← Product Code [KPR](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR) · K162224
# ArtPix Mobile EZ2GO (K162224)
_Cmt Medical Technologies, Ltd. · KPR · Sep 22, 2016 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K162224
## Device Facts
- **Applicant:** Cmt Medical Technologies, Ltd.
- **Product Code:** [KPR](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR.md)
- **Decision Date:** Sep 22, 2016
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 892.1680
- **Device Class:** Class 2
- **Review Panel:** Radiology
## Indications for Use
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 Story
ArtPix Mobile EZ2GO is a digital radiography (DR) system for general radiographic examinations. It captures X-ray images using portable flat-panel detectors (FPDs) and processes them via a tablet computer. The system is used by qualified doctors or technicians in clinical settings. Inputs are X-ray exposures; the system transforms these into digital images displayed on the tablet. Output features include window/level adjustment, image rotation, inversion, zoom, and contrast enhancement. Images are transferred via DICOM to PACS or printers. The device improves workflow efficiency and portability compared to traditional systems. It benefits patients by enabling rapid, high-resolution imaging in various positions (sitting, standing, lying).
## Clinical Evidence
Bench testing only. Validation included software unit testing, system integration testing, and image quality performance measurements. All system requirements and risk management files were verified with no open critical safety or efficacy issues.
## Technological Characteristics
Digital radiography system using Pixium Portable 3543EZ/2430EZ flat-panel detectors (CsI or Gadox scintillators). Tablet-based workstation (i5-4310U, 8GB RAM, Windows 7). Connectivity via WiFi AP and 1Gig LAN (DICOM 3.0). Complies with IEC 60601-1, IEC 60601-1-2, IEC 62304, and ISO 14971. Power: 100-240V AC.
## Regulatory 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.
## Special Controls
*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.
## Predicate Devices
- PrestoDR 4143 ([K110849](/device/K110849.md))
## Reference Devices
- dicomPACS DX-R ([K141440](/device/K141440.md))
## Submission Summary (Full Text)
> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).
{0}------------------------------------------------
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
{2}------------------------------------------------
#### Indications for Use
510(k) Number (if known) K162224
Device Name ArtPix Mobile EZ2GO
Indications for Use (Describe)
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
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.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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) |
{4}------------------------------------------------
# 1.6. 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.
# 1.7. The Device Intended and Indications for Use
## Indications for use
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.
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
{5}------------------------------------------------
- > 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
{6}------------------------------------------------
# 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.
- 2. 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
| | Comparison
content | PrestoDR 4143 | ArtPix Mobile EZ2GO |
|---|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | K number | K110849 | |
| 2 | Owner | CMT Medical Technologies Ltd | CMT Medical Technologies Ltd |
| 3 | Indication for
use | The PrestoDR 4143 , is intended for
use in general radiographic
examinations, wherever conventional
screen-film systems may be used,
excluding fluoroscopy, angiography
and mammography. PrestoDR 4143
allows imaging of the skull, chest,
shoulders, spine, abdomen, pelvis
and extremities. | 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. |
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 K110849
PrestoDR 4143
Pixium 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/mm
52% at 1 lp/mm
42% at 2 lp/mm
25% at 3 lp/mm | 11.5 Kg
25.3 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/mm
51% at 1 lp/mm
39% at 2 lp/mm
23% at 3 lp/mm | 4.7 Kg
8.5 lbs |
| | Pixium Portable 3543EZ | | 33.7 x 41.4 cm
(13.26" x 16.30") / 2280 x 2800 usable pixels | | | 2.8 Kg
6.17 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/mm
50% at 1 lp/mm
40% at 2 lp/mm
24% at 3 lp/mm | 3.0 Kg
6.61 lbs |
| | Pixium Portable 3543EZh-C | | 34.4 x 42.1 cm
(13.54" x 16.57" /
2330 x 2846 usable pixels) | | | 2.8 Kg
6.17 lbs |
| | Pixium Portable 2430 EZ-C | | 22.2 x 28.4 cm
(8.74" x 11.18" /
1500 x 1920 usable pixels) | | | 1.6 Kg
