(48 days)
No
The summary mentions "digital techniques for image capture, display and manipulation" and "image processing system," but there is no mention of AI, ML, or related terms like deep learning or neural networks. The performance studies focus on standard medical device testing (electrical safety, EMC, software validation, cybersecurity, usability, biocompatibility) and comparison to predicate devices, without any indication of AI/ML-specific performance metrics or validation.
No
The device is used for taking diagnostic radiographic exposures, which means it aids in diagnosis rather than providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "for taking diagnostic radiographic exposures."
No
The device description explicitly states it is a "mobile x-ray system" consisting of hardware components like a mobile base unit, X-ray tube assembly, collimator, frame, and X-ray flat panel detector. While it includes an "image processing system," this is part of a larger hardware system.
Based on the provided information, the PLX5200A is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- PLX5200A Function: The PLX5200A is an X-ray system used for taking radiographic images of the body. It uses external radiation to create images, not tests on biological samples.
- Intended Use: The intended use clearly states it's for "taking diagnostic radiographic exposures," which is an imaging procedure, not an in vitro test.
- Device Description: The description details components of an X-ray system (X-ray tube, detector, etc.), not equipment for analyzing biological samples.
Therefore, the PLX5200A falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PLX5200A is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. It is not intended for mammography.
Product codes
IZL, MQB
Device Description
The proposed device is a mobile x-ray system, it uses digital techniques for image capture, display and manipulation and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging. This system consists of a mobile base unit, combined X-ray tube assembly, collimator, frame, X-ray flat panel detector, and image processing system, see figure V.1
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
qualified/trained doctor or technologist; mobile use in a ward, an operation room, etc. (bedside imaging)
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)
The following performance data were provided in support of the substantial equivalence determination. Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the proposed device. The system complies with IEC 60601-1:2005+A1:2012 / ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-3:2008+A1:2013, IEC 60601-2-54:2009 , IEC 62471 standard for safety, and and IEC 60601-1-2: 2014 standard for EMC, and Radio frequency (RF) wireless coexistence of equipment testing was performed according to IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence.
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The Embedded software and the workstation software for this device was considered as a "Moderate" level of concern, since a failure could result in minor injury to the patient or operator.
Cybersecurity documentation was provided according to Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
DICOM declaration was provided according to FDA recognized standard NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set.
Usability validation was performed and documentation was provided complies with FDA recognized standard IEC 60601-1-6 Edition 3.1 and EC 62366-1 Edition 1.0.
Risk management activities were performed throughout the time, and the documentations were provided according to FDA recognized standard ISO 14971 Second edition 2007-03-01 Medical devices - Application of risk management to medical devices.
The biocompatibility evaluation for the proposed device was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The biocompatibility testing for the x-ray flat panel detector includes the following tests: Cytotoxicity, Skin Sensitization, Skin irritation.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
August 25, 2021
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue.
Nanjing Perlove Medical Equipment Co., Ltd. % Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road 555 Shanghai, 200071 CHINA
Re: K212134
Trade/Device Name: Diagnostic X-ray System/PLX5200A Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL. MOB Dated: June 15, 2021 Received: July 8, 2021
Dear Stuart Situ:
We have reviewed vour 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
1
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 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,
Laurel M.
Burk -S
Digitally signed by Laurel M. Burk -S Date: 2021.08.25 09:52:14 -04'00'
、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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212134
Device Name Diagnostic X-ray System PLX5200A
Indications for Use (Describe)
The PLX5200A is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. It is not intended for mammography.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
K212134
l Submitter
Nanjing Perlove Medical Equipment Co., Ltd. No.97&99, Wangxi Road, Jiangning District, Nanjing 211100, Jiangsu, China
Contact person:
Lu Fengfang Position: QC Manager Tel.: +86-025-68571666 E-mail: ce@perlove.com.cn Preparation date: Aug 10, 2021
II Proposed Device
| Trade Name of Device: | Diagnostic X-ray System PLX5200A |
|---|---|
| Models: | PLX5200A |
| Regulation name: | Mobile X-Ray System |
| Regulation Number: | 21 CFR 892.1720 |
| Regulatory Class: | Class II |
| Product code: | IZL, MQB, |
| Review Panel | Radiology |
III Predicate Devices
- 510(k) Number: K192011 a. Product Code: IZL, MQB Classification: 21 CFR 892.1720 Trade/Device Name: PhoeniX Manufacturer: SEDECAL SA Regulation Name: Mobile x-ray system Regulatory Class: Class II
- 510(k) Number: K201340 b. Product Code: IZL, MQB Classification: 21 CFR 892.1720 Trade/Device Name: AQUILA 320 D / AQUILA 320 S Manufacturer: VMI Tecnologias LTDA
4
Regulation Name: Mobile x-ray system Regulatory Class: Class II
IV Reference Devices
- 510(k) Number: K150929 a. Product Code: MQB Regulation Name: Stationary x-ray system Regulatory Class: II Classification: 21 CFR 892.1680 Trade/Device Name: CareView 1500Cw X-Ray Flat Panel Detectors Manufacturer: CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
- 510(k) Number: K201004 b. Product Code: MQB Regulation Name: Stationary x-ray system Regulatory Class: Class II Classification: 21 CFR 892.1680 Trade Name: Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI Manufacturer: IRay Technology Taicang Ltd.
