The ArtPix Mobile EZ2GO, is intended for use in general radiographic examinations by qualified/trained doctors or technicians, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography.

ArtPix Mobile EZ2GO allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Device Description

The modified ArtPix Mobile EZ2GO is a flexible high-resolution Digital Radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patient Imaging. The modified ArtPix Mobile EZ2GO consists of the following components: Tablet Computer, Flat Panel Detectors, Detector Removable batteries & Charger, and other optional components such as External Monitor for Docking Station, USB HUB, Bluetooth DAP device and Fix Room Access Point Support. Images may be transferred via a network using DICOM protocol for printing and storage in PACS.

The modified ArtPix Mobile EZ2GO can be used in combination with any conventional analog radiography system currently using film screen or CR, fixed or mobile, or other system capable of producing general radiography exposures.

The modified Artpix Mobile EZ2GO detector can be shared between multiple Artpix Mobile EZ2GO systems.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Based on the provided document, the device described is ArtPix Mobile EZ2GO, an X-ray system. The document is a 510(k) summary for a Special 510(k) submission, indicating modifications to a previously cleared predicate device, PrestoDR 4143 [K110849](https://510k.innolitics.com/search/K110849).

It's important to note that this document is a 510(k) submission summary, which primarily aims to demonstrate substantial equivalence to a predicate device rather than providing a detailed report of a new clinical trial. Therefore, information regarding certain aspects like "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," and "MRMC comparative effectiveness study" are not typically part of a 510(k) summary for this type of device and are not present in the provided text. These elements are more common for AI/CADe devices or those requiring de novo classification with novel claims.

The "study" proving the device meets the acceptance criteria is primarily a verification and validation (V&V) process focused on demonstrating that the modified device's performance is equivalent to or better than the predicate device and that it meets established engineering and functional requirements, without raising new safety or effectiveness concerns.

1. A table of acceptance criteria and the reported device performance

The document focuses on comparing the modified device (ArtPix Mobile EZ2GO) to its predicate (PrestoDR 4143 [K110849](https://510k.innolitics.com/search/K110849)) across various technical specifications and performance characteristics rather than explicitly stating acceptance criteria in table form for each parameter and then listing the observed performance. Instead, it provides a comparative table and a general conclusion of acceptance.

However, we can infer some "acceptance criteria" from the comparison table (Section 1.9.2) and the V&V section (1.10). The primary acceptance criterion for this 510(k) is substantial equivalence to the predicate device in terms of fundamental scientific technology, indication for use, safety, and effectiveness.

Here's an inferred table based on the provided comparison:

Characteristic	Inferred Acceptance Criteria (Based on Predicate Performance)	ArtPix Mobile EZ2GO Reported Performance
Detectors (CsI)
Pixel Pitch	~148 µm	144 µm / 148 µm (depending on model)
Active Image Area	~41 x 42.5 cm (2775 x 2874 pixels)	Varies by model: e.g., 34.1x 43.2 cm (2372 x 3000 pixels), 33.7 x 41.4 cm (2280 x 2800 pixels)
Dynamic Range	16 bits	16 bit
DQE (0 lp/mm)	64%	66% (for some models)
DQE (1 lp/mm)	52%	51% (for some models)
DQE (2 lp/mm)	42%	39% / 40% (for some models)
DQE (3 lp/mm)	25%	23% / 24% (for some models)
Weight	11.5 Kg	Lighter: 4.7 Kg, 2.8 Kg, 3.0 Kg, 3.2Kg, 1.6 Kg (depending on model)
Detectors (Gadox)
Pixel Pitch	148 µm	148 µm
Active Image Area	41 x 42.5 cm (2775 x 2874 pixels)	Varies by model: e.g., 33.7 x 41.4 cm (2280 x 2800 pixels), 22.2 x 28.4 cm (1500 x 1920 pixels)
Dynamic Range	16 bits	16 bit
MTF (0 lp/mm)	37%	37%
MTF (1 lp/mm)	25%	25%
MTF (2 lp/mm)	17%	17%
MTF (3 lp/mm)	7%	7%
Weight	11.5 Kg	Lighter: 2.8 Kg, 1.6 Kg (depending on model)
Workstation Computer
Processor (min)	i3-540	i5-4310U (Improved)
Memory (min)	2GB, DDR3, 1333 MHz RAM	8GB (Improved)
Operating System	Windows XP	Windows 7 (Updated)
Display	17"/19" LCD Touch Screen, 1280x1024	10.1" LCD 10-Point Multi Touch (Optional 24" with docking station) 1920x1200 (Different form factor, higher res optional)
Disk Storage	500 GB (15,000 images)	250 GB SSD (7,500 images) (Smaller capacity, but deemed sufficient for temporary storage)
Dimensions	36 x 18.3 x 42 cm (10.1 Kg)	27 x 18.8 x 2 cm (1.09 Kg) (Smaller and lighter)
Preview Image Time	6-7 seconds	4 seconds (Improved)
Max Power	700VA	92VA (Lower power consumption)
Functional Equivalence	All basic functions, intended use, and principle of operation should be unchanged.	The device maintains the same basic functions, intended use, and principle of operation.
Safety & Effectiveness	No new safety or effectiveness concerns should be raised.	V&V indicated no critical, safety, efficacy or blocking issues.
Compliance with Standards	Adherence to relevant IEC, ISO, NEMA, CFR standards.	List of 12 standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971, CFR 1020.30/31) met.

