The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.

Device Description

The Philips DuraDiagnost Digital Diagnostic Radiographic System (DuraDiagnost) is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients. The Philips DuraDiagnost consist of the following components: Tube column with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Philips DuraDiagnost, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than setting specific performance acceptance criteria for the new device as would be found in a clinical trial protocol. Instead, the "acceptance criteria" here relate to the device meeting recognized standards and exhibiting technical characteristics similar to its predicates.

Feature / Standard	Acceptance Criteria (Implied)	Reported Device Performance (Philips DuraDiagnost)
Technical Design Characteristics		(Demonstrated similar construction and fundamental scientific technology to predicate devices for components like X-ray tube, generator, wall stand, patient table, detector, and workstation. See comparison features below.)
Tube Design	Identical to Philips BuckyVision (RO 1750 & SRO 33100)	RO 1750 & SRO 33100
Max Tube Voltage	Identical to predicate devices (150kV)	150kV
Focal Spot Size	Identical to predicate devices (0.6mm/1.2mm)	0.6mm/1.2mm
Tube Max Power	Identical to Philips BuckyVision (50KW/100KW)	50KW/100KW
Anode Type	Identical to predicate devices (Rotation)	Rotation
Generator Max Power	Identical to Philips BuckyVision (50KW/65KW/80KW)	Identical to Philips BuckyVision (50KW/65KW/80KW)
Generator kV Range	Identical to predicate devices (40-150)	40-150
Generator mAs Product	Identical to Philips BuckyVision (0.5 mAs-600 mAs with AEC control)	0.5 mAs-600 mAs (with AEC control)
Collimator Operation	Manual collimation, same as GE Brivo XR385; also motorized automatic collimation option.	Manual collimation with motorized automatic collimation option
Shape of Beam	Rectangular	Rectangular
Detector Type	Digital Detector (Fixed & Wireless), identical to predicate devices (GE Brivo XR385, Philips BuckyVision, Swissray ddRVersa™ Motion)	Digital Detector (Fixed & Wireless)
X-ray Scintillator Material	Fixed: GdOS, Wireless: Cesium Iodide; identical to predicate devices (GE Brivo XR385, Swissray ddRVersa™ Motion)	Fixed: GdOS, Wireless: Cesium Iodide
Image Area	Wireless: 42.4cm x 34.8cm (identical to Swissray ddRVersa™ Motion); Fixed: 43cm x 43cm; slight differences with other predicates not expected to alter diagnostic image quality.	Wireless: 42.4cm x 34.8cm; Fixed: 43cm x 43cm
Image Matrix Size	Wireless: 2866 x 2350 (identical to Swissray ddRVersa™ Motion); Fixed: 2874 x 2869; slight differences with other predicates not expected to alter diagnostic image resolution.	Wireless: 2866 x 2350; Fixed: 2874 x 2869
A/D Conversion	Identical to Philips BuckyVision and Swissray ddRVersa™ Motion (16 bits).	16 bits
SID	Table: 50-110cm; Wallstand: 100-180cm (slight differences with GE Brivo XR385 not expected to significantly alter application usage).	Table: 50-110cm; Wallstand: 100-180cm
DICOM	DICOM 3.0 compatible (same as all predicate devices).	DICOM 3.0 compatible
Software Platform	Eleva workspot (same as Philips BuckyVision).	Eleva workspot
Compliance with Standards & Guidance	Compliance with all listed international and FDA-recognized consensus standards and FDA Guidance documents.	Complies with AAMI / ANSI ES60601-1, IEC 60601-1-2, 60601-1-3, 60601-2-28, 60601-2-54, IEC 62304, ISO 14971, IEC 62366, CFR 1020.30, CFR 1020.31, and FDA guidance documents related to solid state X-ray imaging, software, wireless technology, and pediatric information.
Diagnostic Image Quality	Similar diagnostic image quality when compared with the predicate devices.	Demonstrated similar diagnostic image quality to predicate devices.
Safety and Effectiveness	Equivalent to predicate devices in terms of safety and effectiveness for its intended use. Overall device is adequate for its intended use.	Demonstrated substantial equivalence in safety and effectiveness compared to predicate devices through design features, fundamental scientific technology, indications for use, and non-clinical performance (verification/validation) tests.

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

Test Set Sample Size: Not applicable. This 510(k) relies on non-clinical performance testing and comparison to predicate devices, not a clinical test set of patient images.
Data Provenance: The data provenance is primarily from bench testing, engineering verification, and validation activities against recognized standards and guidance documents. This is not patient-level data. The manufacturer is Philips Healthcare (Suzhou) Co., Ltd in China.

