(170 days)
Not Found.
No
The document describes a standard X-ray system with microprocessors for control and user interface, and a digital variant with a flat panel detector and console. There is no mention of AI, ML, or any advanced image processing or analysis features that would typically indicate the use of such technologies. The performance studies section also relies on predicate device comparisons and detector clearance rather than AI/ML specific validation.
No
The device is described as generating radiographic images for diagnostic purposes, not for therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section states that the devices are "intended for use in generating radiographic images of human anatomy in all general-purpose x-ray diagnostic procedures." The "Device Description" also mentions that the systems generate X-rays "for diagnostic radiography."
No
The device description explicitly states that SKANMOBILE and SKANMOBILE-DR are X-ray systems consisting of hardware components like a tube head, trolley, operator console, and brake mechanism, in addition to software/firmware.
Based on the provided information, the SKANMOBILE and SKANMOBILE-DR devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly states that the devices are for generating radiographic images of human anatomy for diagnostic procedures. This involves imaging the internal structures of the body using X-rays.
- Device Description: The description details an X-ray system that produces X-rays and captures images. It does not mention any components or processes related to testing biological samples (like blood, urine, tissue, etc.) outside of the body, which is the hallmark of an IVD.
- Anatomical Site: The devices are used to image various parts of the human body directly.
- Input Imaging Modality: The input is X-ray, which is an imaging modality, not a method for analyzing biological samples.
In Vitro Diagnostics (IVDs) are medical devices that are used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to provide information for diagnosis, monitoring, or screening. The SKANMOBILE and SKANMOBILE-DR do not perform this function. They are imaging devices used for diagnostic purposes based on the visual interpretation of radiographic images.
N/A
Intended Use / Indications for Use
SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals.
SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist.
SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications.
Product codes (comma separated list FDA assigned to the subject device)
IZL, MQB
Device Description
The SKANMOBILE and SKANMOBILE-DR are X-ray systems which generates high frequency X-rays for diagnostic radiography in all patient population including pediatrics and adults.
SKANMOBILE houses two microprocessors: one for control/supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output.
SKANMOBILE consists of following sub-assemblies:
-
- Tube head
-
- SKANMOBILE trolley
SKANMOBILE-DR is a variant based on SKANMOBILE platform. SKANMOBILE-DR is a digital radiographic system designed for optimized image quality featuring wireless flat panel detector and operator console for digital imaging integrated with high frequency generator. SKANMOBILE-DR is similar to SKANMOBILE where tube head generator, collimator, and counter balancing mechanism remains same. The new or modified assemblies/sub-assemblies that are used in SKANMOBILE-DR are as follows:
-
- Touchscreen operator console.
-
- Modified brake mechanism for wheels
-
- Modified cassette tray to house the cassette / flat panel detectors.
Both SKANMOBILE and SKANMOBILE-DR consists of software/firmware which enables the operation of the devices. The design and development of the software has been executed as per the requirements of ISO 62304. User interface is provided via UART interface from Console System. Software Control System of Control Firmware is of Master – Slave in nature. The programming language adopted is ANSI C and the software architecture follows a simple Call and Return flow of statements and modules.
The device is packaged inside a corrugated box with, appropriate labels and the user manual after cleaning the entire unit. The device is secured to the wooden pallet and covered for adequate safety.
The device is packed appropriately as required by the mode of transportation.
Mentions image processing
Yes, "image processing software" is mentioned.
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
all patient population including paediatrics and adults
Intended User / Care Setting
trained & qualified physicians or x-ray technologist.
radiology departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals.
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)
Nonclinical data is sufficient to support the safety and performance of SKANMOBILE and SKANMOBILE DR. Hence clinical studies are not required.
Summary of results:
- IEC 60601-1:2005+AMD1:2012 (Edition 3.1) Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General ● requirements for basic safety Collateral standard: Electromagnetic compatibility requirements and tests
- IEC 60601-1-3:2008 (Edition 2) General requirements for basic safety and ● essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-2-54:2018 Particular requirements for the basic safety and ● essential performance of X-ray equipment for radiography and radioscopy
- IEC 60601-2-28:2010 Medical electrical equipment Part 2-28: Particular ● requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- IEC 60601-1-6:2010/AMD1:2013 Medical electrical equipment Part 1-6: ● General requirements for basic safety and essential performance - Collateral standard: Usabilitv
- . IEC 62366:2007/AMD 1:2014 Medical devices — Application of usability engineering to medical devices
- IEC 62304:2006 Medical device software Software life cycle processes ●
- ISO 14971:2012 Medical devices. Application of risk management to medical devices.