Conclusion from the document: "The modified ArtPix Mobile EZ2GO system passed its acceptance criteria and is recommended for release."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "sample size" in terms of patient data or images for testing the device's diagnostic performance, as it is a technical modification to an existing X-ray system rather than a new AI/CAD device. The "test set" in this context refers to the device itself being subjected to engineering verification and validation.

Sample Size for Test Set: Not applicable in the context of patient data or clinical images. The testing refers to the system hardware and software.
Data Provenance: Not applicable. The V&V focused on the device's technical specifications and functionality.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided and is generally not required for a 510(k) summary concerning technical modifications to an X-ray imaging system. Establishing ground truth by experts is relevant for assessing diagnostic accuracy, which is not the primary focus of this type of submission (since the diagnostic capability relies on the predicate's established performance and the fundamental imaging physics).

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

This information is not provided and is not typically relevant for this type of 510(k) submission. Adjudication methods are used in clinical trials, particularly for diagnostic algorithms, where there might be disagreement among reviewers regarding the ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done or reported. This type of study is specific to devices, especially AI/CAD, that assist human readers in making diagnoses. The ArtPix Mobile EZ2GO is an X-ray imaging system itself, not an AI software. The submission focuses on demonstrating that the new hardware and software components maintain diagnostic image quality and system functionality equivalent to the predicate.

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

No standalone algorithm performance study was done or reported. The device is an integral imaging system requiring human operation (qualified/trained doctors or technicians). The submission does not claim any autonomous algorithmic diagnostic capabilities.

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

Since this is not a diagnostic AI/CAD device but an imaging system, the "ground truth" concept in the traditional sense (e.g., pathology for disease detection) is not directly applicable to the V&V described. The V&V focused on:

Expected performance of software functions ("pass/fail" based on test protocols).
Correctness of system integration.
Measured image quality metrics (DQE, MTF) against expected engineering specifications which are themselves proxies for producing diagnostic quality images.
Adherence to safety and electrical standards.

So, the "ground truth" essentially refers to engineered specifications and functional requirements.

8. The sample size for the training set

Not applicable. The ArtPix Mobile EZ2GO is an X-ray imaging device, not an AI/machine learning algorithm that requires a training set of data.

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

Not applicable. (See point 8).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, wave-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

September 22, 2016

CMT Medical Technologies, Ltd. % Ms. Lilia Schlosberg Director of Quality and Regulatory Affairs Hacarmel St. Bld 7/2, POB 111, Industrial Park Yoqneam Ilit, 20692 ISRAEL

Re: K162224

Trade/Device Name: ArtPix Mobile EZ2GO Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB Dated: August 21, 2016 Received: August 24, 2016

Dear Ms. Schlosberg:

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.