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

Number of Experts: Not applicable. Since there was no clinical test set of patient images, no experts were used to establish ground truth in this context. The "ground truth" for this submission is related to engineering specifications and compliance with regulatory standards.
Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set of patient images requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical study was not warranted to support this 510(k) submission, since substantial equivalence to the currently marketed and predicate devices was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; and Safety and effectiveness."
Effect Size: Not applicable, as no MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a hardware digital radiographic system with integral software for image acquisition, processing, storage, and viewing. It is not an AI algorithm in the context of standalone performance. Therefore, a "standalone algorithm only" performance study is not applicable. The performance evaluation focuses on the entire system's compliance with standards and equivalence to predicate systems.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:
- Engineering Specifications and Design Features: Comparing the technical characteristics of the DuraDiagnost to those of the predicate devices.
- International and FDA-recognized Consensus Standards: Compliance with electrical safety, EMC, radiation protection, software lifecycle, risk management, and usability standards (e.g., IEC 60601 series, IEC 62304, ISO 14971).
- FDA Guidance Documents: Adherence to specific guidance for solid-state X-ray imaging, software, wireless technology, and pediatric information.
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (GE Brivo XR385, Philips BuckyVision, Swissray ddRVersa™ Motion) serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This submission is for a conventional digital radiographic system and does not involve an AI algorithm with a training set of images. The "training" for such a system would involve engineering design and software development, not machine learning from a dataset.

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

Ground Truth for Training Set: Not applicable, as there is no AI algorithm training set involved.

Summary

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Image /page/0/Picture/0 description: The image shows the word "PHILIPS" in large, bold, black letters. Above and to the right of the word, there is some handwritten text that reads "K14381 Page 1 of 12". The handwritten text is smaller and less distinct than the word "PHILIPS".

510(k) Summary of Safety and Effectiveness

JUN 1 2 2014

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92. .

Date Prepared:	March 21, 2014
Manufacturer:	Philips Healthcare (Suzhou) Co., Ltd.No. 258, Zhong Yuan Road, Suzhou Industrial Park, 215024 Suzhou,Jiangsu Province, PEOPLE'S REPUBLIC OF CHINAEstablishment Registration Number: Not registered yet
Contact Person:	Gordon ShuRegulatory Affairs ManagerPhone: +86-512-67336804Fax: +86-512-68018677E-mail: Gordon.Shu@philips.com
Trade Name:	DuraDiagnost
Common Name:	Digital Diagnostic Radiographic System
Classification:	Classification Name: Stationary X-Ray SystemClassification Regulation: 21CFR §892.1680Classification Panel: RadiologyDevice Class: Class IIClassification Product Code: KPR (System, X-Ray, Stationary)Subsequent Product Code: MQB (solid state x-ray imager (flat panel/digital imager))
Predicate Device 1:	Trade Name: Brivo XR385, Digital Diagnostic Radiographic SystemManufacturer: GE MEDICAL SYSTEM, LCC510(k) Clearance: K103448 (August 12, 2011)Classification Regulation: 21 CFR, Part 892.1680Classification Name: Stationary X-Ray SystemClassification Panel: RadiologyDevice Class: Class IIProduct Code: KPR

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Device Trade Name: Philips BuckyVision Predicate Manufacturer: Philips Medical Systems, Inc. 510(k) Clearance: K982795 (November 24,1998) Classification 21CFR §892.1680 Regulation: Classification Name: Stationary X-Ray System Classification Panel: Radiology Device Class: Class II KPR & MQB Product Code: ddRVersa™ Motion Trade Name: Predicate Device

Manufacturer: Swissray Medical AG 510(k) Clearance: K123005 (December 7, 2012) 21CFR $892.1680 Classification Regulation: Classification Name: Stationary X-Ray System

Classification Panel: Radiology

Device Class:

Class II

Device Code: KPR & MQB

Device description:

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Indications Use:

for

Summarv of the Technological Characteristics & Fundamental Scientific Technology:

The components of the Philips DuraDiagnost employ similar basic construction and fundamental scientific technology as provided with the currently marketed and predicate GE Brivo XR385 and Philips BuckyVision with regards to the functionality of the following components: Integrated tube column, patient table with a floating table top, high-voltage generator, dual-focus rotation anode X-Ray tube, manual beam limiting device, digital detector, wall stand and workstation for images post-processing, storage and viewing (See the comparison Table provided below, comparing the Philips DuraDiagnost to the currently marketed predicate devices). The outcome of this comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of the Philips DuraDiagnost when compared to the currently marketed and predicate devices.