- IEC 62494-1 Edition 1.0 (2008-08) Medical electrical equipment Exposure ● index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography.
- IEC 62220-1-1 Edition 1.0 2015-03 Medical electrical equipment-● Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging.
- NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set.
- IEC 61910-1 Edition 1.0 2014-09 Medical electrical equipment Radiation ● dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy.
- . IEC 60336 Fourth edition 2005-04 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots [Including: Technical Corrigendum 1 (2006)]
- IEC 60522:1999: B: 2003 Medical electrical equipment Diagnostics X-rays -● Part 1: Determination of quality equivalent filtration and permanent filtration.
- . ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- . EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices.
- ISO 15223-1 Third Edition 2016-11-01 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements.
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s)
AMADEO M-DR mini, AMADEO M-AX mini (K182317), DRAGON X SPSL4HC; DRAGON X SPSL8HC (K173299)
Reference Device(s)
Not Found.
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
March 4, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Skanray Technologies Limited % Ankur Naik Managing Director IZiel Healthcare 14, Hadapsar Industrial Estate, Hadapsar Pune, Maharashtra 411013 INDIA
Re: K212940
Trade/Device Name: SKANMOBILE, SKANMOBILE-DR Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB Dated: January 12, 2022 Received: January 18, 2022
Dear Ankur Naik:
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
1
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 (OS) 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 Burk Assistant Director Diagnostic X-ray Systems Team 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
2
Indications for Use
510(k) Number (if known) K212940
Device Name SKANMOBILE and SKANMOBILE-DR
Indications for Use (Describe)
SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals.
SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist.
SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications.
Type of Use (Select one or both, as applicable)
| ☒ Remediation Use (Part 264 CFR 90 Subpart D) | ☐ Gas Treatment Use (264 CFR 90 Subpart O) |
|---|---|
| ------------------------------------------------------------------------------------------------ | -------------------------------------------- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Attachment 2-1: 005_510(k) Summary
4
510(k) Summary - K212940
510(k) summary of safety and effectiveness for SKANMOBILE and SKANMOBILE-DR is provided in accordance with 21 CFR 807.92.
| Date: | 12 January 2022 |
|---|---|
| Submitter (Owner): | Vasundhara R |
| Regulatory Head | |
| Skanray Technologies Limited | |
| Plot# 15-17, Hebbal Industrial Area, Hebbal | |
| Mysore, Karnataka 570016, India | |
| P: +91 821 2415559 | |
| Email: vasundhara.r@skanray.com | |
| 510(k) Contact | |
| Person: | Ankur Naik |
| Managing Director | |
| IZiel Healthcare | |
| 14, Hadapsar Industrial Estate, | |
| Hadapsar, Pune – 411013, India. | |
| P: +91 72762 2555 M: +91 7069553814 | |
| Email: ankur.naik@izielhealthcare.com | |
| Device Trade Name: | SKANMOBILE |
| SKANMOBILE-DR | |
| Regulation Number: | 892.1720 |
| Regulation Name: | Mobile X-Ray System |
| Regulation | |
| Description: | 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 support, component parts, and | |
| accessories. | |
| Review Panel: | Radiology |
| Device Class: | Class II |
| Product Code: | IZL |
| MQB | |
| Predicate Device(s): | ● AMADEO M-DR mini, AMADEO M-AX mini (K182317) |
| Regulation number: 892.1720 | |
| Regulation name: Mobile X-Ray system | |
| Device class: II | |
| Product code: IZL, MQB | |
| Review Panel: Radiology | |
| • DRAGON X SPSL4HC; DRAGON X SPSL8HC (K173299) | |
| Regulation number: 892.1720 | |
| Regulation name: Mobile X-Ray system | |
| Device Class: II | |
| Product code: IZL, MQB | |
| Review Panel: Radiology |
5
Device description
The SKANMOBILE and SKANMOBILE-DR are X-ray systems which generates high frequency X-rays for diagnostic radiography in all patient population including pediatrics and adults.
Device variants
The following table lists the details of the variants of SKANMOBILE and SKANMOBILE-DR:
Table 1: List of Device Variants
| Product Name | Part # |
|---|---|
| SKANMOBILE - HF diagnostic X-ray system, 230 VAC | 303-000018-0 |
| SKANMOBILE - HF diagnostic X-ray system, 110 VAC | 303-000018-3 |
| SKANMOBILE-DR – HF diagnostic X-Ray system, 230 VAC | 303-000018-15 |
| SKANMOBILE-DR – HF diagnostic X-Ray system, 110 VAC | 303-000018-16 |
Device design
SKANMOBILE houses two microprocessors: one for control/supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output.
