The MasteRad MX30 is 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.

Device Description

This device represents a new combination of already cleared solid state digital x-ray acquisition panels (plus one NEW panel) and software with the diagnostic x-ray compnents required to make a complete system. The purchaser may select their digital panel from this list: Varex PaxScan 2530Wv4, Varex PaxScan 4336Wv4, Varex PaxScan 4343R, Varex PaxScan 4343RC, Varex XRpad 4343F, Varex XRpad 3025, Varex XRpad 4336, Toshiba* FDXA4343R. As compared to our predicate system, the tube stand is floor mounted instead of ceiling mounted. The collimator is different. Instead of the Ralco collimator, a Collimare model is supplied. The purchaser selects one of the following FDA certified models: CML-150-0001-C; CTL-150-0001-C; CML-125-0001-C. The x-ray tube and the high voltage generator remains the same as our predicate. The x-ray tube is a Toshiba model and the generator is the CPI CMP 200DR. The image acquisition software is a newer version of our Voyance software originally cleared in K130377.

AI/ML Overview

The MasteRad MX30 is an X-ray system, and the provided text describes its substantial equivalence to a predicate device (K143257). The acceptance criteria and supporting studies are based on demonstrating that the new device, particularly a new digital X-ray receptor panel, maintains diagnostic quality and safety.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly tied to demonstrating that the new Toshiba FDXA4343R digital panel (and the overall MasteRad MX30 system) performs at least as well as, or equivalently to, the predicate device and the previously cleared Toshiba FDX4343R panel. The primary performance criterion is diagnostic quality of images.

Acceptance Criteria Category	Specific Metric (Implicit)	Acceptance Standard (Implicit, based on predicate/previous panel)	Reported Device Performance (Toshiba FDXA4343R)
Image Quality	Limiting Resolution	3.5 Lp/mm typ (from predicate's Toshiba FDX4343R)	3.7 Lp/mm Max. (Slightly better)
	MTF (2.0 Lp/mm, 70 kVp, 1x1)	36 % Typ (from predicate's Toshiba FDX4343R)	50 % typ (Slightly better)
	DQE (0), Quantum-Limited	> 70 % (from predicate's Toshiba FDX4343R)	> 56 % (Typ.) (Not a meaningful difference, found to be of diagnostic quality)
	A/D Conversion	14 bit (from predicate's Toshiba FDX4343R)	16 bit (Slightly better)
Functional Equivalence	Cycle Time	Shot to Shot 6 sec (from predicate's Toshiba FDX4343R)	Shot to Shot 6 sec (No difference)
Clinical Diagnostic Value	Diagnostic image quality	Images found to be of diagnostic quality (for predicate's panel)	Images found to be of excellent diagnostic quality
System Safety	Compliance with standards	US Performance Standards, UL 60601-1, IEC 60601-1, IEC 60601-1-2 (for predicate)	Conforms to US Performance Standards and hardware UL Listed to US Standards for safety for medical devices (UL 60601-1). Complies with IEC 60601-1 and IEC 60601-1-2.
Software Functionality	Software Validation & Risk Management	Demonstrated for predicate/previous software versions.	Software validation and risk management performed for updated software version. Complies with NEMA PS 3.1 - 3.18 (2009) DICOM.

2. Sample sized used for the test set and the data provenance

Sample Size: The document does not specify a numerical sample size for the clinical images beyond stating "Clinical images were acquired from the new Toshiba panel." It implies a sufficient number were obtained for review, but no specific count is given.
Data Provenance: The document does not explicitly state the country of origin. It indicates the images were "acquired from the new Toshiba panel" for the purpose of this submission, which suggests a prospective acquisition for evaluation, specifically for a new panel not previously cleared by the FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: One expert.
Qualifications: "A board certified radiologist." No specific years of experience are mentioned.

4. Adjudication method for the test set

Adjudication Method: Not applicable/None explicitly stated as an adjudication method. The evaluation was performed by a single board-certified radiologist who "reviewed" the images and "found them to be of excellent diagnostic quality." There is no mention of multiple reviewers or a consensus process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.
AI Improvement Effect Size: Not applicable. This submission is for an X-ray system and its digital detector, not an AI-powered diagnostic tool for interpretation.

