., working table height 20-5/16 inch to 37-5/8 inch.	"SAME" – Equivalent Functionality.
X-ray Tube Specifications	150 kVp 0.6/1.2mm focal spots (Toshiba).	"SAME" – Equivalent Functionality.
Collimator Certification	All CFR Certified. (510(k) exempt)	Collimaire collimators, all CFR Certified. (510(k) exempt) – Equivalent Functionality.
X-ray Generator Types and Certification	Various HF Models (Claymount up to 63 kW, CPI 32kW to 100kW, EMD 45 kW to 80 kW, POSKOM 32 kW to 50 kW, Sedecal 40, 50, 65, or 80 kW), all CFR Certified.	Various HF Models (Summit 40 to 50 kW, CPI up to 80 kW), all CFR Certified. (510(k) exempt) – Equivalent Functionality.
Wireless Detector Capability	Uses FDA cleared 14" x 17" detectors and software (e.g., Pixium 3543 EZ C).	Optional enclosure for 14" x 17" fixed and removable FDA cleared detectors and software. – Equivalent Functionality.
Fixed Detector Capability	Uses FDA cleared 17"x17" detectors and software (e.g., Pixium 4343RC).	Uses FDA cleared 17"x17" detectors and software. – Equivalent Functionality. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compatibility with Conventional Film/CR Cassettes	Comes with FDA cleared digital x-ray panels, but conventional film and CR cassettes can still be used.	"SAME" – Similar Functionality. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Operator Console Interface	GUI-based.	"SAME" – Similar Functionality. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Acquisition Software	FDA cleared digital x-ray acquisition software (e.g., Visaris Avanse, K150725).	Customer selects AccuVueMED (K152172) or AccuVue (K141440). Only cleared software is supplied. – Equivalent Functionality. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Power Source	AC LINE, single or three phase depending on the generator.	"SAME" – SAME. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance with Standards	IEC 60601-1:2005 (Basic Safety and Essential Performance), IEC 60601-1-2:2014 (Electromagnetic Disturbances), IEC 60601-2-54 Ed 1.0 (X-Ray Equipment for Radiography and Radioscopy), NEMA PS 3.1 - 3.20 (2011) DICOM Set, 21CFR1020 (Electronic Products; Performance Standard for Diagnostic X-Ray Systems). Component certification by manufacturers.	"SAME" – Generators are UL Listed. Components certified by manufacturers. Software used unmodified from previous FDA clearances. – SAME. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Image Quality (Clinical Acceptability)	Produce images of high quality and contrast, clinically acceptable for diagnostic x-rays across various anatomical regions.	A constructed and field-tested complete system (AcuitySDR with specific components) acquired DICOM images from all major body structures, all images were of high quality and contrast and clinically acceptable. Each new configuration undergoes a digital image integration protocol and a total system validation protocol prior to ensure the configuration works as intended. "The flat-panel detectors used with the x-ray system Acuity present comparable or better performance than the predicate detectors."
Cybersecurity	Managed as per FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff October 2014".	Updated internal standard operating procedures and added cybersecurity precautions to software users' manuals. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Pediatric Considerations in User Manuals	Included in user manuals.	Generator User Manuals have been updated to add Pediatric Considerations. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Study Information:

Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a numerical sample size of clinical cases for a formal clinical trial. Instead, the non-clinical testing involved acquiring DICOM images from "all major body structures" using one AcuitySDR system configuration.
- Data Provenance: The document does not specify the country of origin for the image acquisition or whether it was retrospective or prospective. It was a "field tested" system, implying real-world or simulated real-world scenarios.
Number of Experts and Qualifications (for Ground Truth):
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified, beyond the statement that images were generated for "diagnostic x-rays" and assessed as "clinically acceptable." This implies evaluation by trained personnel (e.g., radiologic technologists, radiologists), but their specific qualifications or number are not detailed.
Adjudication Method:
- No formal adjudication method is described. The assessment of image quality was based on whether images were "of high quality and contrast and clinically acceptable."
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was performed or described. The submission focuses on demonstrating substantial equivalence through technical characteristics and non-clinical image quality assessment, not on human reader performance improvement with or without AI assistance.
Standalone Performance Study (Algorithm Only):
- Yes, a standalone study (non-clinical testing) was performed. The algorithm (software) alongside the hardware components was tested to acquire and process images. The output (DICOM images) was then evaluated for inherent quality and acceptability. The assessment "all images were of high quality and contrast and clinically acceptable" refers to the output of the integrated system.
Type of Ground Truth Used:
- Expert Consensus / Clinical Acceptability: The ground truth for image quality was established through subjective expert assessment of "high quality and contrast and clinically acceptable." It does not mention pathology or outcomes data.
Training Set Sample Size:
- Not applicable. This device is an X-ray system, not an AI/ML algorithm that requires a training set in the typical sense for image interpretation or diagnosis. The "software" components mentioned (AccuVueMED, AccuVue) are image acquisition and processing software, which are generally deterministic and not "trained" on data in the way a diagnostic AI would be. They are "previously cleared software supplied with the system."
How Ground Truth for Training Set Was Established:
- Not applicable, as there is no specific "training set" for an AI/ML algorithm in this submission. The software components were previously cleared by the FDA, implying their performance was established through other means at the time of their original clearance (K152172 and K141440).

