Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard digital radiography system with image post-processing capabilities, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.

Therapeutic

No
This device is an imaging system designed to generate radiographic images for diagnostic purposes, not for treating diseases or conditions.

Diagnostic

No

The device is an imaging system that generates radiographic images for review, post-processing, storage, and viewing, but it does not claim to diagnose.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including a ceiling suspension with X-ray assembly, wall stand, patient table, high voltage generator, and an acquisition and reviewing workstation. This is clearly a hardware-based system with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Philips DigitalDiagnost C50 system is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to generate radiographic images of human anatomy. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body.
Device Description: The components listed (X-ray assembly, wall stand, patient table, generator, workstation) are all typical of an X-ray imaging system used for in-vivo diagnosis.
Input Imaging Modality: X-ray is an in-vivo imaging modality, not an in-vitro method.
Anatomical Site: The device is used on human anatomy, meaning the patient's body directly.

IVD devices are specifically designed to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or treatment. The DigitalDiagnost C50 operates by passing X-rays through the patient's body to create an image, which is a fundamentally different process from in-vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DigitalDiagnost C50 system 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.

Product codes

KPR

Device Description

The Philips DigitalDiagnost C50 Digital Radiography System (Philips DigitalDiagnost C50) 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 DigitalDiagnost C50 consists of the following components: ceiling suspension with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and an 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

human anatomy

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified/trained doctor or technician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical verification and or validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results.

Non-Clinical verification and or validation test results demonstrate that the DigitalDiagnost C50:

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

The DigitalDiagnost C50 did not require a clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes:

Design features;
Indication for use; ●
Fundamental scientific technology;
Non-clinical performance testing; and ●
Safety and effectiveness. ●

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K141381

Reference Device(s)

K161459

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

January 4, 2017

Philips Healthcare (Suzhou) Co., LTD % Alina Zhou Q&R Director No. 258, Zhong Yuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 CHINA

Re: K163410 Trade/Device Name: DigitalDiagnost C50 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: December 01, 2016 Received: December 05, 2016

Dear Alina Zhou:

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.

Michal 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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5 Statement of Indication for Use/Intended Use

3

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K163410

Device Name DigitalDiagnost C50

Indications for Use (Describe)

The DigitalDiagnost C50 system 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.

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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6 510(k) Summary of Safety and Effectiveness

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510(k) Summary of Safety and Effectiveness

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

Date Prepared:	November 25, 2016
Manufacturer:	Philips Healthcare (Suzhou) Co., Ltd.
No. 258, ZhongYuan Road, Suzhou Industrial Park, 215024
Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA
Establishment Registration Number: 3009529630
Contact Person:	Alina Zhou
Q&R Director
Phone: +86-512-67336582
Fax: +86-512-68018677
E-mail: Alina.Zhou@philips.com
Trade Name:	DigitalDiagnost C50
Common Name:	Digital Radiography System
Classification:
Classification Name:	Stationary X-Ray System
Classification Regulation:	21CFR §892.1680
Classification Panel:	Radiology
Device Class:	Class II
Classification Product Code:	KPR (System, X-Ray, Stationary)
Predicate Device :
Trade Name:	DuraDiagnost
Manufacturer:	Philips Healthcare (Suzhou) Co., Ltd.
510(k) Clearance:	K141381 (June 12, 2014)
Classification Regulation:	21 CFR, Part 892.1680
Classification Name:	Stationary X-Ray System
Classification Panel:	Radiology
Device Class:	Class II
Product Code:	KPR, MQB

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Reference Device :	Trade Name:	Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
	Manufacturer:	Varian Medical Systems
	510(k) Clearance:	K161459 (September 06, 2016)
	Classification Regulation:	21CFR §892.1680
	Classification Name:	Solid State X-Ray Imager (flat panel/digital imager)
	Classification Panel:	Radiology
	Device Class:	Class II
	Product Code:	MQB

Device Description The Philips DigitalDiagnost C50 Digital Radiography System (Philips DigitalDiagnost C50) 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 DigitalDiagnost C50 consists of the following components: ceiling suspension with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and an 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.

Indications for The Philips DigitalDiagnost C50 is intended for use in generating Use: radiographic images of human anatomy by a 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.

| Summary of the
Technological
Characteristics &
Fundamental
Scientific
Technology: | The components of the Philips DigitalDiagnost C50 employ
similar basic construction and fundamental scientific technology as
provided with the currently marketed and predicate Philips
DuraDiagnost (K141381 – 06/12/2014) with regards to the
functionality of the following components: integrated tube |
|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | assembly, 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 |

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images post-processing, storage and viewing (see the comparison table comparing the Philips DigitalDiagnost C50 to the currently marketed predicate Philips DuraDiagnost provided below.

