Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard digital radiography components and image processing.

Therapeutic

No.
Explanation: The device is an imaging system designed to generate radiographic images for diagnostic purposes, not to treat or cure a disease or condition.

Diagnostic

No

Explanation: The device is intended for generating radiographic images, not for providing a medical diagnosis. The generated images are for review by a qualified/trained doctor or technician, who would then use those images to make a diagnosis.

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, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "generating radiographic images of human anatomy." This is an in-vivo (within the living body) imaging process, not an in-vitro (outside the living body) diagnostic test.
Device Description: The description details components like an X-ray assembly, wall stand, patient table, and workstation for image acquisition and viewing. These are all characteristic of a medical imaging system used on a patient, not a device that analyzes samples like blood or tissue.
Input Imaging Modality: The input is "Radiographic images," which are generated by passing X-rays through a patient's body.
Anatomical Site: The anatomical site is "Human anatomy," referring to the patient's body.

IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on samples.

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 DigitalDiagnost C50 Digital Radiography System (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 DigitalDiagnost C50 consist 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)

This 510(k) premarket notification contains the technical documentation. which demonstrates that the DigitalDiagnost C50 is substantially equivalent to the currently marketed and predicate DigitalDiagnost C50 ( K163410, January 4, 2017). The technical documentation includes non-clinical verification / validation tests. These tests were performed on the DigitalDiagnost C50 according to the following international and FDA-recognized consensus standards:

AAMI / ANSI ES60601-1: 2005/(R)2012 and C1:2009/(R)2012 (consolidated text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance. (Edition 3.1). FDA/CDRH recognition number 19-4.
IEC 60601-1-2, Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Disturbances - Requirements and tests (Edition 4.0 2014). FDA/CDRH recognition number 19-8.
IEC 60601-1-3, Medical Electrical Equipment · Part 1-3: General Requirements for Basic Safety and Essential Performance-Collateral Standard: Radiation Protection in Diagnostic X-Ray Equipment. (Edition 2.1 2013). FDA/CDRH recognition number 12-269.
IEC60601-2-28 Medical electrical equipment -· Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis, (Edition 2.0 2010-03). FDA/CDRH recognition number 12-204.
IEC 60601-2-54, Medical Electrical Equipment-· Part 2-54: Particular Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Radiography and Radioscopy (Edition 1.1 2015). FDA/CDRH recognition number 12-296.
IEC 60601-1-6, Medical Electrical Equipment . Part 1-6: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Usability (Edition 3.1 2013). FDA/CDRH recognition number 5-89.
IEC 62304 Medical device software Software . life cycle processes (Edition 1.1 2015) FDA/CDRH recognition number 13-79
IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices (Edition 1.0 2015). FDA/CDRH recognition number 5-114.
ISO 14971 Medical devices Application of risk · management to medical devices (Edition 2.0, corrected version, 2007). FDA/CDRH recognition number 5-40.
CFR 1020.30 Diagnostic x-ray systems and their major components.
CFR 1020.31 Radiographic equipment.
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's Guidance document entitled, "Guidance for Industry and FDA Staff - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" ,issued October 2, 2014
Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 28, 2017

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

Non-clinical verification and validation test results demonstrate that DigitalDiagnost C50 :

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, DigitalDiagnost is substantially C50 equivalent to the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017) in terms of safety and effectiveness.

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

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

Furthermore, the SkyPlate E detector and Pixium 4343RCE detector also has similar design, technology and Image acquisition workflow compared to the previously Pixium 4343RG and Varian PaxScan4336W detector used in the marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017). All technical detector characteristics that potentially have an influence on image quality are assessed and verified according to FDA Guidance for Industry and Food and Drug Administration Staff: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices; issued on September 1, 2016.

The DigitalDiagnost C50 is substantially equivalent to Substantial Equivalence Conclusion: the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

Additionally, substantial equivalence was demonstrated non-clinical performance (verification with and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-1-6, IEC 60601-2-28, IEC 62304, and IEC 62366-1.

The results of these tests demonstrate that DigitalDiagnost C50 met the acceptance criteria and is adequate for its intended use.