V Device description
The proposed device is a mobile x-ray system, it uses digital techniques for image capture, display and manipulation and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging. This system consists of a mobile base unit, combined X-ray tube assembly, collimator, frame, X-ray flat panel detector, and image processing system, see figure V.1
Image /page/4/Figure/7 description: The image shows a mobile X-ray machine with several labeled components. The X-ray tube assembly and collimator are located at the top right of the machine. The image processing system is labeled on the left side of the machine, and the detector is located at the bottom left.
Figure V.1 Picture Illustration of PLX5200A
5
Principles of Operation
X-rays are produced by the x-ray tube (an evacuated tube with an anode and a cathode) when a stream of electrons, accelerated to high velocities by a high-voltage, collides with the tube's target anode. Collimator confines the primary beam to the approximate size and shape that will cover only the area of diagnostic interest. The device is equipped with wireless x-ray flat panel detectors, which use a scintillator material to convert x-rays to visible light. An array of photodiodes on the scintillator layer absorbs the light and translates it into a signal for digital display.
PLX5200A is used for moving to a ward, an operation room, etc., and photographing the patient who is not suitable for moving.
PLX5200Ais configured with a 150kHu x-ray tube, a manual collimator, and small, light, wireless, easy handling portable DR detectors: CareView 1500Cw, and Mars1417V-TSI (both are FDA cleared) with capacity of wireless image capture and transmission technology. The wheeled image process system integrates the touch screen image acquisition computer with workstation software installed, and 50kw high frequency generator with micro-processor controls.
Software
The software of the Mobile Digital Radiography System includes an embedded software and a workstation software. The embedded software in the diagnostic system intended to control X-rays generation for examination of various anatomical regions. The workstation software is installed in the computer or tablet to complete the image data acquisition, image display, image processing, film printing, reporting, image transmission and other clinical work, such as registering patients' information, acquiring images, viewing images, writing and printing diagnostic report, DICOM file sending, DICOM film printing, database backup and restore, etc, which provide an effective means to manage medical image information for hospitals.
The level concern of the software of this device is Moderate.
VI Indication for use
The PLX5200A Mobile X-ray system is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions.
It is not intended for mammography.
6
VII Comparison of technological characteristics with the predicate devices
The comparison between the overall specifications of the predicate devices and the proposed device (PLX5200A) is shown in Table 1. Any differences between the predicate and subject devices have no impact on safety or effectiveness of the subject devices and do not raise any potential safety risks.
| Item | Proposed device | Predicate device 1
(K192011) | Predicate device 2
(K201340) | Discussion |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Model name | PLX5200A | Phoenix | AQUILA 320 D / AQUILA
320 S | - |
| Product
Code | IZL, MQB, | IZL, MQB | IZL, MQB | same |
| Regulation
No. | 21 CFR 892.1720 | 21 CFR 892.1720 | 21 CFR 892.1720 | same |
| Class | Class II | Class II | Class II | same |
| Indication for
use | The PLX 5200A Mobile X-
ray system is intended for
use by a qualified/trained
doctor or technologist on
both adult and pediatric
patients for taking diagnostic
radiographic exposures of
the skull, spinal column,
chest, abdomen, extremities,
and other body parts.
Applications can be
performed with patient
sitting, standing or lying in
the prone or supine
positions.
It is not intended for
mammography. | Intended for use by a
qualified/trained doctor or
technician on both adult and
pediatric subjects for taking
diagnostic radiographic
exposures of the skull,
spinal column, chest,
abdomen, extremities, and
other body parts.
Applications can be
performed with the patient
sitting, standing, or lying in
the prone or supine position.
Not for mammography | Intended for use by a
qualified/trained doctor or
technician on both adult
and pediatric subjects for
taking diagnostic
radiographic exposures
of the skull, spinal
column, chest, abdomen,
extremities, and other
body parts. Applications
can be performed with
the patient sitting,
standing, or lying in the
prone or supine position.