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

Standalone Performance: Not applicable. This device is an X-ray acquisition system, not a standalone algorithm. The "performance" described relates to the imaging capabilities of the hardware component (the digital detector) rather than an interpretive algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Ground Truth Type: Expert opinion/evaluation. The ground truth for image quality was established by a single board-certified radiologist's assessment of "diagnostic quality." This is based on the expert's interpretation of whether the images are suitable for clinical diagnosis.

8. The sample size for the training set

Training Set Sample Size: Not applicable. The document describes the validation of a hardware system and its updated software, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Training Set Ground Truth Establishment: Not applicable, as there was no training set for a machine learning model.

Summary

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April 25, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an eagle-like figure, representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

MedicaTech USA % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K190601

Trade/Device Name: MasteRad MX30 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MOB Dated: March 29, 2019 Received: April 2, 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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara
For

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

Enclosure

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Indications for Use

510(k) Number (if known) K190601

Device Name MasteRad MX30

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, 510(k) K190601

Submitter: MedicaTech USA 50 Maxwell Irvine , CA , 92618 Toll Free : +1 800 817 5030 Phone : +1 949 679 2881 FAX : +1 949 679 2882 Registration Number 3004989804 Contact: George Makar, Predsident Date Prepared: January 23, 2019

1. Identification of the Device:

Trade/Device Names: MasteRad MX30 Regulation Number: 21CFR892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: KPR and MQB Common/Usual Name: Stationary Digital Diagnostic X-Ray System

Equivalent legally marketed device: K143257 Trade/Device Name: KrystalRad 1100 and KrystalRad 3000 Manufacturer: MedicaTech USA Regulation Number: 21CFR892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: KPR and MQB Common/Usual Name: Stationary Digital Diagnostic X-Ray System

1. Indications for Use The MasteRad MX30 is 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.
1. Description of the Device: This device represents a new combination of already cleared solid state digital x-ray acquisition panels (plus one NEW panel) and software with the diagnostic x-ray compnents required to make a complete system. The purchaser may select their digital panel from this list:.

Manufacturer Model Number	MedicaTech Model Number	510(k) Number
Varex PaxScan 2530Wv4	Master X CW25	K161459
Varex PaxScan 4336Wv4	Master X CW36	K161459
Varex PaxScan 4343R	Master X FC43	K172951
Varex PaxScan 4343RC	Master X PT43	K172951
Varex XRpad 4343F	Master X HDF43	K142698
Varex XRpad 3025	Master X WPH25	K161942
Varex XRpad 4336	Master X WHD36	K161966
Toshiba* FDXA4343R	Master X FA43	New

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As compared to our predicate system, the tube stand is floor mounted instead of ceiling mounted. The collimator is different. Instead of the Ralco collimator, a Collimare model is supplied. The purchaser selects one of the following FDA certified models: CML-150-0001-C; CTL-150-0001-C; CML-125-0001-C. The x-ray tube and the high voltage generator remains the same as our predicate. The x-ray tube is a Toshiba model and the generator is the CPI CMP 200DR. The image acquisition software is a newer version of our Voyance software originally cleared in K130377

The system complies with the CDRH Radiological Health performance standard in the Code of Federal Regulations, as well as the voluntary IEC standards IEC 60601-1 and IEC 60601-1-2. *Toshiba panel division has recently been purchased by Canon.

1. Safety and Effectiveness, comparison to predicate device. This combination device has the same indications for use and very similar technological characteristics as the predicate device, and employs already 510(k) cleared digital panels (except for the Toshiba unit) and software.

CharacteristiC	K143257 KrystalRad 1100 andKrystalRad 3000 Digital StationaryRadiographic Systems	MastRad MX30
Indicationsfor Use:	The KrystalRad Systems are intended foruse by a qualified/trained doctor ortechnician on both adult and pediatricsubjects for taking diagnosticradiographic exposures of the skull,spinal column, chest. abdomen,extremities, and other body parts.Applications can be performed with thepatient sitting, standing, or lying in theprone or supine position. Not formammography.	MasteRad MX30 is intended for use by aqualified/trained doctor or technician onboth adult and pediatric subjects for takingdiagnostic radiographic exposures of theskull, spinal column, chest. abdomen,extremities, and other body parts.Applications can be performed with thepatient sitting, standing, or lying in the proneor supine position. Not for mammography.SAME
Configurationof DigitalPanels	Battery or AC operated wireless IEEE802.11n or Wired Ethernet	Battery or AC operated wireless IEEE 802.11nor Wired Ethernet (depending on the modelchosen) SAME
Digital PanelModels	Vieworks FXRD-1717SA/SB, orVieworks FXRD-1417SA/SB orVieworks FXRD-1417WA/WB orToshiba: FDX4343R/RPW orToshiba FDX3543RP/RPW orVarex XRpad 4336	Varex PaxScan 2530Wv4 orVarex PaxScan 4336Wv4 orVarex PaxScan 4343R orVarex PaxScan 4343RC orVarex XRpad 4343F orVarex XRpad 3025 orVarex XRpad 4336 orToshiba (Now Canon) FDXA4343R
DICOM	DICOM 3	SAME