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

Not Found

Predicate Device(s)

K163410

Reference Device(s)

K191813, K153318, K182973

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

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Philips Healthcare (Suzhou) Co., Lit. % Claire Zhang Advanced Regulatory Engineer No. 258, ZhongYuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 CHINA

Re: K201725

Trade/Device Name: DigitalDiagnost C50 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: June 8, 2020 Received: June 23, 2020

Dear Claire Zhang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

July 10, 2020

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201725

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)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

SPECIAL 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:	June 08, 2020
Manufacturer:	Philips Healthcare (Suzhou) Co., Ltd.
No. 258, Zhong Yuan Road, Suzhou Industrial Park, 215024
Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA
Establishment Registration Number: 3009529630
Contact Person:	Claire Zhang
Advanced Regulatory Engineer
Phone: +86-021-24128746 (cell: +86-133-8217-7838)
Fax: +86-512-68018677
E-mail: Claire.Zhang_1@philips.com
Device Name:	DigitalDiagnost C50
Classification:	Classification Name
Classification Regulation:
Classification Panel:
Device Class:
Product code:	Stationary X-Ray System
21CFR §892.1680
Radiology
Class II
KPR (System, X-Ray, Stationary)
Predicate Device:	Trade Name:
Manufacturer:
510(k) Clearance:
Classification Regulation:
Classification Name:
Classification Panel:
Device Class:
Product Code	DigitalDiagnost C50
Philips Healthcare (Suzhou) Co.,
Ltd.
K163410-January 4, 2017
21 CFR, Part 892.1680
Stationary X-Ray System
Radiology
Class II
KPR
Reference Device 1:	Trade Name:
Manufacturer:
510(k) Clearance:
Classification Regulation:
Classification Name:
Classification Panel:
Device Class:
Product Code	MobileDiagnost WDR 2.2
SEDECAL SA
K191813- August 2, 2019
21CFR 892.1720
Mobile x-ray system
Radiology
Class II
IZL, MQB
Reference Device 2:	Trade Name:	Philips Eleva Workspot with
SkyFlow
	Manufacturer:	Philips Medical Systems
DMC GmbH
	510(k) Clearance:	K153318- December 22, 2015
	Classification Regulation:	21 CFR 892.1680
	Classification Name:	Stationary X-Ray System
	Classification Panel:	Radiology
	Device Class:	Class II
	Product Code	MQB, LLZ
Reference Device 3:	Trade Name:	DigitalDiagnost C90
	Manufacturer:	Philips Medical Systems
DMC GmbH
	510(k) Clearance:	K182973- January 11, 2019
	Classification Regulation:	21CFR 892.1680
	Classification Name:	Stationary X-Ray System
	Classification Panel:	Radiology
	Device Class:	Class II
	Product Code	MQB, KPR, LLZ
Device description:	The DigitalDiagnost C50 Digital Radiography System
(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 DigitalDiagnost C50 consist 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 use: | The DigitalDiagnost C50 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. | |
| Fundamental scientific
technology: | The fundamental scientific technology utilized in the
DigitalDiagnost C50 and the currently marketed and | |

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5

predicate DigitalDiagnost C50 (K163410, January 4, 2017) is equivalent 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 images postprocessing, storage and viewing (See Table 1 comparing the DigitalDiagnost C50 to the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017) 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 DigitalDiagnost C50 when compared to the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017).

The wireless portable detector of the DigitalDiagnost C50 is identical to the wireless portable detector (SkyPlate E) of the currently marketed and reference device 1, MobileDiagnost WDR 2.2 (K191813-August 2, 2019) manufactured by SEDECAL SA. Therefore, both the wireless portable detector (Skyplate E) of the DigitalDiagnost C50 and the currently marketed and reference device 1, MobileDiagnost WDR 2.2 employ identical fundamental scientific technology.

The DigitalDiagnost C50 and the currently marketed and Reference Device 3, DigitalDiagnost C90 (K182973- January 11, 2019) manufactured by Philips Medical Systems DMC GmbH are provided with identical, fixed RAD detector (Pixium 4343RCE), UNIQUE 2 Post Processing software, embedded Windows 10 operating system. Therefore, DigitalDiagnost C50 and the currently marketed and reference device 3, DigitalDiagnost C90 employ identical fundamental scientific technology in fixed RAD detector (Pixium 4343RCE), UNIQUE 2 Post Processing software, embedded Windows 10 operating system.

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| Table 1
Comparison of Technological Characteristics of Currently marketed and Predicate DigitalDiagnost C50