{1}------------------------------------------------

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.

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) K162224

Device Name ArtPix Mobile EZ2GO

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

1. 510(k) Summary K162224

1.1. Proprietary Device Name:

ArtPix Mobile EZ2GO

1.2. Establishment Name and Registration Number of Submitter

Manufacture Name: CMT Medical Technologies Ltd. Hacarmel St, Building 7/2 Industrial Park Yokneam Illit 20692 Israel

Registration: 8030112

Submission contact: Lilia Schlosberg Regulatory Affairs Director Tel: +972- 4- 8566233 Mobile: +972- 53 -6247071 Fax: E-mail: lilia.schlosberg@cmt-med.com

1.3. Device 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)
Subsequent Product Code:	MQB - solid-state X-Ray imager (flat panel / digital imager)

1.4. Reason for 510K Submission

Special 510K Submission

1.5. Identification of Legally Marketed equivalent Devices

PrestoDR 4143 K110849

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)
Subsequent Product Code:	MQB - solid-state X-Ray imager (flat panel / digital imager)

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1.6. Device Description

The modified Artpix Mobile EZ2GO detector can be shared between multiple Artpix Mobile EZ2GO systems.

1.7. The Device Intended and Indications for Use

Indications for use

Statement: CMT Medical Technologies Ltd hereby states that in terms of fundamental scientific technology, indication for use, safety and effectiveness the submitted modified The ArtPix Mobile EZ2GO device is substantially equivalent to the currently marketed predicate device PrestoDR 4143 K110849.

1.8. Standards & Guidance

The Modified ArtPix Mobile EZ2GO complies with the following International and FDA recognized consensus and FDA Guidance:

EN/IEC/UL IEC 60601-1 31d edition "Medical Electrical equipment. Part 1: General requirements for safety".
IEC 60601-1-2 3te edition Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-6:2013-Ed.3.1 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 62304:2006 Medical device software Software life cycle processes

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IEC 60601-2-54:2009-Ed.1.0 Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy IEC 60601-2-54:2009-Ed.1.0/Cor.1:2010
IEC 60601-1-3:2008-Ed.2.0 Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment
IEC TR 60878, "Graphical symbols for electrical equipment in medical practice"
NEMA PS 3.1 1 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set.
EN ISO 14971:2012 Application of risk management to medical devices
ISO 15223-1:2012, Medical devices -- Symbols to be used with medical device labels, labeling and information to be supplied
CFR 1020.30 Diagnostic x-ray systems and their major components.
CFR 1020.31 Radiographic equipment.
Device specific guidance document, titled "Guidance for the Submission of 510(k)'s for A Solid State X-ray Imaging Devices August 6, 1999,"
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 10993-1:2009/Cor.1:2010

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1.9. Summary of the Basis for Substantial Equivalence

This submission of the ArtPix Mobile EZ2GO modification presents changes of the legally marketed unmodified device PRESTODR 4143 K110849 .

The ArtPix Mobile EZ2GO is a Digital Radiography system, featuring the Pixium Portable 3543EZ / 2430EZ family Portable Flat Panel Detectors manufactured by Trixell (Pixium Portable 3543EZ, Pixium Portable 3543EZ-C,Pixium Portable 3543EZh-C, Pixium Portable 3543EZ-G, Pixium Portable 2430EZ-C, Pixium Portable 2430EZ-G, Pixium Portable 3543EZh Siemens branded "MAX wi-D", Pixium Portable 2430EZ Siemens branded "MAX mini") and CMT's proprietary technology, which incorporates a tablet computer and state of the art objectoriented software.

The legally marketed PRESTODR 4143 K110849 has been modified: To integrate the Pixium 3543EZ / 2430EZ family Portable Flat Panel Detectors and improve cost effectiveness. Aging technologies and components (hardware and software) have been redesigned. The devices major functions, intended use and principle of operation were not changed.

