The KrystalRad 560 (FLAATZ 560) Digital X-Ray System is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammography applications).

Device Description

The KrystalRad 560 (FLAATZ 560) System is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire X-ray film or an image plate as an image capture medium. The KrystalRad 560 (FLAATZ 560) device differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector Panel is used to capture the image in electronic form.

Once the system captures a radiographic image and subsequently displaying and storing an image, radiologists or physicians can adjust the image electronically to optimize the view of the desired anatomy at a work station. The system enables a user to duplicate images without having to take additional exposures so that the user can easily transmit a duplicate to the second physician who needs the duplicate image through the network. Hardcopy images can also be made from digital printers, optimizing for the user's preference. The system can have DICOM-compliant output to ensure compatibility with existing imaging network infrastructure.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the KrystalRad 560 (FLAATZ 560) System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes the KrystalRad 560 (FLAATZ 560) as "substantially equivalent" to a predicate device (DRTech FLAATZ 750 system). Acceptance criteria are not explicitly stated as pass/fail thresholds for clinical performance but rather by demonstrating that the new device's performance characteristics (technical specifications) are comparable to or better than the predicate device. The study presented is a comparison to the predicate device, not a standalone clinical trial with specific performance metrics for disease detection.

Criteria (Technical Specification)	Predicate Device (DRTech FLAATZ 750) Performance	KrystalRad 560 (FLAATZ 560) Performance (Reported Device Performance)
Panel Shape	Square	Rectangle
Detector Size	42.9 x 42.9 (cm)	35x43 cm
Dimensions (W x L x H)	482 x 482 x 35 (mm)	383 X 460 X15mm
Pixel Pitch	168 (um)	139 um
Image Size	3072 x 3072 (pixels)	3072 x 2560 pixels
Selenium Thickness	500 (µm)	500 (µm)
Weight (Detector)	6.2 (kg)	3.8kg
DQE @ 0.5lp/mm	48.5%	52.5%
MTF @ 3.5lp/mm	78%	77%
Resolution	3.6lp/mm	3.5lp/mm
Ghosting @ RQA5 Condition	<1%	<1%
Anatomical Sites	General Radiography	General Radiography
Power Requirement	100~~240V~~, 50/60 Hz, Max 2A, Single Phase	100~~240V~~, 50/60 Hz, Max 2A, Single Phase

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

The document does not describe a test set in the context of a clinical performance study with human images. The "acceptance criteria" and "study" are based on technical specifications and performance metrics of the device itself, comparing them to a predicate device. Therefore, there is no sample size of patients or images for a test set, nor information about data provenance in that sense. The comparison is between the technical specifications of two devices.

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

Not applicable. As noted above, there is no clinical test set for which ground truth would be established by experts. The performance metrics (DQE, MTF, Resolution, Ghosting) are engineering measurements of the device's imaging capabilities.

4. Adjudication Method for the Test Set:

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

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:

Not applicable. This submission is for a digital X-ray detector, which replaces film/screen systems. It is not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this submission.

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

Not applicable. The KrystalRad 560 (FLAATZ 560) System is a medical imaging device, not an algorithm, so standalone algorithm performance is not relevant.

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

Not applicable. The evaluation relies on engineering and physical performance measurements (e.g., DQE, MTF, Resolution, Ghosting) of the detector panel, compared against equivalent measurements of a legally marketed predicate device.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device (hardware and basic software for image acquisition/display) and not an AI/ML algorithm that would typically require a training set of images with established ground truth.

9. How the Ground Truth for the Training Set was Established:

Not applicable, for the same reasons as point 8.

Summary

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510(k) Summary K102284 This 510k summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

3 2010

Initial Importer/Distributor	MedicaTechUSA
Address:	50 MaxwellIrvine, CA 92618	JAN
Phone number:	(800) 817-5030
Fax number:	(949) 679-2882
Manufacturer	DRTECH CORP.333-1, Sangdeawon 1-DongJungwon-guSeongnam-shi, Gyeonggi-do 462-807Republic of Korea.
Phone number:	+82 31 730-6800
Fax number:	+82 31 730-6869
Contact Person	George Makar
Email:	george@medicatechusa.com
Phone:	(800) 817-5030
Cell:	(949) 929-5910
Fax:	(949) 679-2882
Device Name and Classification
Trade name/Product Name:	KrystalRad 560 (FLAATZ 560) System
Classification name:	Stationary X-ray System
Common name:	General purpose diagnostic X-ray System
Classification Panel:	Radiology
Product Code:	MQB
Regulation Number:	892.1680

Date Prepared

Substantial Equivalence claimed to:

DRTech FLAATZ 750 (K080064)

Device Description

15.2010

The system enables a user to duplicate images without having to take additional exposures so that the user can easily transmit a duplicate to the second physician who needs the duplicate image through the network.