Not for mammography | same |
| X-ray
generator
rating | 50 kW | 20 kW, 32 kW, 40 kW and
50 kW. | 35.2 kW only | |
| | | | | Same with
Phoenix's
max rating. |
| X-ray voltage
range | 40-150kV in 1 kV steps | From 40 kV to 150 kV in 1
kV steps | From 40 to 125 kV in 1
kV steps | same with
Phoenix. |
| mARange | 10500mA | From 10 mA to 630 mA / 640, 50/60Hz
mA /650 mA. | From 20 to 320 mA | similar |
| X-ray Tube | 0.6/1.2, 150kv max; | E7886
0.7/1.3, 150kv max.
XRR-3331:
0.6/1.2, 150kv max | Unknown | Similar
The same
with one of
Phoenix's
tube. |
| Collimator | X5300:
Manually, with added
filtration 1.0mmAl/2.0mmAl;
Inherent filtration: 1.5mmAl | Ralco R108F (Two versions,
see details in PHOTOS item
in K192011 summary.)
Manually.
Parameters are unknown | Choice of Models
Leadmec Collimator –
LDM206
Ralco Collimator - R104
Ralco Collimator –
R104/A
Ralco Collimator - R108
SM Collimator – 38A
Parameters are unknown
All collimators meet the
US Performance
Standard | Different |
| Collimator
operation
method | Manually adjustable
collimator | Manually | Unknown | Same with
Phoenix. |
| Pixel pitch | CareView 1500Cw: 154 µm
Mars1417V-TSI: 150 µm | 125um | Pixel pitches from 120 to
154µm | similar |
| Effective
reception
field | 14 in. x 17 in; | 17 in. x 17 in;
14 in. x 17 in;
Or 11in×14in; | 43x43cm, 35x43cm or
24x30cm | Same with
Phoenix's
one option. |
| Spatial
resolution | Min 3.3lp/mm; | unknown | Min 3.3lp/mm; | Same with
AQUILA
320 D /
AQUILA
320 S |
| Software | PLX5200 workstation
software
5200 Embedded Software | Canon control software
CXDI-NE | DROC Software for
Careray Detectors,
(K201058 and others)
ECONSOLE Software for
DRTECH Detectors.
K152172 | Different |
| Power
Source | 230V
110V~, 60Hz
And battery. | Universal power supply,
from 100 V~ to 240
V~. 1 phase, 1.1 kVA | 110/115/127/220/230
VCA-50/60 Hz and
Batteries | similar |
| Meets US
Performance
Standard | YES 21 CFR 1020.30 and
1020.31 | YES 21 CFR 1020.30
and 1020.31 | YES 21 CFR 1020.30
and 1020.31 | same |
| Panel
Interface | Ethernet or Wi-Fi wireless | Ethernet or Wi-Fi wireless | Ethernet or Wi-Fi
wireless | same |
7
8
The differences between the proposed device and the predicate device are the collimator and the software. The proposed device collimator (X5300) was tested with the system according to FDA
9
recognized standards ANSI/AAMI ES60601-1, IEC60601-1-3 and IEC 60601-2-54. The proposed software: PLX5200 workstation software and 5200 Embedded Software were validated and comply with FDA recognized standard IEC 62304.
The results of non-clinical bench performance testing indicate that the proposed deviceare as safe and effective as the predicate devices.
VIII Performance Data
The following performance data were provided in support of the substantial equivalence determination. Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the proposed device. The system complies with IEC 60601-1:2005+A1:2012 / ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-3:2008+A1:2013, IEC 60601-2-54:2009 , IEC 62471 standard for safety, and and IEC 60601-1-2: 2014 standard for EMC, and Radio frequency (RF) wireless coexistence of equipment testing was performed according to IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence.
Software
- Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The Embedded software and the workstation software for this device was considered as a "Moderate" level of concern, since a failure could result in minor injury to the patient or operator.
Cybersecurity
The cybersecurity documentation was provided according to Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
- DICOM
DICOM declaration was provided according to FDA recognized standard NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set.
Usability Testing
Usability validation was performed and documentation was provided complies with FDA recognized standard IEC 60601-1-6 Edition 3.1 and EC 62366-1 Edition 1.0.
Risk management
10
Risk management activities were performed throughout the time, and the documentations were provided according to FDA recognized standard ISO 14971 Second edition 2007-03-01 Medical devices - Application of risk management to medical devices.
Biocompatibility Testing
The biocompatibility evaluation for the proposed device was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The biocompatibility testing for the x-ray flat panel detector includes the following tests:
- . Cytotoxicity
- . Skin Sensitization
- Skin irritation
IX Clinical Testing
No clinical study is included in this submission.
X Conclusion
The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate device.