Substantial Equivalence Chart: 6.

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Characteristic	K143257 KrystalRad 1100 andKrystalRad 3000 Digital StationaryRadiographic Systems	MastRad MX30
Imageacquisitionsoftware	Voyance	Voyance. Updated.
Power Source	AC Line, various voltages available	SAME
Photo	Image: Krystalrad 3000	Image: MasteRad MX30Difference: Floor Mount instead of CeilingMount.
Generator	CPI CMP 200DR	SAME
X-Ray Tube	Toshiba	SAME
Collimator	Ralco R301A	Collimare LLC, one of the following FDAcertified models: CML-150-0001-C,CTL-150-0001-C, CML-125-0001-C

A new digital x-ray receptor panel not previously cleared by FDA is offered. The predecessor to this panel was cleared in K130883. The characteristics are compared in the table below. The images were evaluated by a Board Certified Radiologist, and found to be of diagnostic quality.

Characteristic	Sedecal Digital Radiogniphic UpgradeModel SDRU-T K130883 (Toshiba ModelFDX4343R)	Toshiba Model FDXA4343R (One of theavailable models for MasteRad.)
Image Format
X-rayConversionLayer	Cesium lodide (Csl) with AmorphousSilicon (a-Si) Photodiode	SAME
Active Area	430(H)×439(V)mm (16.9×17.3 inch)	426 (H)×425 (V) mm (16.8×16.7 inch)(Not a meaningful difference)
Pixel Matrix	3008(H)×3072(V)	3040 (H)×3036 (V) (Not a meaningfuldifference)
Pixel Pitch	143 $ \mu $ m	140 $ \mu $ m (Not a meaningful difference)

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Characteristic	Sedecal Digital Radiogniphic UpgradeModel SDRU-T K130883 (Toshiba ModelFDX4343R)	Toshiba Model FDXA4343R (One of theavailable models for MasteRad.
Cycle Time	Shot to Shot 6sec	Shot to Shot 6sec No difference
Performance
LimitingResolution	3.5 Lp/mm typ	3.7 Lp/mm Max. Slightly better
MTF (2.0Lp/mm, 70kVp, 1x1)	36 % Typ	50 % typ Slightly better
DQE (0),Quantum -Limited	> 70 %	> 56 % (Typ.) (Not a meaningfuldifference. Images found to be ofdiagnostic quality, however)
A/DConversion	14 bit	16 bit Slightly better

1. Summary of non-clinical testing: We performed software validation and risk management for the updated software version. The following FDA guidances were employed in those activities: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The software comlies with NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine We revised our labeling in light of the FDA guidance: Pediatric Information for X-ray (DICOM) Set. Imaqinq Device Premarket Notifications. We performed integration testing to show that each panel performed correctly in the full system. The device conforms to US Performance Standards and the hardware is UL Listed to US Standards for safety for medical devices (UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety standard by Underwriters Laboratories, 04/25/2003.) There is one new digital receptor panel, and we were provided test information per Guidance for the Submission of 510(k)s for Solid State X-ray Imaginq Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016 The software comlies with NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set. The results of a review of bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device
1. Summary of clinical testing: Clinical images are not required for the previously cleared panels, but the new Toshiba panel has not previously received FDA clearance. Clinical images were acquired from the new Toshiba panel and reviewed by a board certified radiologist, as recommended in the FDA document: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices The images were found to be of excellent diagnostic quality.
1. Conclusion: After analyzing software integration validation, safety testing data, and clinical images, it is the conclusion of Medicatech USA that the "MedRad" system is as safe and effective as the predicate device, has insignificant technological differences, and has identical 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.