The Models 2200DR and 1600DR 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.

Device Description

This device represents a new combination of an already cleared solid state digital x-ray acquisition panel and software with the diagnostic x-ray compnents required to make a complete system. The digital panel is the Toshiba wired flat panel detector FDX-4343R, 17 in x 17in. (Cleared in K 143257 as well as other submissions.) The system has been tested with only this model of flat panel detector. The purchaser can select either a "C" arm configuration (1600DR) or an overhead tube crane configuration (2200DR). 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. The system complies with the CDRH Radiological Health performance standard in the Code of Federal Regulations, as well as the voluntary IEC standards IEC 60601-1-2, and IEC60601-2-54. The systems include an AEC feature.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Beijing Polycon Medical Engineering Company's Models 2200DR and 1600DR Digital Stationary Radiographic Systems. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a traditional clinical study with defined performance metrics.

However, based on the information provided, we can infer some aspects and address the questions to the best of our ability within the context of a 510(k) submission for an X-ray system.

1. Table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission for an X-ray system, the "acceptance criteria" are generally related to demonstrating that the device is as safe and effective as a legally marketed predicate device, rather than specific performance metrics against a medical condition's diagnostic accuracy. The key performance metrics for an X-ray system are related to image quality and safety.

Acceptance Criteria Category (Inferred)	Reported Device Performance
Functional Equivalence	Identical indications for use to the predicate device.
Technological Equivalence	Uses a previously cleared digital panel (Toshiba FDX-4343R), the same generator (CPI CMP 200DR), collimator (Ralco R302A), and tube head (Toshiba) as the predicate or other cleared systems. Differences in digital panel configuration (AC operated Wired Ethernet only vs. Battery or AC, wireless/wired) are noted as having no negative impact. Different image acquisition software (ECOM Software) was verified via "Clinical Testing" to operate properly.
Safety Standards Compliance	Conforms to US Performance Standards (CDRH Radiological Health performance standard in 21 CFR 1000-1050), and voluntary IEC standards IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-54. Electrical Safety per IEC-60601. DICOM 3 compliance.
Image Quality (Inferred)	"Clinical images were provided" as 'further evidence' that the "complete system works as intended." The identical image panel (Toshiba FDX4343R) has the same specifications (3008x3072, 143 μm) as in the predicate. No specific quantitative image quality metrics (e.g., spatial resolution, DQE) are provided in this summary.
AEC Functionality	Same as predicate: YES

2. Sample size used for the test set and the data provenance:

Sample Size: The document mentions "Clinical images were provided" for the clinical testing of the ECOM software and to show the complete system works as intended. However, no specific sample size (number of patients or images) for this clinical testing is mentioned.
Data Provenance: Not explicitly stated. Given that the manufacturer is Beijing Polycon Medical Engineering Company, it is plausible the data originated from China, but this is not confirmed. It is also not specified if the data was retrospective or prospective. The statement "Clinical images were provided" suggests pre-existing images were used rather than a newly designed prospective study.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document only mentions that the device is "intended for use by a qualified/trained doctor or technician."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not specified.

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. This document describes a 510(k) submission for a digital X-ray system, not an AI-powered diagnostic tool. Therefore, a MRMC comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported.

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

Standalone Performance: Not applicable. This is an X-ray imaging system, not a standalone diagnostic algorithm. The "clinical testing" mentioned was likely to verify the proper operation of the image acquisition software within the system.

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

Type of Ground Truth: Not specified. For a standard X-ray system's performance evaluation, ground truth would typically relate to image quality assessment by radiologists or technical performance metrics rather than disease-specific pathology or outcomes, but the document does not elaborate on how the "clinical images" were evaluated or what constituted their "ground truth" for proper system operation.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable in the context of this 510(k) summary. This device is an X-ray hardware system with imaging software, not an AI/ML algorithm that requires a "training set" in the conventional sense. The ECOM software would have undergone standard software validation and testing, not AI training.

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

How Ground Truth for Training Set was Established: Not applicable. (See point 8).

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 features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, wave-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

August 4, 2015

Beijing Polycon Medical Engineering Company % Daniel Kamm, P.E. Principal Engineer Kamm and Associates 8870 Ravello Court NAPLES FL 34114

Re: K151219

Trade/Device Name: Models 2200DR and 1600DR Digital Stationary Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MOB Dated: June 24, 2015 Received: June 30, 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) K151219

Device Name

Models 2200DR and 1600DR 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)

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FOR FDA USE ONLY

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

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510(K) Summary, 510(k) K151219 Submitter: Beijing Polycon Medical Engineering Company Building 9, Fu Wai Liang Jia Dian Street Hai Dian Qu , Beijing 100142, P.R. China Tel: 8610-8811-0881 Fax: 8610-88148957 Date Prepared: June 13, 2015 Contact: Xiangchen Liu, President

1. Identification of the Device:

Proprietary-Trade Name: Models 2200DR and 1600DR 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