The wireless portable detector (Model No. 3543EZ) of the Philips DuraDiagnost is identical to the wireless portable detector (Model No. 3543EZ) of the currently marketed and predicate ddRVersaTM Motion (K123005 - December 7, 2012) - Swissray Medical AG and is manufactured by Trixell. Therefore, both the wireless portable detector of the Philips DuraDiagnost and the wireless portable detector of the currently marketed and predicate ddRVersa™ Motion employ identical fundamental scientific technology.

Based on the information provided above, the Philips DuraDiagnost is considered substantially equivalent to the currently marketed and predicate device, GE Brivo XR385 (K103448 - August 12, 2011) and Philips Bucky Vision (K982795 - November 24, 1998) in terms of fundamental scientific technology. With regards to wireless portable detector, the Philips DuraDiagnost is considered substantially equivalent to the currently marketed and predicate ddRVersa™ Motion (K123005 - December 7, 2012) - Swissray Medical AG in terms of fundamental scientific technology.

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. . .

Feature	Currentlymarketed andPredicate GE BrivoXR385 (K103448)	Currently marketedand Predicate PhilipsBuckyVision(K982795)	Currently marketedand Predicate SwissrayddRVersa™ Motion(K123005)	PhilipsDuraDiagnost	Comparison Results
Design characteristic	Toshiba E7843X	RO 1750 & SRO 33100	Note: The currentlymarketed and predicateSwissray ddRVersa™Motion (K123005 –December 7, 2012) is onlyused to demonstratesubstantial equivalence tothe wireless portabledetector (model 3543EZ)of the PhilipsDuraDiagnost, since it ismanufactured by the samemanufacturer Trixell.	RO 1750 & SRO 33100	Identical. The PhilipsDuraDiagnost and the currentlymarketed and predicate PhilipsBuckyVision both use theidentical X-ray tube. Thus,demonstrating SE.
Max TubeVoltage	150kV	150kV		150kV	Identical. Thus, demonstratingSE.
Focal spotsize	0.6mm/1.2mm	0.6mm/1.2mm		0.6mm/1.2mm	Identical. Thus, demonstratingSE.
Tube Maxpower	50K W	50KW/100KW		50KW/100KW	Identical. The PhilipsDuraDiagnost and the currentlymarketed and predicate PhilipsBuckyVision both use theidentical X-ray tube. Thus,demonstrating SE.
Anode Type	Rotation	Rotation		Rotation	Identical. Thus, demonstratingSE.

Philips DuraDiagnost 510 (K)
510(K) Summary

・

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Generator	Max Power	KV range	Milli amperesec (mAs)product	CollimatorOperationMode		Shape ofBeam	DetectorType	X-rayScintillatorMaterial	Image Area
Unknown	50KW	40-150	0.02 mAs-512mAs(with AECcontrol)	Manual collimation		Rectangular	Digital Detector (Fixed)	GadoliniumOxysulphide (GdOS)	40.4cm x 40.4 cm			Identical. Thus, demonstratingSE.
EMD Technologies,M-CABINET CXA 50kW,M-CABINET CXA 65kW,M-CABINET CXA 80kW	50KW/65KW/80KW	40-150	0.5 mAs-600 mAs (withAEC control)	Motorized automaticcollimation or manualcollimation	Note: The currentlymarketed and predicateSwissray ddRVersaTMMotion (K123005 –December 7, 2012) is onlyused to demonstratesubstantial equivalence to	Rectangular	Digital Detector (Fixed)	Cesium Iodide	42.5 cm x 42 cm	the wireless portabledetector (model 3543EZ)of the PhilipsDuraDiagnost, since it ismanufactured by the samemanufacturer Trixell.
EMD Technologies,M-CABINET CXA50kW, M-CABINETCXA 65kW, M-CABINET CXA 80kW	50KW/65KW/80KW	40-150	0.5 mAs-600 mAs (withAEC control)	Manual collimation	Identical. The PhilipsDuraDiagnost and the currentlymarketed and predicate PhilipsBuckyVision both use theidentical Generator. Thus,demonstrating SE.	Rectangular	Digital Detector (Wireless)	Cesium Iodide	42.4cm x 34.8cm(wireless)		Digital Detector (Fixed& Wireless)	Identical. The Fixed andWireless Portable Detector of thePhilips DuraDiagnost isidentical to the currentlymarketed and predicate GE'sBrivo XR385, Philips BuckyVision and Swissray'sddRVersa™ Motion in terms ofthe type of the detector. Thus,demonstrating SE.
					Identical. The PhilipsDuraDiagnost and the currentlymarketed and predicate PhilipsBuckyVision both use theidentical power. Thus,demonstrating SE.			GdOS(Fixed)CesiumIodide(Wireless)	43cm x 43cm(Fixed)42.4cm x 34.8cm(wireless)			Identical. The Fixed andWireless Portable Detector of thePhilips DuraDiagnost and thecurrently marketed and predicateGE's Brivo XR385 andSwissray's ddRVersa™ Motionutilize identical scintillatormaterial fabricated from GdOSand Cesium Iodide, respectively.Thus demonstrating SE.
					Identical. Thus, demonstratingSE.							Identical for Wireless PortableDetector.
					Identical. The PhilipsDuraDiagnost and the currentlymarketed and predicate PhilipsBuckyVision both use theidentical mAs. Thus,demonstrating SE.							The Wireless Portable Detectorof the Philips DuraDiagnost and
					Same. The PhilipsDuraDiagnost and the currentlymarketed and predicate GE'sBrivo XR385 both use themanual collimation mode. Thus,demonstrating SE.