versus the DigitalDiagnost C50
Feature	Predicate Device:
DigitalDiagnost C50
(K163410, January 4, 2017)	Device:
DigitalDiagnost C50	Comment
Basic information
Product Code	KPR	Identical	No difference; thus,
demonstrating SE.
Regulation No.	21 CFR 892.1680	Identical	No difference; thus,
demonstrating SE.
Device Class	II	Identical	No difference: thus.
demonstrating SE.
Electrical
Requirement	Input voltage: 3-phase,
200/208/240/380/400/415/44
0/480/500Vac;
Frequency:50/60Hz;
Current:
Short term: 112A (with
generator M-CABINET
CXA
50kW), 134A (M-CABINET
CXA 65kW);
Long term: 10A.	Identical	No difference; thus,
demonstrating SE.
Design characteristic
X-ray Tube	RO 1750 ROT 380 & SRO
33100 ROT 380	Identical	No difference; thus,
demonstrating SE.
Max Tube
Voltage	150 kV	Identical	No difference; thus,
demonstrating SE.
Focal Spot Size	0.6mm/1.2mm	Identical	No difference: thus.
demonstrating SE.
Tube Max
power	50KW/100KW
(250W equivalent anode
input power)	Identical	No difference; thus,
demonstrating SE.
Anode Type	Rotation	Identical	No difference; thus,
demonstrating SE.
Generator	Philips Healthcare
(Suzhou),
M-CABINET CXA Pro
50kW,
M-CABINET CXA Pro
65kW	Identical	No difference; thus,
demonstrating SE.
Max Power	50KW/65KW	Identical	No difference; thus,
demonstrating SE.
KV range	40-150	Identical	No difference; thus,
demonstrating SE.
Milli ampere sec
(mAs) product	0.4 mAs-600 mAs (with
AEC control)	Identical	No difference; thus,
demonstrating SE.
Collimator
Operation Mode	Manual collimation	Identical	No difference; thus,
demonstrating SE.
Shape of Beam	Rectangular	Identical	No difference; thus,
demonstrating SE.
Detector
Type	Digital Detector	Identical	No difference; thus,
Demonstrating SE.
	Fixed RAD Detector
	Wireless Static Detector
Fixed RAD
Detector	Pixium 4343RG	Pixium 4343RCE
(Note: this detector is
identical to fixed RAD
detector of the currently
marketed and Reference
Device 3, DigitalDiagnost
C90 cleared under
K182973).	The difference between
4343RCE and 4343RG is
scintillator material and other
minor differences of image
area and image matrix as
compared in this table. The
differences don't affect the
safety or effectiveness.
And the fixed RAD detector
Pixium 4343RCE of the
DigitalDiagnost C50 is
identical to the fixed RAD
detector of the currently
marketed and Reference
Device 3, DigitalDiagnost
C90(K182973- January 11,
2019, Philips Medical Systems
DMC).
Thus, demonstrating SE
Wireless Static
Detector	Varian PaxScan4336W	SkyPlate E (Trixell
3543DR)
(Note: this detector is
identical to the Skyplate E
Detector of the currently
marketed and reference
device 1, MobileDiagnost
WDR 2.2 cleared under
K191813).	The Skyplate E Detector of the
proposed DigitalDiagnost C50
is identical to the Skyplate E
Detector of the currently
marketed and Reference
Device 1, MobileDiagnost
WDR 2.2 (K191813- August 2,
2019).
Thus, demonstrating SE
X-ray
Scintillator
Material	GdOS (Fixed: Pixium
4343RG)	Cesium Iodide (Fixed:
Pixium 4343RCE. )
Note: Pixium
4343RCE is identical
to fixed RAD detector
of the currently
marketed and
Reference Device 3,
DigitalDiagnost C90
cleared under
K182973.	The fixed RAD detector of the
proposed DigitalDiagnost C50
and currently marketed and
Reference Device 3,
DigitalDiagnost
C90(K182973- January 11,
2019, Philips Medical Systems
DMC) are both fabricated
from identical Cesium Iodide
material , thus demonstrating
SE.
	GdOS
(Wireless Varian
PaxScan4336W)	Cesium Iodide
(Wireless SkyPlate E)	The Wireless Detector of the
proposed DigitalDiagnost C50
and the currently marketed and
Reference Device 1,
MobileDiagnost WDR 2.2
(K191813- August 2, 2019) are
both fabricated from identical
Cesium Iodide material, thus
demonstrating SE.
Image Area	42.5cm x 42.5cm
(Fixed: Pixium 4343RG)42.7 cm x 34.4 cm
(Wireless: Varian
PaxScan4336W)	42.03cm x 42.54cm
(Fixed: Pixium
4343RCE)34.5 cm x 42.5cm
(Wireless: SkyPlate E)	The image area of the
DigitalDiagnost C50,
provided with fixed RAD
detector is identical to the
image area of the Fixed RAD
Detector of the currently
marketed and Reference
Device 3, DigitalDiagnost
C90(K182973- January 11,
2019, Philips Medical Systems
DMC), thus demonstrating
substantial equivalence
The image area of the proposed
Wireless Detector SkyPlate E
is identical to the Wireless
Detector SkyPlate E of the
currently marketed and
reference device 1,
MobileDiagnost WDR 2.2
(K191813- August 2, 2019,
Sedecal SA,). thus
demonstrating SE.
Image Matrix	2,874 x 2,869
(Fixed: Pixium 4343RG)3,072 x 2,476
(Wireless: Varian
PaxScan4336W)	2,874 x 2840
(Fixed: Pixium
4343RCE)2,156 x 2,653
(Wireless-SkyPlate E)	The image matrix of the
proposed DigitalDiagnost
C50, provided with fixed RAD
detector is similar to the image
matrix of the currently
marketed and Reference
Device 3, DigitalDiagnost
C90(K182973- January 11,
2019, Philips Medical Systems
DMC). thus demonstrating
substantial equivalence
The image matrix of the
proposed DigtialDiagnost C50
provided with wireless detector
SkyPlate E is similar to the
currently marketed and
Reference Device 1,
MobileDiagnost WDR 2.2
(K191813- August 2, 2019,
Sedecal SA). Infinitesimal
change in the image size (X-
ray field) does not impact
clinical Image Quality.
Therefore, they are equivalent
and there is no impact on the
safety and effectiveness of the
device; thus, demonstrating
SE.
Pixel Size
	148 μm (Fixed: Pixium 4343RG)

