The Jumong Series Stationary Radiographic System 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.

Device Description

This device represents a new combination of an already cleared solid state digital x-ray acquisition panel with software and diagnostic x-ray compnents required to make a complete system. Film cassettes may be employed in place of the digital panel. The purchaser can select from one of four configurations. The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Varian (RAD-14), and the collimator is the Ralco R225 ACS DHHS. 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. All major components are either UL or CSA listed.

AI/ML Overview

The provided text is a 510(k) summary for the "Jumong Series Stationary Radiographic System." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and performance data from a standalone study. Therefore, much of the requested information cannot be extracted directly from this document.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for image quality or clinical performance that the device was tested against. Instead, it relies on demonstrating that the device meets general safety and performance standards, and that its components (like digital panels) are previously cleared. The "performance" assessment is framed as "bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device" and that the device "conforms to US Performance Standards" and various IEC/NEMA voluntary standards.

Characteristic	Acceptance Criteria (Not explicitly stated as quantitative targets)	Reported Device Performance
Overall Performance	Safe and effective as the predicate device. Conforms to US Performance Standards and listed voluntary international standards.	"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 lists compliance with standards like IEC 60601-1 (Safety of Electrical Medical Equipment), IEC 60601-1-2 (Electromagnetic Compatibility), IEC 60601-1-3 (Radiation protection), IEC 60601-1-6 (Usability), IEC 60601-2-28 (X-ray tube assemblies), IEC 60601-2-54 (X-ray equipment for radiography), IEC 62366 (Usability engineering), and NEMA PS 3.1 - 3.18 (DICOM).
Image Quality	Not explicitly defined with quantitative metrics, but inferred to be comparable to cleared digital panels.	Clinical images were provided; these images were not necessary to establish substantial equivalence but "provide further evidence in addition to the laboratory performance data to show that the complete system works as intended." The digital panels used are previously 510(k) cleared.
Intended Use	Identical to the predicate device.	The Jumong Series has "identical indications for use" as the predicate device.

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

The document mentions that "Clinical images were provided," but does not specify the sample size, data provenance (e.g., country of origin), or whether they were retrospective or prospective. It explicitly states these images "were not necessary to establish substantial equivalence."

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

This information is not provided in the document. The phrase "clinical images were provided" suggests some form of evaluation but no details on expert involvement or ground truth establishment for a test set.

4. Adjudication Method:

This information is not provided in the document.

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

No MRMC comparative effectiveness study is mentioned in the document. The submission focuses on substantial equivalence based on technical characteristics and safety/performance standards, rather than a clinical trial comparing human reader performance.

6. Standalone Performance Study:

The document implies that images were used to show the "complete system works as intended," suggesting some form of standalone evaluation. However, it does not describe a formal standalone performance study with specific metrics, acceptance criteria, or a detailed methodology. The "non-clinical testing" section primarily covers integration, bench, safety, and software validation.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for any clinical image evaluation, given that the clinical images were "not necessary to establish substantial equivalence."

8. Sample Size for the Training Set:

This information is not applicable as the document describes a device (X-ray system), not an AI algorithm that would typically require a training set.

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

This information is not applicable as the document describes a device (X-ray system), not an AI algorithm.

Summary

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

January 13, 2016

SG HealthCare Co., Ltd. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K150816

Trade/Device Name: Jumong Series Stationary Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB Dated: March 20, 2015 Received: March 27, 2015

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of May 8, 2015

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

Michael D'Hara

For

Robert Ochs, 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) K150816

Device Name

Jumong Series Stationary Radiographic Systems

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) K150816 Submitter: SG Healthcare Co., Ltd. 753 ITECO, 150 Jojeong-Daero, Hanam-Si, Gyeonggi-Do, 465-736 Korea Tel : +82-70-7011-6161 FAX : +82-31-737-4954 Contact: YOSEP PARK, sales@sghealthcare.com Date Prepared: April 11, 2015