Philips DuraDiagnost 510 (K)

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Philips DuraDiagnost 510 (K)

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ImageMatrix Size	2048 x 2048	the currently marketed andpredicate Swissray'sddRVersa™ Motion utilizeidentical image area. Thusdemonstrating SE.Similar for Fixed Detector.
	2874 x 2840	The slight differences betweenthe image area of the PhilipsDuraDiagnost and the currentlymarketed and predicate predicatePhilips BuckyVision and GE'sBrivo XR385 are not anticipatedto significantly alter thediagnostic image quality. Thus,demonstrating SE.
	2866 x 2350 (wireless)	Identical for Wireless PortableDetector.
	2874 x 2869 (Fixed)
	2866 x 2350 (wireless)	The Wireless Portable Detectorof the Philips DuraDiagnost andthe currently marketed andpredicate Swissray'sddRVersa™ Motion utilizeidentical image matrix size. Thusdemonstrating SE.Similar for Fixed Detector.The slight differences betweenthe image matrix size of thePhilips DuraDiagnost and thecurrently marketed and predicate

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PHILIPS

Philips DuraDiagnost 510 (K)
Summary

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Class Concession	Comments of Children Comments of Children
I
-
	l
	l

Analog / Digital (A/D) conversion	14 bits	16 bits	16 bits	16 bits
		Identical. The Philips DuraDiagnost and the currently marketed and predicate Philips BuckyVision and Swissray's ddRVersa™ Motion all use the same A/D conversion. Thus, demonstrating SE.	Note: The currently marketed and predicate Swissray ddRVersa™ Motion (K123005 – December 7, 2012) is only used to demonstrate substantial equivalence to the wireless portable detector (model 3543EZ) of the Philips DuraDiagnost, since it is manufactured by the same manufacturer Trixell.	predicate Philips BuckyVision and GE's Brivo XR385 are not anticipated to significantly alter the diagnostic image resolution. Thus, demonstrating SE.
Source to Image Distance (SID)	Table: 50-110cm;Wallstand: 100-180cm	SID depends on different configurations, because BuckyVision is ceiling suspension X-ray system.	Table: 40-115cm;Wallstand: 110-245cm	The slight differences between the SID of the proposed DuraDiagnost and the currently marketed and predicate GE's Brivo XR385 are not anticipated to significantly alter the application usage. Thus, demonstrating SE.

Philips DuraDiagnost 510 (K)
Summary S10(K) Summary

ﺮ

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	External connectivity
DICOM	DICOM 3.0 compatible	DICOM 3.0 compatible	DICOM 3.0 compatible	Same. Thus, demonstrating SE.
Software platform	Unknown	Eleva workspot(K063781-January 05, 2007)	Eleva workspot	Same. The PhilipsDuraDiagnost and the currentlymarketed predicate PhilipsBuckyVision both use the samesoftware platform. Thus,demonstrating SE.
		Note: The currentlymarketed and predicateSwissray ddRVersa™Motion (K123005 –December 7, 2012) is onlyused to demonstratesubstantial equivalence tothe wireless portabledetector (model 3543EZ)of the PhilipsDuraDiagnost, since it ismanufactured by the samemanufacturer Trixell.	Note: The currentlymarketed and predicateSwissray ddRVersa™Motion (K123005 –December 7, 2012) is onlyused to demonstratesubstantial equivalence tothe wireless portabledetector (model 3543EZ)of the PhilipsDuraDiagnost, since it ismanufactured by the samemanufacturer Trixell.

hilips DuraDiagnost 510 (K)

. ............................................................................................................................................................................