The modified device ArtPix Mobile EZ2GO consists of almost the same architecture, technologies and algorithms of the predicate PRESTODR 4143 K110849. The topics of the design modifications are presented below:

Hardware modifications:

The predicate device PRESTODR 4143 K110849 was minorly modified:

1. Predicate device PRESTODR 4143 K110849 supports Pixium 4143 FPD (Flat Panel Detector) and Pixium Portable 3543 FPD. The modified device ArtPix Mobile EZ2GO is using the Pixium 3543EZ / 2430EZ family Portable Flat Panel Detectors. The Pixium Flat Panel Detectors supported in the modified device ArtPix Mobile EZ2GO have the same architecture and functionality as in the PRESTODR 4143 K110849, and have already been cleared by FDA in the currently marketed (K141440) dicomPACS DX-R -Oehm und Rehbein GmbH.
1. The PRESTODR 4143 K110849 PC computer was replaced by ArtPix Mobile EZ2GO tablet. In terms of technical performance (Processing Capabilities, Display and Touch), the tablet is no worse than the stationary PC used in PrestoDR 4143, except for hard drive capacity, which is a marginal feature with no impact on the fundamental scientific technology, indication for use, safety and effectiveness.

Software modifications:

The software basic functions were not changed. User interface was changed in order to be upto-date with the modern applications. Additional code was added to support the Pixium 3543EZ / 2430EZ family Portable Flat Panel Detectors.

The submitted device description includes enhanced connectivity, processing time, convenience of use, production ability, and serviceability.

Summary: This submission presents design changes. The modified device ArtPix Mobile EZ2GO is compared to the predicate PRESTODR 4143 K110849. It has the same intended use

{7}------------------------------------------------

(see the comparison table, section 4.2below). The changed device has almost the same technological and performance characteristics of the predicate devices (see the comparison table, section 0) and, in CMT's opinion, these modifications do not raise new types of safety or effectiveness concerns. This submission includes detailed device descriptive and performance information (see sections 1-6 and appendices A-H) that demonstrate that the device is substantially equivalent to the predicate device.

1.9.1. Comparison of indications for use

	Comparisoncontent	PrestoDR 4143	ArtPix Mobile EZ2GO
1	K number	K110849
2	Owner	CMT Medical Technologies Ltd	CMT Medical Technologies Ltd
3	Indication foruse	The PrestoDR 4143 , is intended foruse in general radiographicexaminations, wherever conventionalscreen-film systems may be used,excluding fluoroscopy, angiographyand mammography. PrestoDR 4143allows imaging of the skull, chest,shoulders, spine, abdomen, pelvisand extremities.	The ArtPix Mobile EZ2GO, isintended for use in generalradiographic examinations byqualified/trained doctors ortechnicians, wherever conventionalscreen-film systems may be used,excluding fluoroscopy, angiographyand mammography.ArtPix Mobile EZ2GO allowsimaging of the skull, chest,shoulders, spine, abdomen, andextremities. Applications can beperformed with the patient sitting,standing, or lying in the prone orsupine position.

The indications of use of the predicate PrestoDR 4143 K110849 and the modified ArtPix Mobile EZ2GO are identical, except for slight language modifications.

{8}------------------------------------------------

Performance & Technological Characteristics Compariso 1.9.2.

Detectors 1.9.2.1.

Divinne D	Discium Dorbolo	Divitume	Divinne 41490
			PrestoDR 414
			Predicate K1108
			Detectors with CsI scintillator	ﺗ

