The KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems are intended for use by a qualified/ trained doctor or technician on both adult and pediatic 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 device represents a new combination of already cleared solid state digital x-ray acquisition panels and software with the diagnostic x-ray compnents required to make a complete system. The purchaser may select their digital panel from this list:

Toshiba wireless flat panel detector (FDX-3543RP, FDX-3543RPW, 14 in. x 17 in.) or Toshiba wired flat panel detector (FDX-4343R, 17 in x 17in). (K130883)
Vieworks all series: (FXRD-1717SA/SB, or FXRD-1417SA/SB or FXRD-1417WA/WB. (K130337, Medicatech "New Series.")
PerkinElmer XRpad™ 4336 MED, (K140551).
The purchaser can select either a "C" arm configuration (KrystalRad 1100) or an overhead tube crane configuration (KrystalRad 3000). The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Toshiba (E7252X Series), and the collimator is the Ralco R302A. An IBA kerma meter model 120-131 is supplied.

AI/ML Overview

The provided text describes the KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems. However, it does not contain detailed information regarding the acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods typically found in a clinical study report for AI-powered devices.

This document is a 510(k) premarket notification for a traditional medical device (an X-ray system), not an AI/ML-powered device that requires extensive clinical performance evaluation against specific acceptance criteria. The approval is based on substantial equivalence to a predicate device, meaning it has the same intended use and similar technological characteristics, and that its components have been previously cleared.

Here's a breakdown of the available information based on your request, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical acceptance criteria for a clinical study. The document focuses on demonstrating substantial equivalence to a predicate device.	"The images were found to be of excellent diagnostic quality." (Based on radiologist review)

Missing: Specific quantitative performance metrics (e.g., sensitivity, specificity, AUC) or defined acceptance thresholds for diagnostic accuracy that would be typical for an AI device.

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

Test Set Sample Size: Not specified. The document states "Clinical images were acquired from each panel".
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Number of Experts: One
Qualifications of Experts: "a board certified radiologist."

4. Adjudication Method for the Test Set

Adjudication Method: Implicitly "none," as only one radiologist reviewed the images. There was no consensus or arbitration process mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. This type of study is more common for assessing the impact of AI on human reader performance.
Effect size of improvement with AI vs. without AI: Not applicable, as this is not an AI-powered device.

6. Standalone Performance Study (Algorithm Only)

Was a standalone study done? No. This device is a radiographic system, and its performance is evaluated as an integrated system producing images for human interpretation.

7. Type of Ground Truth Used

Ground Truth Type: Expert opinion/review ("clinical images... reviewed by a board certified radiologist").

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a traditional X-ray system, not an AI/ML model that requires a training set.

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

How Ground Truth Was Established: Not applicable, as there is no training set for an AI/ML model.

Summary of Device and Study Context:

The KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems are conventional X-ray machines. Their FDA clearance (K143257) is based on demonstrating substantial equivalence to an existing legally marketed device (Sedecal Nova FA DR System, K133782). The "study" described is a non-clinical bench testing and review of clinical images to ensure the system functions correctly and produces diagnostically acceptable images. It is not a clinical trial designed to establish specific performance metrics against a medical condition, nor does it involve an AI algorithm with training and test sets. The focus is on the safety and effectiveness of the hardware and integrated software for image acquisition, primarily through demonstrating that its components (cleared digital panels, generator, collimator) work together to produce images of "excellent diagnostic quality" as judged by a single radiologist.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a wing-like shape above them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 6, 2015

MedicaTech USA % Daniel Kamm, P. E. Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K143257

Trade/Device Name: KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MOB Dated: January 13, 2015 Received: January 15, 2015

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting 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) K143257

Device Name

KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(K) Summary, 510(k) K143257 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: August 21, 2014

1. Identification of the Device: Proprietary-Trade Name: KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems Classification Name: Stationary X-Ray System, Product codes KPR and MQB Common/Usual Name: Digital Diagnositc X-Ray System Device Class: II per regulation 21CFR892.1680

2. Equivalent legally marketed device: K133782, Sedecal Nova FA DR System, Sedecal SA.

1. Indications for Use The KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems are 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 and software with the diagnostic x-ray compnents required to make a complete system. The purchaser may select their digital panel from this list:
Toshiba wireless flat panel detector (FDX-3543RP, FDX-3543RPW, 14 in. x 17 in.) or Toshiba wired flat panel detector (FDX-4343R, 17 in x 17in). (K130883)
Vieworks all series: (FXRD-1717SA/SB, or FXRD-1417SA/SB or FXRD-1417WA/WB. (K130337, Medicatech "New Series.")
PerkinElmer XRpad™ 4336 MED, (K140551).