Summary

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January 2, 2020

Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.

Radmedix LLC % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114

Re: K193360

Trade/Device Name: Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: December 2, 2019 Received: December 4, 2019

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 avare 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 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-reporting

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combination-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 medical devices and radiation-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

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Indications for Use

510(k) Number (if known) K193360

Device Name

Acuity: AcuitySDR Standard; AcuitySDR Plus; AcuityFDR Standard

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)

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510(k) Summary K193360

Image /page/3/Picture/1 description: The image shows a logo with the text "RadmediX". The "R" and "X" are in blue, while the "admedi" is in a lighter gray color. The letters are overlapping each other, creating a layered effect. The logo appears to be for a company or organization named RadmediX.

RadmediX, LLC 2510 Lance Rd. Dayton, OH 45409 Tel 844 723 6334 Registration Number: 3009134655 Radmedix Acuity (AcuitySDR Standard; AcuitySDR Plus; AcuityFDR Standard)

1. Administrative Information

Reason for Submission: 510(k) Notification for RadmediX AcuitySDR Standard; AcuitySDR Plus; AcuityFDR Standard), new combination of Exempt and Cleared devices

Submitter:
Submission contact person:	Gabriel Issa, Director of Equipment
Contact telephone:	844 723 6334
Contact e-mail:	gabe@radmedix.com
Date prepared:	December 17, 2019
Identification:
Classification Name:	AcuitySDR Standard; AcuitySDR Plus; AcuityFDR Standard
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1680
Device Class:	Class II
Product Code:	KPR, Secondary: MQB
Substantially equivalent device:
Trade Name:	Visaris Vision® (Vision C, Vision U. Vision V, Vision X)
Manufacturer:	Visaris DOO.
510(k) #:	K160620
Classification Name:	Stationary X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1680
Device Class:	Class II
Product Code:	KPR, Secondary: MQB

2. Device description: 21 CFR 807 92 (a) (4)

RadmediX Acuity combines components into a complete stationary x-ray system, including software, tube stands, tube heads, collimators, generators, tables, and digital radiography panels.

21CFR §892.1680 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

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of device may include signal analysis and display equipment supports, comports, component parts, and accessories.

Radmedix combines components from various manufacturers into a complete stationary x-ray system. The major component combining these into a complete solution is the tube stands are made to carry the weight of the tube head, collimator, and digital X-ray panels. These tube stands may also have supporting devices such as wall stands, tables, stitching stands, and chairs. These supporting devices allow for imaging in standing, sitting, and laying positions. The Radmedix Acuity tube stands with supporting devices make a stationary x-ray system allowing for ease of use for the technologist and provides rapid patient care. Similar to the predicate our stationary x-ray system employs a tube stand that is a generic type of device and can use various brands of tube heads, collimators, generators, and digital radiography panels all meeting the cited performance standard.

AcuitySDRStandard;	Straight Arm System Stand:"SYFM SU-2000"	Image: Straight Arm System Stand
AcuitySDRPlus;	Straight Arm System Stand withTouchscreen "SYFM SU-2100",	Image: Straight Arm System Stand with Touchscreen

Radmedix Acuity models:

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Image /page/5/Picture/0 description: The image shows the AcuityFDR Standard Floor Mounted System "SST-4000". The system includes a floor-mounted stand with a detector and a table. The table is designed to support patients during X-ray imaging.

Radmedix provides previously cleared digital x-ray detectors. The panel enclosures in our systems are designed around the EVS 3643, EVS 3643G panel cleared under (K151942), and the EVS 4343G panel cleared under (K142475). Those digital x-ray panels are 14″ x 17″ standard cassette sized digital x-ray detectors. The panel enclosure can support other similarly sized detectors.