1. Identification of the Device:

Proprietary-Trade Name: Jumong Series Stationary Radiographic System Classification Name: Stationary X-Ray System, Product codes KPR and MQB Common/Usual Name: Diagnositc X-Ray System Device Class: II per regulation 21CFR 892.1680

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

1. Indications for Use The Jumong Series 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 an already cleared solid state digital x-ray acquisition panel with software and diagnostic x-ray compnents required to make a complete system. Film cassettes may be employed in place of the digital panel. The purchaser can select from one of four configurations. Please see the photos below. The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Varian (RAD-14), and the collimator is the Ralco R225 ACS DHHS. 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. All major components are either UL or CSA listed.
Safety and Effectiveness, comparison to predicate device. This combination device has the same 5. indications for use and very similar technological characteristics as the predicate device, and employs already 510(k) cleared digital panels and software.

6. Substantial Equivalence Chart: Please see the next page.

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Characteristic	Sedecal Nova FA K133782	SG Healthcare, Co. Ltd., Jumong SeriesStationary Radiographic System
Intended Use:	Sedlecal "NOVA FA DR System" isintended for use by a qualified, traineddoctor or technician on both adult andpediatric subjects for taking diagnosticradiographic exposures of the skull,spinal column, chest. abdomen,extremities, and other body parts.Applications can be performed withthe patient sitting, standing, or lying inthe prone or supine position. Not formammography.	Jumong Series 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 theprone or supine position. Not formammography.
Configurationof DigitalPanels	Battery or AC operated wireless IEEE802.11n or Wired Ethernet	SAME
Digital PanelModels andtheir clearancenumbers	CXDI Canon Detector 401C/401CCompact (K103591)CXDI Canon Detector 55C (K091436)CXDI Canon Detector 501C(K111682)	VieworksK122865 Vivix-S WirelessK122866 Vivix-S With VxvueK120020 Vivix-S
Imageacquisitionpanelspecifications	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, FXRD-1717SB)3,072 x 3,072, 140µm orFXRD-1417SA, FXRD-1417SB)2560 x 3072, 140μmWireless: FXRD-1417WA, FXRD-1417WB, 2560 x 3072, 140μm
DICOM	DICOM 3	DICOM 3
WiFi WirelessIEEE802.11n(All others areEthernetTethered.)	Not applicable, but compatible withall Canon panels, including wireless.	K122865 Vivix-S Wireless
Imageacquisitionsoftware	CANON cleared in K111682	Vieworks as cleared in K122866 Vivix-SWith Vxvue
Power Source	AC Line. various voltages available	SAME
Characteristic	Sedecal Nova FA K133782	SG Healthcare, Co. Ltd., Jumong Series Stationary Radiographic System
Photos	Image: Sedecal Nova FA K133782	Image: Jumong MImage: Jumong GeneralImage: Junong E
Alternateconfiguration	Sedecal X-Plus LP Plus, K090238Sedecal	Image: Jumong U
Generator	Sedecal SHF	CPI CMP 200DR
Collimator	Ralco R225	Ralco R225
Characteristic	Sedecal Nova FA K133782	SG Healthcare, Co. Ltd., Jumong SeriesStationary Radiographic System
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. 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
60601-1-3:	IEC	Collateral Standard Radiation protection indiagnostic X ray equipment	2008	2008
60601-1-6	IEC	Collateral standard: Usability	2010 3ed.+A1:2013	2010-2013
60601-2-28	IEC	Particular requirements for the basic safety andessential performance of X-ray tube assembliesfor medical diagnosis	2010, 2ed	2010
60601-2-54	IEC	Particular requirements for the basic safety andessential performance of X-ray equipment forradiography and radioscopy	2009 1ed	2009
62366	IEC	Application of usability engineering to medicaldevices	2007-1ed	2007
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 SG Healthcare that the "Jumong Series" is as safe and effective as the predicate device, has 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.