139 μm (Wireless: Varian PaxScan4336W) | • 148 μm (Fixed: Pixium 4343RCE)

• 160 μm (Wireless-SkyPlate E) | The pixel size of the proposed DigtialDiagnost C50 provided with fixed RAD detector is identical to the pixel size of the currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019,). thus demonstrating substantial equivalence.

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Based on the information provided above, the DigitalDiagnost C50 is considered substantially equivalent to the currently marketed and predicate DigitalDiagnost C50 ( K163410, January 4, 2017) in terms of fundamental scientific technology.

Summary of Non-Clinical Performance data:

This 510(k) premarket notification contains the technical documentation。 which demonstrates that the DigitalDiagnost C50 is substantially equivalent to the currently marketed and predicate DigitalDiagnost C50 ( K163410, January 4, 2017). The technical documentation includes non-clinical verification / validation tests. These tests were performed on the DigitalDiagnost C50 according to the following international and FDArecognized consensus standards:

· International and FDA-recognized consensus standards:
- . AAMI / ANSI ES60601-1: 2005/(R)2012 and C1:2009/(R)2012 (consolidated text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance. (Edition 3.1). FDA/CDRH recognition number 19-4.
- IEC 60601-1-2, Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Disturbances - Requirements and tests (Edition 4.0 2014). FDA/CDRH recognition number 19-8.
- IEC 60601-1-3, Medical Electrical Equipment ● Part 1-3: General Requirements for Basic Safety and Essential Performance-Collateral Standard: Radiation Protection in Diagnostic X-Ray Equipment. (Edition 2.1 2013). FDA/CDRH recognition number 12-269.
- IEC60601-2-28 Medical electrical equipment -● Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis, (Edition 2.0 2010-03). FDA/CDRH recognition number 12-204.
- IEC 60601-2-54, Medical Electrical Equipment-● Part 2-54: Particular Requirements for the Basic

12

Safety and Essential Performance of X-Ray Equipment for Radiography and Radioscopy (Edition 1.1 2015). FDA/CDRH recognition number 12-296.

IEC 60601-1-6, Medical Electrical Equipment . Part 1-6: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Usability (Edition 3.1 2013). FDA/CDRH recognition number 5-89.
IEC 62304 Medical device software Software . life cycle processes (Edition 1.1 2015) FDA/CDRH recognition number 13-79
IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices (Edition 1.0 2015). FDA/CDRH recognition number 5-114.
ISO 14971 Medical devices Application of risk ● management to medical devices (Edition 2.0, corrected version, 2007). FDA/CDRH recognition number 5-40.
· CFR 1020.30 Diagnostic x-ray systems and their major components.
· CFR 1020.31 Radiographic equipment.
· 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's Guidance document entitled, "Guidance for Industry and FDA Staff - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" ,issued October 2, 2014
· Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 28, 2017

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

Non-clinical verification and validation test results demonstrate that DigitalDiagnost C50 :

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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, DigitalDiagnost is substantially C50 equivalent to the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017) in terms of safety and effectiveness.

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

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

Furthermore, the SkyPlate E detector and Pixium 4343RCE detector also has similar design, technology and Image acquisition workflow compared to the previously Pixium 4343RG and Varian PaxScan4336W detector used in the marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017). All technical detector characteristics that potentially have an influence on image quality are assessed and verified according to FDA Guidance for Industry and Food and Drug Administration Staff: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices; issued on September 1, 2016.

The DigitalDiagnost C50 is substantially equivalent to Substantial Equivalence Conclusion: the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

Additionally, substantial equivalence was demonstrated non-clinical performance (verification with and Page 11 of 12

Summary of Clinical Data:

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validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-1-6, IEC 60601-2-28, IEC 62304, and IEC 62366-1.

The results of of these these detests demonstrate that DigitalDiagnost C50 met the acceptance criteria and is adequate for its intended use.