The outcome of this comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of the Philips DigitalDiagnost C50 when compared to the currently marketed and predicate Philips DuraDiagnost.

The wireless portable detector of the Philips DigitalDiagnost C50 is identical to the wireless portable detector (PaxScan 4336Wv4) of the currently marketed and reference device. Varian Nexus DR™ Digital X-ray Imaging System (K161459, 09/06/ 2016) manufactured by Varian Medical System. Therefore, both the wireless portable detector of the Philips DigitalDiagnost C50 and the wireless portable detector of the reference device, Varian Nexus DR™ Digital X-ray Imaging System employ identical fundamental scientific technology.

The Fixed detector (Model No. 4343RG) of the Philips DigitalDiagnost C50 is identical to the fixed detector (Model No. 4343RG) of the currently marketed and predicate Philips DuraDiagnost and is manufactured by Trixell Company. Therefore, the fixed detector of the Philips DigitalDiagnost C50 and the currently marketed and predicate DuraDiagnost employ identical fundamental scientific technology.

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| Summary of Technological Characteristics of the Philips DigitalDiagnost C50 to

the Currently Marketed Predicate Devices
Feature	Currently Marketed
and Predicate
Philips DuraDiagnost
(K141381, 06/12/2014)	Proposed
Philips
DigitalDiagnost C50	Comment
X-ray Tube	RO 1750 ROT 360 &
SRO 33100 ROT 360	RO 1750 ROT 380 &
SRO 33100 ROT 380	Both devices utilize similar
x-ray tubes.
The specifications of both
tubes are exactly the same,
including nominal X-ray
tube voltage, nominal focal
spot values, maximum tube
current, maximum anode
heat content, total filtration
(minimum), maximum and
anode heat dissipation.
The only minor difference
is the tube housing which
does not affect the
performance of the tube
and therefore, there is no
impact on the safety and
effectiveness of the device.
Thus, demonstrating SE.
Max Tube
Voltage	150kV	Same	No difference; thus,
demonstrating SE.
Focal Spot Size	0.6mm/1.2mm	Same	No difference; thus,
demonstrating SE.
Tube Maz
Power	50KW/100KW
(250W equivalent anode
input power)	Same	No difference; thus,
demonstrating SE.
Anode Type	Rotation	Same	No difference; thus,
demonstrating SE.
Generator	Philips Healthcare
(Suzhou),
M-CABINET CXA Pro
50kW, M-CABINET
CXA Pro 65kW, M-
CABINET Pro CXA
80kW	Philips Healthcare
(Suzhou),
M-CABINET CXA Pro
50kW,
M-CABINET CXA Pro
65kW	Equivalent. The Philips
DigitalDiagnost C50 is
provided with
50KW/65KW that is also
provided with the currently
marketed and predicate
Philips DuraDiagnost.
Max Power	50KW/65KW/80KW	50KW/65KW	Therefore, no impact on the
safety and effectiveness of
the device. Thus,
demonstrating SE.
KV range	40-150	Same	No difference; thus,
demonstrating SE.
Milli ampere sec
(mAs) product	0.4 mAs-600 mAs (with
AEC control)	Same	No difference; thus,
demonstrating SE.
Collimator
Operation Mode	Manual collimation	Same	No difference; thus,
demonstrating SE.
Shape of Beam	Rectangular	Same	No difference; thus, demonstrating SE.
Detector
Type	Digital Detector
Fixed: GdOS
Wireless: Pixium
3543EZ (CSI)	Digital Detector
Fixed: GdOS
Wireless: PaxScan
4336Wv4 (Gdos)	The Fixed Portable
Detector of the Philips
DigitalDiagnost C50 is
identical to the currently
marketed and predicate
Philips DuraDiagnost.
The wireless detector is of
the Philips
DigitalDiagnost C50 is
identical to the Reference
Device, Nexus DRTM
Digital X-ray Imaging
System (K161259,
09/062016 - Varian
Medical System.)
Therefore, there is no
impact on the safety and
effectiveness of the device;
thus, demonstrating SE.
X-ray Scintillator
Material	GdOS (Fixed)
Cesium Iodide (Wireless)	GdOS (Fixed)
GdOS (Wireless)	The Fixed Portable
Detector of the Philips
DigitalDiagnost C50 is
identical to the currently
marketed and predicate
Philips DuraDiagnost.
The wireless detector of the
Philips DigitalDiagnost
C50 is identical to the
Reference Device, Nexus
DRTM Digital X-ray
Imaging System (K161259,
09/062016 - Varian
Medical System.)
Therefore, there is no
impact on the safety and
effectiveness of the device;
thus, demonstrating SE.
Image Area	42.5cm x 42.5cm (Fixed)
42.4cm x 34.8cm
(wireless)	42.5cm x 42.5cm
(Fixed)
42.7 cm x 34.4 cm
(wireless)	The image area of the
Philips DigitalDiagnost
C50, provided with the
Fixed Portable Detector, is
identical to the currently
marketed and predicate
Philips DuraDiagnost.
The image area of the
Philips DigitalDiagnost
C50, provided with the
wireless detector is