The purchaser can select either a "C" arm configuration (KrystalRad 1100) or an overhead tube crane configuration (KrystalRad 3000). Please see the photos below. The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Toshiba (E7252X Series), and the collimator is the Ralco R302A. An IBA kerma meter model 120-131 is supplied. 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. The generator complies with IEC 60601-2-54.

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 and software.
1. Substantial Equivalence Chart: Please see the next page.

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Characteristic	Sedecal Nova FA K133782	KrystalRad 1100 and KrystalRad 3000
Intended Use:	Sedlecal "NOVA FA DR System" is intendedfor use by a qualified/trained doctor ortechnician on both adult and pediatricsubjects for taking diagnostic radiographicexposures of the skull, 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.	KrystalRad 1100 and KrystalRad 3000 are intendedfor use by a qualified/trained doctor or technicianon both adult and pediatric subjects for takingdiagnostic radiographic exposures of the skull,spinal column, chest. abdomen, extremities, andother body parts. Applications can be performedwith the patient sitting, standing, or lying in theprone or supine position. Not for mammography.
Configuration ofDigital Panels	Battery or AC operated wireless IEEE 802.11nor Wired Ethernet	SAME
Digital PanelModels and theirclearancenumbers	CXDI Canon Detector 401C/401C Compact(K103591)CXDI Canon Detector 55C (K091436)CXDI Canon Detector 501C (K111682)	Vieworks/Medicatech FXRD-1717SA/SB, FXRD-1417SA/SB and FXRD-1417WA/WB (K130337)Toshiba: FDX4343R/RPW, FDX3543RP andFDX3543RPW (Del Medical: K140825; O&R:K131121; Sedecal: K130883)PerkinElmer: XRpad 4336 MED (K140551)
Image acquisitionpanelspecifications	3,320 x 3,408 125 μm (401C) or2,208 x 2,688 pixels 160 μm (55C)2,800 x 3,408 Pixels 125 μm (501C)	FXRD-1717SA/SB: 3,072 x 3,072, 140μmFXRD-1417SA/SB: 2560 x 3072, 140μmFXRD-1417WA/WB: 2560 x 3072, 140μmFDX4343R/RPW: 3008×3072, 143 μmFDX3543RP: 2448×2984, 143 μmFDX3543RPW: 2466×3040, 140μmXRpad 4336 MED: 3556×4320, 100 μm
DICOM	DICOM 3	DICOM 3
WiFi WirelessIEEE802.11n(All others areEthernetTethered.	Not applicable, but compatible with all Canonpanels, including wireless.	Vieworks FXRD-1417WA/WBToshiba FDX3543RPWPerkinElmer XRpad 4336 MED
Image acquisitionsoftware	CANON cleared in K111682	CrystalRad as cleared in K130377
Power Source	AC Line, various voltages available	SAME
Photo	Image: Sedecal Nova FA K133782	Image: Krystalrad 3000
Characteristic	Sedecal Nova FA K133782	KrystalRad 1100 and KrystalRad 3000
Alternateconfiguration	Sedecal X-Plus LP Plus, K090238Image: Sedecal X-Plus LP Plus, K090238	KrystalRad 1100Image: KrystalRad 1100
Generator	Sedecal SHF	CPI CMP 200DR
Collimator	Ralco R225A	Ralco R301A
PerformanceStandard	FDA 21CFR1020.30-31	SAME
Electrical safety	Electrical Safety per IEC-60601. UL listed	SAME

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1. Summary of non-clinical testing: We performed integration testing. 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. 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.) All of the panels comply with NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set. Successful testing according to 60601-2-54 standard had been performed on the CPI generator.
Summary of clinical testing: Clinical images were acquired from each panel and reviewed by 8. a board certified radiologist. 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 "KrystalRad 1100 and KrystalRad 3000" are as safe and effective as the predicate device, have few technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device. "Technological differences from the predicate device include different detectors, some with wireless functionality, a different system generator, and collimator. Although the components differ from the primary predicate device. the detectors and other components have been cleared as part of other 510(k) submissions as noted in this 510(k) Summary. Integration testing, including acquisition of phantom images, demonstrated that the hardware and software components work properly together.

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.