System	Model	Pixel Pitch	Active Image Area	Dynamic Range	DQE (typical values)	Weight
Predicate K110849PrestoDR 4143Pixium 4143C	Pixium 4143C	148 μm	41 x 42.5 cm(16.2" x 16.7")2775 x 2874 usable pixels	16 bits	64% at 0 lp/mm52% at 1 lp/mm42% at 2 lp/mm25% at 3 lp/mm	11.5 Kg25.3 lbs
ArtPix EZ2GO	Pixium Portable 3543	144 μm	34.1x 43.2 cm2(13.4" x17" /2372 x 3000 usable pixels	16 bit	66% at 0 lp/mm51% at 1 lp/mm39% at 2 lp/mm23% at 3 lp/mm	4.7 Kg8.5 lbs
	Pixium Portable 3543EZ		33.7 x 41.4 cm(13.26" x 16.30") / 2280 x 2800 usable pixels			2.8 Kg6.17 lbs
	Pixium Portable 3543EZ-C	148 μm	34.4 x 42.1 cm(13.54" x 16.57" /2330 x 2846 usable pixels)	16 bit	66% at 0 lp/mm50% at 1 lp/mm40% at 2 lp/mm24% at 3 lp/mm	3.0 Kg6.61 lbs
	Pixium Portable 3543EZh-C		34.4 x 42.1 cm(13.54" x 16.57" /2330 x 2846 usable pixels)			2.8 Kg6.17 lbs
	Pixium Portable 2430 EZ-C		22.2 x 28.4 cm(8.74" x 11.18" /1500 x 1920 usable pixels)			1.6 Kg3.52 lbs
	Pixium Portable 3543EZh (MAX wi-D)		34.4 x 42.1 cm2(13.54" x16.57" / 2330 x2846 usable pixels)			3.2Kg7.05 lbs
	Pixium Portable 2430EZ (MAX mini)		22.2 x 28.4 cm2(8.74" x 11.18" /1500 x 1920 usable pixels)			1.6 Kg3.52 lbs

The Pixium Portable 3543EZ / 2430EZ FPD family of detectors that are used in the modified ArtPix Mobile EZ2GO ha
already been cleared by FDA in in the currently marketed (K14