			Device, Nexus DRTM
Digital X-ray Imaging
System (K161259,
09/062016 - Varian
Medical System.)
Therefore, there is no
impact on the safety and
effectiveness of the device;
thus, demonstrating SE.
Image Matrix	2874 x 2869 (Fixed)
2866 x 2350 (wireless)	2874 x 2869 (Fixed)
3072 x 2476 (wireless)	The image matrix of the
Philips DigitalDiagnost
C50, provided with the
Fixed Portable Detector, is
identical to the currently
marketed and predicate
Philips DuraDiagnost.

The image matrix of the
Philips DigitalDiagnost
C50, provided with the
wireless detector, is
identical to the Reference
Device, Nexus DRTM
Digital X-ray Imaging
System (K161259,
09/062016 - Varian
Medical System.)
Therefore, there is no
impact on the safety and
effectiveness of the device;
thus, demonstrating SE. |
| Analog / Digital
(A/D) conversion | 16 bits | Same | No difference; thus,
demonstrating SE. |
| Source to Image Distance (SID) | | | |
| SID | Table: 40-115cm;
Wallstand: 110-245cm | SID depends on
different
configurations, because
the DigitalDiagnost
C50 is a ceiling
suspension X-ray
system. | The slight difference
between the SID of the
DigitalDiagnost C50 and
the currently marketed and
predicate Philips
DuraDiagnost does not
alter the application usage;
as demonstrated through
Section 17 bench testing.

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Summary of Non-The DigitalDiagnost C50 complies with the following international Clinical and FDA-recognized consensus standards: Performance Data:

International and FDA-recognized consensus standards: .
- o 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.
- o 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 2.1 2013-04, O 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, O 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, O 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 Edition 1.1 2015-06, Medical O device software - software life cycle processes.
- ISO 14971 Second edition 2007-03, O Medical devices - Application of risk management to medical devices.
- IEC 62366 Edition 1.1 2014-01, Medical o 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 - September 1, 2016"
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 - August 14 2013."
FDA draft guidance document entitled, "Pediatric Information for X-ray Imaging Device Premarket Notifications issued on May 10, 2012."

Non-Clinical verification and or validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results.

Non-Clinical verification and or validation test results demonstrate that the DigitalDiagnost C50:

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

Therefore, the DigitalDiagnost C50 is substantially equivalent to the primary currently marketed and predicate Philips DuraDiagnost (K141381- 06/12/2014) in terms of safety and effectiveness.

The DigitalDiagnost C50 did not require a clinical study since Summary of Clinical Data: substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes:

Design features;
Indication for use; ●
Fundamental scientific technology;
Non-clinical performance testing; and ●
Safety and effectiveness. ●

Furthermore, one modification included in this submission is to replace the current wireless detector with an equivalent and already cleared wireless detector by Varian Medical Systems (Varian PaxScan 4336Wv4 of the reference device, Varian Nexus

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DR™ Digital X-ray Imaging System (K161459, cleared on 09/06/2016); therefore a clinical image study is not required.

Substantial The DigitalDiagnost C50 is substantially equivalent to the Equivalence currently marketed and predicate Philips DuraDiagnost (K141381 Conclusion: - 06/12/2014) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Also, the wireless detector provided with the DigitalDiagnost C50 is substantially equivalent to the currently marketed and reference device, Varian Nexus DRTM Digital X-ray Imaging System (K161459, 09/06/2016) with regards to the wireless detector (PaxScan 4336Wv4).

Additionally, substantial equivalence was demonstrated with nonclinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, IEC 62304, IEC 62366 and ISO 14971. The results of these tests demonstrate that the DigitalDiagnost C50 met the acceptance criteria and is adequate for its intended use.