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Summary of Nonclinical Performance Data:

Non-clinical performance testing performed on the Philips DuraDiagnost demonstrates compliance with the following International and FDA-recognized consensus standards and FDA Guidance documents:

AAMI / ANSI ES60601-1: 2005/(R)2012 and C1:2009/(R)2012 . and, a2:2010/(r)2012 (consolidated text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: . General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-1-3 Edition 2.0 2008-01. Medical electrical . equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
. IEC 60601-2-28 Edition 2.0 2010-03, Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis.
. IEC 60601-2-54 Edition 1.0 2009-06, Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.
IEC 62304 First edition 2006-05, Medical device software -. software life cycle processes.
ISO 14971 Second edition 2007-03-01, Medical devices -. Application of risk management to medical devices.
IEC 62366 Edition 1.0 2007-10. Medical devices Application . of usability engineering to medical devices.
CFR 1020.30 Diagnostic x-ray systems and their major . components.
CFR 1020.31 Radiographic equipment. ●

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Device specific guidance document, entitled "Guidance for the . Submission of 510(k)'s for Solid State X-ray Imaging Devices - August 6, 1999."
FDA's Guidance document entitled, "Guidance for the . Content of Premarket Submissions for Software Contained in Medical Devices - May 11, 2005."
FDA guidance document entitled, "Radio Frequency Wireless . Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff - August 13, 2013."
FDA draft guidance document entitled, "Pediatric Information . for X-ray Imaging Device Premarket Notifications issued on May 10, 2012."

Additionally, verification / validation tests have been performed to intended use, the technical claims, requirement address specifications and the risk management results. The test results demonstrate that Philips DuraDiagnost:

Complies with the aforementioned international and FDA-. recognized consensus standards and FDA guidance documents.
Meets the acceptance criteria and is adequate for its . intended use.

Therefore, the Philips DuraDiagnost is substantially equivalent to the currently marketed and predicate device, GE Brivo XR385 (K103448, Aug. 12, 2011) Philips BuckyVision (K982795-Nov.24, 1998) and ddRVersa™ Motion (K123005 - December 7, 2005) - Swissray Medical AG in terms of safety and effectiveness.

Clinical study was not warranted to support this 510(k) submission, since substantial equivalence to the currently marketed and predicate devices was demonstrated with the following attributes:

. Design features;
Clinical Performance

Data:

. Indication for use;
Fundamental scientific technology; and .
Safety and effectiveness. .

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Image /page/11/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The word is black and stands out against a white background. The font is simple and modern.

Substantial Equivalence Conclusion:

The Philips DuraDiagnost is substantially equivalent to the currently marketed and predicate device GE Brivo XR385 (K103448. August 12, 2011) and Philips BuckyVision (K982795, November 24,1998) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. With regards to the wireless portable detector, the Philips DuraDiagnost is considered substantially equivalent in terms of design and fundamental scientific technology to the currently marketed and predicate ddRVersa™ Motion (K123005 -December 7, 2005) - Swissray Medical AG.

Additionally, substantially equivalence was demonstrated with the following:

. Non-clinical performance (verification / validation) tests, which complied with the requirements specified in the international and FDA recognized consensus standards;
Tests identified in the FDA device specific guidance . document entitled, "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices - August 6, 1999." The results of these tests demonstrate that the Philips DuraDiagnost met the acceptance criteria, provides similar diagnostic image quality when compared with the predicate devices and is adequate for its intended use.
Tests identified in the FDA guidance document entitled, . "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff - August 13, 2013." The results of these tests demonstrate that the Philips DuraDiagnost met the acceptance criteria with regards to wireless technology used in the wireless portable Detector and is adequate for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

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

June 12, 2014

Philips Healthcare (Suzhou) Co., Ltd. % Mr. Gordon Shu Regulatory Affairs Manager No. 258, Zhong Yuan Road Suzhou Industrial Park Suzhou, Jiangsu 215024 CHINA

Re: K141381 Trade/Device Name: Duradiagnost Regulation Number: 21 CFR 892.1680 Regulation Name: DuraDiagnost radiographic system Regulatory Class: II Product Code: KPR, MQB Dated: May 20, 2014 Received: May 28, 2014

Dear Mr. Shu:

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

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Page 2—Mr. Gordon Shu

forth in the quality systems (OS) 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 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" (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.

ាប់

Sincerely yours.

Smh.7)

for

Janine M. Morris 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)

K141381

Device Name

DuraDiagnost

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017 See PRA Statement below.

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) (Signalure)

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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.