The previously cleared software supplied with the system is AccuVueMED (Relabeled version of K152172). This medical software communicates with the digital x-ray detector and allows acquisition and processing of x-ray images. This software complies with DICOM standards and can transmit and receive data with a PACS system. The software is configurable to acquire images from various digital radiography panels. The other previously cleared software optionally available package is AccuVue, (Relabeled version of K141440.) The flat-panel detectors used with the x-ray system Acuity present comparable or better performance than the predicate detectors.

DRTECHCORPORATION	EVS 3643, EVS 3643G	K162552
DRTECHCORPORATION	EVS 3643	K151942
DRTECHCORPORATION	EVS 4343	K142475
DRTECHCORPORATION	EVS 4343, EVS 4343G	K162555
DRTECHCORPORATION	EVS 2430W, EVS 2430GW	K171137
DRTECHCORPORATION	EVS 4343W, EVS4343WG, EVS 3643W, EVS 3643WG, EVS4343WP, EVS 3643WP	K193017

The default software AccuVueMED (K152172) is the software normally paired with the default digital panels from DRTECH CORPORATION. Here is a compatibility table:

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For other optionally available panels the customer would receive the AccuVue software, a relabeled version of K141440. See the table below.

Optionally available panels
LG Electronics	17HK700G-W	K180332
LG Electronics	14HK701G-W	K182348
LG Electronics	17HK701G-W	K183286
IRay	Mars1717XF-CSI Wireless	K183713
IRay	Mars1717XF-GSI Wireless	K183422
IRay	Mars1417XF-GSI Wireless	K182550
IRay	Mars1417XF-CSI Wireless	K182551
IRay	Mars1417V-PSI Wireless	K161730

Available Generators

Summit Models L300, L500, L550, 00210, 02968, 03900, 03901 (40 or 50 kW) or CPI Model CMP 200 DR (40, 50, 65, or 80 kW)

Collimators

Collimare, LLC CML-150-0001-C, 150kVp Certified Manual Collimator or CML-125-0001-C, 125kVp Certified Manual Collimator

X-Ray Tube Housing: Toshiba

The purchaser selects one of these: Toshiba E7239FX tube Toshiba E7242FX tube Toshiba E7252FX tube

3. Indications for Use: 21 CFR 807 92 (a) (5)

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4. Technological characteristics: 21 CFR 807 92 (a) (6) Comparison Table

ComparableProperties	Predicate Device: K160620 VisarisVision® (Vision C, Vision U, Vision V,Vision X)	Acuity (Three models) AcuitySDRStandard; AcuitySDR Plus;AcuityFDR Standard	ComparisonResults
Indicationsfor use	The purpose of Visaris Vision® is toacquire, store, communicate, displayand process medical X-ray images.These radiographic systems areintended for use by aqualified/trained physician ortechnician on both adult andpediatric subjects for takingdiagnostic x-rays. Not formammography, angiography,interventional, or fluoroscopy use.	The purpose of Acuity is to acquire,store, communicate, display andprocess medical X-ray images.These radiographic systems areintended for use by aqualified/trained physician ortechnician on both adult andpediatric subjects for takingdiagnostic x-rays. Not formammography, angiography,interventional, or fluoroscopy use.	Identical
Wall stand	Motorized vertical movable wallstand, tiltable tray.	SAME	EquivalentFunctionality
Table	Free-floating and height-adjustable,maximum patient weight 660 lbs.,working table height 20-5/16 inch to37-5/8 inch.	SAME.	EquivalentFunctionality
X-ray tube	150 kVp 0.6/1.2mm focal spots.Toshiba	SAME	EquivalentFunctionality
Collimator	Ralco Claymount, X-Alliance, or (AllCFR Certified) (510(k) exempt)	Collimaire collimators, all CFRCertified (510(k) exempt)	EquivalentFunctionality
X-rayGenerator	Various Models available: (All HF)Claymount, (up to 63 kW)CPI, (32kW to 100kW)EMD, (45 kW, to 80 kW)POSKOM (32 kW to 50 kW)Sedecal (40, 50, 65, or 80 kW)(All CFR Certified)	Various Models available: (All HF)(All CFR Certified):Summit models from 40 to 50 kWCPI generators up to 80 kW areavailable optionally. (510(k)exempt)	EquivalentFunctionality
Wirelessdetector	14" x 17" Uses FDA cleared detectorand software. Pixium 3543 EZ C(Other previously cleared modelsavailable, see table above)	Optional enclosure allows for 14" x17" fixed and removable FDAcleared detectors and software.	EquivalentFunctionality
Fixeddetector	17"x17". Uses FDA cleared detectorand software. Pixium 4343RC (Otherpreviously cleared models available)	17"x17". Uses FDA cleareddetector and software.	EquivalentFunctionality
Conventionalfilm/screensystems or CRcassettes	Comes with FDA cleared digital x-raypanels.Conventional film and CRcassettes can still be used. .	SAME	SimilarFunctionality
ComparableProperties	Predicate Device: K160620 VisarisVision ® (Vision C, Vision U, Vision V,Vision X)	Acuity (Three models) AcuitySDRStandard; AcuitySDR Plus;AcuityFDR Standard	ComparisonResults
Operatorconsole	GUI-based	SAME	SimilarFunctionality
AcquisitionSoftware	Visaris Avanse, K150725,	Customer Selects:AccuVueMED (K152172)AccuVue (K141440)	EquivalentFunctionalityOnly clearedsoftware issupplied.
Photos	Visaris Vision X	Radmedix AcuitySDR	Similarity isobvious.
Power Source	AC LINE, single or three phasedepending on the generator	SAME	SAME.
Standards	60601-1:2005; 60601-1-2:201460601-2-54 Edition 1.0; PS 3.1 - 3.20(2011) 21CFR1020	SAMEGenerators are UL Listed	SAME