SKANMOBILE consists of following sub-assemblies:
-
- Tube head
-
- SKANMOBILE trolley
SKANMOBILE-DR is a variant based on SKANMOBILE platform. SKANMOBILE-DR is a digital radiographic system designed for optimized image quality featuring wireless flat panel detector and operator console for digital imaging integrated with high frequency generator. SKANMOBILE-DR is similar to SKANMOBILE where tube head generator, collimator, and counter balancing mechanism remains same. The new or modified assemblies/sub-assemblies that are used in SKANMOBILE-DR are as follows:
6
-
- Touchscreen operator console.
-
- Modified brake mechanism for wheels
-
- Modified cassette tray to house the cassette / flat panel detectors.
Both SKANMOBILE and SKANMOBILE-DR consists of software/firmware which enables the operation of the devices. The design and development of the software has been executed as per the requirements of ISO 62304. User interface is provided via UART interface from Console System. Software Control System of Control Firmware is of Master – Slave in nature. The programming language adopted is ANSI C and the software architecture follows a simple Call and Return flow of statements and modules.
Flat panel detectors and image acquisition software integration details
Table 2 explains the compatibility between available options of flat panel detectors and image acquisition software used in the X-ray systems.
| Flat Panel Detector | Image Acquisition
Software | Remarks |
|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CE certified / FDA
cleared Compatible Flat
Panel Detector Varex
Paxscan 4336Wv4 can
be used with the X-Ray
system | FDA cleared Image
Acquisition System with
compatible Flat Panel
Detector can be used. | SKANMOBILE-DR is
verified and validated with
Varex Flat Panel Detector
Paxscan 4336Wv4 and
ECOM Image Acquisition
Software with customized
OEM title |
| CE certified / FDA
cleared Compatible Flat
Panel Detector CareView
1500P can be used with
the X-ray system | FDA cleared Image
Acquisition System with
compatible Flat Panel
Detector can be used. | SKANMOBILE-DR is
verified and validated with
CareView 1500P detector
and ECOM Image
Acquisition Software with
customized OEM title |
Table 2: Flat panel detectors and image acquisition software integration
The above-mentioned specific combinations of flat panel detectors and image acquisition software are compatible with all types/configurations of other components (x-ray generator, x-ray tube, collimator, and mechanicals).
The device is packaged inside a corrugated box with, appropriate labels and the user manual after cleaning the entire unit. The device is secured to the wooden pallet and covered for adequate safety.
The device is packed appropriately as required by the mode of transportation.
Intended Use / Indications for Use
SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology
7
departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals.
SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting, standing or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist.
SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications.
Comparison to predicate devices
Two predicate devices are selected in this submission for the SKANMOBILE and SKANMOBILE-DR.
Predicate device 1: AMADEO M-DR mini, AMADEO M-AX mini (K182317)
Predicate device 2: DRAGON X SPSL4HC; DRAGON X SPSL8HC (K173299)
The details of the substantial equivalence between the subject device and predicate devices are explained in Table 3:
8
Table 3: Comparison to Predicate Devices
| Comparable
Properties | Subject Device | Predicate Device 1
(K182317) | Predicate Device 2
(K173299) | Comparison Results |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
name | SKANMOBILE and
SKANMOBILE-DR | AMADEO M-DR mini,
AMADEO M-AX mini | DRAGON X SPSL4HC;
DRAGON X SPSL8HC | Not applicable |
| Manufacturer | Skanray Technologies Limited | Oehm Und Rehbein
Gmbh | Sedecal SA | Not applicable |
| Regulation
number | 892.1720 | 892.1720 | 892.1720 | Identical |
| Product code | IZL, MQB | IZL, MQB | IZL, MQB | Identical |
| Product
Class | II | II | II | Identical |
| Comparable
Properties | Subject Device | Predicate Device 1
(K182317) | Predicate Device 2
(K173299) | Comparison Results |
| Intended Use
/ Indications
for Use | SKANMOBILE and
SKANMOBILE-DR are
intended for use in generating
radio graphic images of human
anatomy in all general-purpose
x-ray diagnostic procedures for
all patient population including
paediatrics and adults. It may
be used in radiology
departments, emergency
rooms, intensive care units,
operating rooms, orthopaedics
clinics, military camps,
paediatric clinics, medical
camps and small hospitals.
SKANMOBILE and
SKANMOBILE-DR are
indicated for taking
radiographic exposures of the
skull, spinal column, chest,
abdomen, extremities and
other body parts with the
patient sitting, standing or lying
in the prone or supine position.