3.52 lbs |
| | Pixium Portable 3543EZh (MAX wi-D) | | 34.4 x 42.1 cm2
(13.54" x
16.57" / 2330 x
2846 usable pixels) | | | 3.2Kg
7.05 lbs |
| | Pixium Portable 2430EZ (MAX mini) | | 22.2 x 28.4 cm2
(8.74" x 11.18" /
1500 x 1920 usable pixels) | | | 1.6 Kg
3.52 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 K110849
PrestoDR 4143
Pixium 4143G | Pixium Portable
3543EZ-G | Pixium Portable
2430 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 usable
pixels) | 22.2 x 28.4 cm
(8.74" x 11.18" / 1500 x 1920 usable
pixels) |
| Dynamic Range | 16 bits | 16 bit | 16 bit |
| MTF (typical values) | 37% at 0 lp/mm
25% at 1 lp/mm
17% at 2 lp/mm
7% at 3 lp/mm | 37% at 0 lp/mm
25% at 1 lp/mm
17% at 2 lp/mm
7% at 3 lp/mm | 37% at 0 lp/mm
25% at 1 lp/mm
17% at 2 lp/mm
7% at 3 lp/mm |
| Weight | 11.5 Kg
25.3 lbs | 2.8 Kg
6.17 lbs | 1.6 Kg
3.52 lbs |
| System | | Predicate K110849
PrestoDR 4143 | ArtPix EZ2GO |
| Workstation
Computer
* min requirements | Processor* | i3-540 | i5-4310U |
| | Memory* | 2GB, DDR3, 1333 MHz RAM | 8GB |
| | Operating
System | Windows XP | Windows 7 |
| | Interfaces | One 1Gig LAN for FPD (WiFi access point)
and One 1Gig LAN for DICOM network
data connection | One WiFi AP for FPD and One 1Gig LAN
for DICOM network data connection |
| | Display | Color 17"/19" LCD Touch Screen,
1280x1024 pixels | 10.1" LCD 10-Point Multi Touch Screen
Optional 24" (with docking station)
1920x1200 pixels |
| | Acquisition -
Patient data
entry | Manually or automatically from the
DICOM Worklist | Manually or automatically from the
DICOM Worklist |
| | Acquisition -
Patient data
entry | Urgent patient registration (including
update) | Urgent patient registration (including
update) |
| | | 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 by
90°, 180° and 270°. Horizontal and vertical
reverse. | Image inversion: Rotation of the image by
90°, 180° and 270°. Horizontal and vertical
reverse. |
| | | Electronic zoom with pan & scroll
capabilities | Electronic zoom with pan & scroll
capabilities |
| | | Segmentation based image processing
and contrast enhancement | Segmentation based image processing
and contrast enhancement |
| | | Operator selectable anatomical
programs | Operator selectable anatomical
programs Automatic background filming |
| | | Preview image typically within 6-7 seconds
after exposure @ 0.5sec integration time | Preview image typically within 4 seconds
after exposure @ 0.5sec integration time |
| | | Selectable automatic, semi-automatic or
manual storage and printing | Selectable automatic, semi-automatic or
manual storage and printing |
| | DICOM 3.0
Connectivity | Print: Interface to up to 10 DICOM-
compliant printers | Print: Interface to up to 10 DICOM-
compliant printers |
| | | Store: Interface to up to 10 DICOM
Storage servers | Store: Interface to up to 10 DICOM
Storage servers |
| | | MWL: Interface to Hospital / Radiology
information system's Modality Worklist
including patient registration and study
information (optional) | MWL: Interface to Hospital / Radiology
information system's Modality Worklist
including patient registration and study
information (optional) |
| | Disk Storage* | Hard-disk: 500 GB (or higher capacity)
enabling at least 15,000 image storage. | Hard-disk: 250 GB SSD (or higher
capacity) enabling at least 7,500 image
storage. Drive is used for temporary
storage only, and not for archive
purpose. From usability stand-point 7,500
images is much more than needed. |
| | Dimensions | 36 (H) x 18.3 (W) x 42 (L) cm
14.2" (H) x 7.2" (W) x 16.5" (L) | 27 (H) x 18.8 (W) x 2 (L)cm
10.6" (H) x 7.4" (W) x 0.8" (L) |
| | Weight | 10.1 Kg | 1.09 Kg |
| System | | Predicate
PrestoDR 4143 | ArtPix EZ2GO |
| Bucky | | Optional item, including grid and AEC | Provided by OEM. In stationary rooms only
(including grid and AEC). No electrical
connection to Artpix EZ2GO. |
| Power Distribution
Unit | | 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)) |
| | Line
Frequency | 50-60 Hz | 50-60 Hz |
| Digital System
Storage and
Transport | Temperature | -20 - 60°C | -20 - 60°C |
| | Relative
Humidity | 10 - 90% | 10 - 90% |
| | Atmospheric
Pressure | 70 - 106 kPa | 70 - 106 kPa |
| Regulatory Compliance | | IEC 60601-1-1, IEC 60601-1-2 (only when all
system's hardware supplied by Thales)
ISO 15223, IEC 60878, ISO 14971
Compliant with HIPAA requirements. | IEC 60601-1-1, IEC 60601-1-2 (only when all
system's hardware supplied by Thales)
ISO 15223, IEC 60878, ISO 14971
Compliant 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.
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K162224](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K162224)
**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).
**Cite:** Innolitics at https://innolitics.com