{9}------------------------------------------------

Detectors with Gadox scintillat ് എ

System		ArtPix EZ2GO
Model	Predicate K110849PrestoDR 4143Pixium 4143G	Pixium Portable3543EZ-G	Pixium Portable2430 EZ-G
Pixel Pitch	148 μm	148 μm	148 μm
Active Image Area	41 x 42.5 cm (16.2" x 16.7")2775 x 2874 usable pixels	33.7 x 41.4 cm(13.26" x 16.30" / 2280 x 2800 usablepixels)	22.2 x 28.4 cm(8.74" x 11.18" / 1500 x 1920 usablepixels)
Dynamic Range	16 bits	16 bit	16 bit
MTF (typical values)	37% at 0 lp/mm25% at 1 lp/mm17% at 2 lp/mm7% at 3 lp/mm	37% at 0 lp/mm25% at 1 lp/mm17% at 2 lp/mm7% at 3 lp/mm	37% at 0 lp/mm25% at 1 lp/mm17% at 2 lp/mm7% at 3 lp/mm
Weight	11.5 Kg25.3 lbs	2.8 Kg6.17 lbs	1.6 Kg3.52 lbs
System		Predicate K110849PrestoDR 4143	ArtPix EZ2GO
WorkstationComputer* min requirements	Processor*	i3-540	i5-4310U
	Memory*	2GB, DDR3, 1333 MHz RAM	8GB
	OperatingSystem	Windows XP	Windows 7
	Interfaces	One 1Gig LAN for FPD (WiFi access point)and One 1Gig LAN for DICOM networkdata connection	One WiFi AP for FPD and One 1Gig LANfor DICOM network data connection
	Display	Color 17"/19" LCD Touch Screen,1280x1024 pixels	10.1" LCD 10-Point Multi Touch ScreenOptional 24" (with docking station)1920x1200 pixels
	Acquisition -Patient dataentry	Manually or automatically from theDICOM Worklist	Manually or automatically from theDICOM Worklist
	Acquisition -Patient dataentry	Urgent patient registration (includingupdate)	Urgent patient registration (includingupdate)
		Multiple Examinations Handling	Multiple Examinations Handling
	Reviewing &Processing	User-selectable images	User-selectable images
	Reviewing &Processing	Window/level	Window/level
		Window polarity inversion	Window polarity inversion
		Image inversion: Rotation of the image by90°, 180° and 270°. Horizontal and verticalreverse.	Image inversion: Rotation of the image by90°, 180° and 270°. Horizontal and verticalreverse.
		Electronic zoom with pan & scrollcapabilities	Electronic zoom with pan & scrollcapabilities
		Segmentation based image processingand contrast enhancement	Segmentation based image processingand contrast enhancement
		Operator selectable anatomicalprograms	Operator selectable anatomicalprograms Automatic background filming
		Preview image typically within 6-7 secondsafter exposure @ 0.5sec integration time	Preview image typically within 4 secondsafter exposure @ 0.5sec integration time
		Selectable automatic, semi-automatic ormanual storage and printing	Selectable automatic, semi-automatic ormanual storage and printing
	DICOM 3.0Connectivity	Print: Interface to up to 10 DICOM-compliant printers	Print: Interface to up to 10 DICOM-compliant printers
		Store: Interface to up to 10 DICOMStorage servers	Store: Interface to up to 10 DICOMStorage servers
		MWL: Interface to Hospital / Radiologyinformation system's Modality Worklistincluding patient registration and studyinformation (optional)	MWL: Interface to Hospital / Radiologyinformation system's Modality Worklistincluding patient registration and studyinformation (optional)
	Disk Storage*	Hard-disk: 500 GB (or higher capacity)enabling at least 15,000 image storage.	Hard-disk: 250 GB SSD (or highercapacity) enabling at least 7,500 imagestorage. Drive is used for temporarystorage only, and not for archivepurpose. From usability stand-point 7,500images is much more than needed.
	Dimensions	36 (H) x 18.3 (W) x 42 (L) cm14.2" (H) x 7.2" (W) x 16.5" (L)	27 (H) x 18.8 (W) x 2 (L)cm10.6" (H) x 7.4" (W) x 0.8" (L)
	Weight	10.1 Kg	1.09 Kg
System		PredicatePrestoDR 4143	ArtPix EZ2GO
Bucky		Optional item, including grid and AEC	Provided by OEM. In stationary rooms only(including grid and AEC). No electricalconnection to Artpix EZ2GO.
Power DistributionUnit		Provides power to FPD	N/A (FPD is powered by a battery)
Power Requirements	AC Voltage	100-240V	100-240V
	Max Power	700VA	92VA (27VA (Monitor), 65VA (Tablet))
	LineFrequency	50-60 Hz	50-60 Hz
Digital SystemStorage andTransport	Temperature	-20 - 60°C	-20 - 60°C
	RelativeHumidity	10 - 90%	10 - 90%
	AtmosphericPressure	70 - 106 kPa	70 - 106 kPa
Regulatory Compliance		IEC 60601-1-1, IEC 60601-1-2 (only when allsystem's hardware supplied by Thales)ISO 15223, IEC 60878, ISO 14971Compliant with HIPAA requirements.	IEC 60601-1-1, IEC 60601-1-2 (only when allsystem's hardware supplied by Thales)ISO 15223, IEC 60878, ISO 14971Compliant with HIPAA requirements.

The Pixium Portable 3543EZ / 2430EZ FPD family of detectors that are used in the modified ArtPix Mobile EZ2GO I
already been cleared by FDA in in the currently marketed (K141

{10}------------------------------------------------

1.9.2.2. System

{11}------------------------------------------------

1.10. Verification, Validation (V&V)

The V&V processes of the modified PrestoDR Portable have been preformed in several steps as follows:

a. The programmers performed software unit tests during the coding phase. Detected bugs were corrected on line.
b. The Software was integrated into a software version, which was installed into the target ArtPix Mobile EZ2GO modified system. A software test document was prepared prior to the tests. That document presents the case scenario (test protocol) and includes the pass/ fails ("expected results") criteria. The software was integrated and tested with the target system. The (positive /negative) results were documented in the test document.
c. System bench tests were performed by CMT Medical Technologies Ltd. Residual software anomalies that were detected during this stage were recorded to and corrected.
d. The system performance of the modified ArtPix Mobile EZ2GO was validated by measuring the image quality.
e. RMF and System Requirements were tested. No critical, Safety, efficacy or blocking remained open.

Conclusion:

The modified ArtPix Mobile EZ2GO system passed its acceptance criteria and is recommended for release.

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.