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5. Non clinical testing

Testing was performed successfully according to the following standards:

FDARecognitionNumber	StandardDevelopingOrganization	Standard DesignationNumber And Date	Title Of Standard
19-5	IEC	60601-1:2005	Medical Electrical Equipment Part 1: General Requirements ForBasic Safety And Essential Performance (IEC 60601 1:2005, MOD)
19-1	IEC	60601-1-2:2014	Medical Electrical Equipment Part 12: General Requirements ForBasic Safety And Essential Performance Collateral Standard:Electromagnetic Disturbances Requirements And Tests
12-274	IEC	60601-2-54 Edition 1.0	Medical Electrical Equipment Part 2-54: Particular RequirementsFor The Basic Safety And Essential Performance Of X- RayEquipment For Radiography And Radioscopy [Including: TechnicalCorrigendum 1 (2010), Technical Corrigendum 2 (2011)]
12-238	NEMA	PS 3.1 - 3.20 (2011)	NEMA Digital Imaging and Communications in Medicine (DICOM)Set
N/A	FDA	21CFR1020	Electronic Products; Performance Standard for Diagnostic X-RaySystems and Their Major Components

All of the components subject to the CDRH performance standard are certified to comply with the standard by their respective manufacturers. We do not supply any non-certified components. All X-ray components (generators, tubes, collimators, and applicable accessories) carry an NRTL certification label (UL, ETL, etc.). The software employed was used unmodified from clearances obtained from FDA. Since

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multiple configurations are available, our service engineers fully test each new system upon installation at the customer site. In recognition of possible cybersecurity threats to the software, we consulted this guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff October 2014. As a result, we updated our own internal standard operating procedures and added cybersecurity precautions to the software users' manuals. Generator User Manuals have been updated to add Pediatric Considerations.

We also constructed and field tested a complete system and acquired DICOM images from all major body structures, including abdomen, ankle, calcaneus, c-spine ap and c-spine lateral, elbow, foot, knee, hand, lspine ap and I-spine lateral, shoulder, chest, and skull. All images were of high quality and contrast and clinically acceptable. This testing was performed on an AcuitySDR system equipped with the following components: Stand, SYFM SU2100, a Toshiba E7242FXX tube head, a Collimaire CML-125, a Summit L550-31 generator, and a DRTech EVS 4343G digital receptor panel. Each new configuration undergoes a digital image integration protocol and a total system validation protocol prior to make sure that the configuration works as intended.

6. Clinical testing

Not required for a determination of substantial equivalence.

7. Substantial Equivalence Discussion.

The RadmediX Acuity performs the same functions using the same technological methods to produce diagnostic x-ray images. In all material aspects, the Visaris and the RadmediX systems are substantially equivalent to each other. The flat-panel detectors used with the x-ray system Acuity present comparable or better performance than the predicate detectors.

8. Substantial Equivalence Conclusion:

After analyzing bench test results, risk analysis, and clinical evaluation, it is the conclusion of RadmediX LLC that the RadmediX 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

§ 892.1680 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.