1. Equivalent legally marketed device: KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems, K143257, MedicaTech USA. Classification Name: Stationary X-Ray System. Product codes KPR and MOB Common/Usual Name: Digital Diagnositc X-Ray System Device Class: II per regulation 21CFR892.1680
Indications for Use The Models 2200DR and 1600DR are intended for use by a qualified/trained doctor or 3. 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.
Description of the Device: This device represents a new combination of an already cleared solid state digital 4. x-ray acquisition panel and software with the diagnostic x-ray compnents required to make a complete system. The digital panel is the Toshiba wired flat panel detector FDX-4343R, 17 in x 17in. (Cleared in K 143257 as well as other submissions.) The system has been tested with only this model of flat panel detector. The purchaser can select either a "C" arm configuration (1600DR) or an overhead tube crane configuration (2200DR). 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. The system complies with the CDRH Radiological Health performance standard in the Code of Federal Regulations, as well as the voluntary IEC standards IEC 60601-1-2, and IEC60601-2-54. The systems include an AEC feature.
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	KrystalRad 1100 andKrystalRad 3000 DigitalStationary RadiographicSystems, K143257,MedicaTech USA.	Models 2200DR and 1600DRDigital StationaryRadiographic Systems,Beijing Polycon MedicalEngineering Company	Difference and Analysis
IntendedUse:	KrystalRad Series is intendedfor use by a qualified/traineddoctor or technician on bothadult and pediatric subjects fortaking diagnostic radiographicexposures of the skull, spinalcolumn, chest. abdomen,extremities, and other bodyparts. Applications can beperformed with the patientsitting, standing, or lying inthe prone or supine position.Not for mammography.	Models 2200DR and 1600DRDigital StationaryRadiographic Systems areintended for use by aqualified/trained doctor ortechnician on both adult andpediatric subjects for takingdiagnostic radiographicexposures of the skull, spinalcolumn, chest. abdomen,extremities, and other bodyparts. Applications can beperformed with the patientsitting, standing, or lying inthe prone or supine position.Not for mammography.(SAME)	NO DIFFERENCE
Configuration ofDigitalPanels	Battery or AC operatedwireless IEEE 802.11n orWired Ethernet	AC operated Wired Ethernetonly.	Difference: There is nochance of wirelessinterference with the Polyconimplementation.
DigitalPanelModels andtheirclearancenumbers	Vieworks/MedicatechFXRD-1717SA/SB,FXRD-1417SA/SB andFXRD-1417WA/WB(K130337)Toshiba: FDX4343R/RPW,FDX3543RP andFDX3543RPW (Del Medical:K140825; O&R: K131121;Sedecal: K130883);PerkinElmer: XRpad 4336MED (K140551)	Toshiba: FDX4343RCleared in the PredicateDevice, K143257	NO DIFFERENCE
Imageacquisitionpanelspecifications	FXRD-1717SA/SB: 3,072 x3,072, 140μmFXRD-1417SA/SB: 2560 x3072, 140μmFXRD-1417WA/WB: 2560 x3072, 140μmFDX4343R/RPW:3008×3072, 143 μmFDX3543RP: 2448×2984, 143μmFDX3543RPW: 2466×3040,140μmXRpad 4336 MED:3556×4320, 100 μm	FDX4343R 3008×3072, 143μm	NO DIFFERENCE
Characteristic	KrystalRad 1100 andKrystalRad 3000 DigitalStationary RadiographicSystems, K143257,MedicaTech USA.	Models 2200DR and 1600DRDigital StationaryRadiographic Systems,Beijing Polycon MedicalEngineering Company	Difference and Analysis
AEC	YES	YES	NO DIFFERENCE
DICOM	DICOM 3	DICOM 3	NO DIFFERENCE
Imageacquisitionsoftware	CrystalRad as cleared inK130377	ECOM Software	DIFFERENT SOFTWARE:Software was as cleared in:K130883. That submissionused the same Toshiba panel,FDX4343R We verifiedproper operation of theECOM software via ClinicalTesting.
PowerSource	AC Line, various voltagesavailable	SAME	NO DIFFERENCE
Photo	Krystalrad 3000	2200DR	NO DIFFERENCE
Alternateconfiguration	KrystalRad 1100	1600DR	NO DIFFERENCE
Generator	CPI CMP 200DR	CPI CMP 200DR	NO DIFFERENCE
Collimator	Ralco R302A	Ralco R302A	NO DIFFERENCE
Tube Head	Toshiba	Toshiba	NO DIFFERENCE
PerformanceStandard	FDA 21CFR1020.30-31	SAME	NO DIFFERENCE
Electricalsafety	Electrical Safety per IEC-60601.UL listed	SAME	NO DIFFERENCE

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Summary of non-clinical testing: We performed integration testing and risk analysis. The results of a 7. 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. The device conforms to this list of voluntary standards:

StandardsNo.	StandardsOrganization	Standards Title	Version	Date
60601-1	IEC	Safety of Electrical Medical Equipment	2005 + A1(2012)	2005 + A1(2012)
60601-1-2	IEC	Electromagnetic Compatibility	2007	2007
60601-2-54	IEC	Particular requirements for the basic safety andessential performance of X-ray equipment forradiography and radioscopy	2009 1ed	2009
PS 3.1 - 3.18(2009)	NEMA	Digital Imaging and Communications inMedicine (DICOM) Set (This applies to theDigital Panel)	3	2009

1. Summary of clinical testing: Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (e.g., use of previously cleared detectors) but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
1. Conclusion: After analyzing software integration validation, safety testing data, and clinical images, it is the conclusion of Beijing Polycon that the "Models 2200DR and 1600DR Digital Stationary Radiographic Systems" 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.

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.