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Hardcopy images can also be made from digital printers, optimizing for the user's preference. The system can have DICOM-compliant output to ensure compatibility with existing imaging network infrastructure.

Indications for Use

The KrystalRad 560 (FLAATZ 560) Digital X-Ray System is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).

Substantial Equivalence

The KrystalRad 560 (FLAATZ 560) is substantially equivalent to the commercially available DRTech FLAATZ 750 system cleared on January 23, 2010 via 510k K080064. X-ray generation used with the KrystalRad 560 (FLAATZ 560) is identical to the DRTech 750. The KrystalRad 560 (FLAATZ 560) utilizes OmniVision Software while the DRTech FLAATZ 750 system utilizes the proprietary ECOM Omni Vue software to control the system and manage digital images collected

510(k) Number	DRTech Corporation(K080064)	KrystalRad 560 (FLAATZ 560)
Indication for Use	The FLAATZ 750 is indicated for usein general radiographic images ofhuman anatomy. It is intended toreplace radiographic film/screensystems in all general-purposediagnostic procedures (excludingfluoroscopic, angiographic, andmammographic applications).	Same as predicate.
User Interface	Software DrivenTouch Panel LCD +remote control unit +remote console	Same as predicate.
Software	ECOM OmniVue	OmniVisionFDA cleared via 510k K101315
Design	Panel Shape	Square	Rectangle
	Detector Size	42.9 x 42.9 (cm)	35x43 cm
	Dimensions(W x L x H)	482 x 482 x 35 (mm)	383 X 460 X15mm
	Pixel Pitch	168 (um)	139 um
	Image Size	3072 x 3072 (pixels)	3072 x 2560 pixel
	SeleniumThickness	500 (μm)	500 (μm)
	Weight(Detector)	6.2 (kg)	3.8kg
Materials		Amorphous Selenium(a-Se) Detector	Amorphous Selenium(a-Se)
Performance	DQE	48.5% @ 0.5lp/mm	52.5% @ .5lp/mm
	MTF	78% @ 3.5lp/mm	77% @ 3.5lp/mm
	Resolution	3.6lp/mm	3.5lp/mm

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510(k) Number	DRTech Corporation(K080064).	KrystalRad 560 (FLAATZ 560)
Ghosting	<1% @ RQA5 Condition	<1% @RAQ5 conditions
Anatomical Sites	General Radiography	General Radiography
Energy Used and/orDelivered	The Control Box has the followingPower Requirement:100~~240V~~, 50/60 Hz, Max 2A, SinglePhase	The Control Box has the followingPower Requirement:100~~240V~~, 50/60 Hz, Max 2A,Single Phase

General Safety and Effectiveness Concerns

Electrical, mechanical safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28 and EN/IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-2-22 was
test results were satisfactory. In accordance with standard EN/IEC 60601-1-2(2001).

Conclusion

The results of all testing demonstrate that the KrystalRad 560 (FLAATZ 560) does not raise any new significant issues of safety, effectiveness or performance of the device when compare to the existing predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest movement and freedom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Medicatech USA % Mr. Daniel Kamm New Submission Correspondent Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

JAN - 3 2010

Re: K102284

Trade/Device Name: KrystalRad 560 (FLAATZ 560) System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: December 16, 2010 Received: December 21, 2010

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.

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

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Dan

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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JAN - 3 2010

510(k) Number (if known): Klo2284

Device Name: KrystalRad 560 (FLAATZ 560) System

Indications For Use:

ﺎ ﺗﻮﺍﺻﻞ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ

・

, "

The KrystalRad 560 (FLAATZ 560) Digital X-Ray Systems is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Concessor () — La Grossic Devices Evaluation and Safety

510K K102284

ﮧ ﺗﺎ

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.