The device has been designed
for indoor usage and
used/operated only by the
trained & qualified physicians
or x-ray technologist.
SKANMOBILE and
SKANMOBILE-DR are not
intended for mammographic
applications. | These Portable
Diagnostic
Radiographic
Systems are 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). | These Portable
Diagnostic
Radiographic
Systems are 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). | Substantially Equivalent |
| Comparable
Properties | Subject Device | Predicate Device 1
(K182317) | Predicate Device 2
(K173299) | Comparison Results |
| Line power
requirements | 230 VAC / 110 VAC | 100-240 VAC | 100-240 VAC / 220 -
240 VAC | Substantially Equivalent
Mains power voltage
range are country specific.
Devices are designed to
accept either
230VAC/220VAC or
100VAC/110VAC,
depending on where they
are placed. The mains
input labelling will be
declared to indicate the
device compliance to the
mains input meeting
specified country mains
regulation and hence does
not raise the level of
safety concern and affect
performance. |
| Generator
type | High Frequency | High frequency | High frequency | Identical |
| Comparable
Properties | Subject Device | Predicate Device 1
(K182317) | Predicate Device 2
(K173299) | Comparison Results |
| Generator
power level | 4 KW | 5KW | 4KW, 8KW | Substantially equivalent
Maximum generator
power is the maximum
power derived from the
maximum kV and mA
drawn. The device
generates kV and mA
optimal for the different
anatomy as defined by the
accepted anatomically
programmed radiography
(APR) table, which are
independent of power
drawn by the system.
Thus, minor difference in
the power does not
change the intended
application. Additionally,
electrical safety and EMC
testing has been
performed on the subject
devices and it has been
observed that the device
performs as intended and
hence does not raise the
level of safety concern
and affect performance. |
| Comparable
Properties | Subject Device | Predicate Device 1
(K182317) | Predicate Device 2
(K173299) | Comparison Results |
| Peak voltage | 100 kV | 110 kV | 125 kV | Substantially equivalent
Minor difference in the
peak voltage applied
across the x-ray tube
indicates differences in the
device construction and
the object distance from
the source. However,
these changes do not
change the intended
device application. The
quality of the images
obtained from the subject
devices were analysed by
a radiographer and a
radiologist and it was
found the images were of
good quality which were
easily read by the
radiologist and hence
does not raise the level of
safety concern and affect
performance. |
| Comparable
Properties | Subject Device | Predicate Device 1
(K182317) | Predicate Device 2
(K173299) | Comparison Results |
| High voltage range | 40 kV–100 kV, 1 kV step | 40-100 kV, 1 kV step | 40-125 kV, 1 kV step | Substantially equivalent
X-ray tube voltage setting
range is 40kV to maximum
peak X-ray voltage, which
the tube can handle.
Range is a minor element,
which can be different but
it still maintains the same
intended application and
hence does not raise the
level of safety concern
and affect performance. |
| mAs range | 0.1 mAs to 250 mAs | 0.4 –100 mAs | 0.1 mAs to 250 mAs | Substantially equivalent
Product of X-ray tube
current and time is termed
as mAs, which is a
dependent parameter of
power rating and voltage
rating which as mentioned
above does not change
the intended application.
APR table recommends
the user to use referred
value or user can set a
value which is appropriate
for that examination. It
does not raise the level of
safety concern and affect
performance. |
| Comparable
Properties | Subject Device | Predicate Device 1
(K182317) | Predicate Device 2
(K173299) | Comparison Results |
| Collimator | Manually operated, LED light
source, Maximum light field of
48 X 48 cm at 1 m SID, 30 Sec
timer. | POSKOM PCMAX-
100CAH: LED lamp,
Maximum light field of
47 X 47 cm @ 100 cm
SID, 30 Sec timer. | Ralco R72S:
Manual, white LED,
Single layer square
field of 43 X 43 cm at
100 cm SID, 125 kVp.
(K030487) | Substantially equivalent
Collimator is the device
which restricts the X-ray
beam within the specified
useful area avoiding
unintended radiation on
the body. Different light
field indicates the area of
detector that can be used
with the system and does
|
| Comparable
Properties | Subject Device | Predicate Device 1
(K182317) | Predicate Device 2
(K173299) | Comparison Results |
| Image
Receptor | DR | DR | DR | Substantially Equivalent
SKANMOBILE variant
supports image reception
through film /computed
radiography (CR)/digital
radiography (DR)
technologies and user can
use any of these image
reception technologies
which can integrate with
SKANMOBILE with the
software inbuilt in the
image receptors.
SKANMOBILE-DR variant
supports DR with its own
customized Skanview
software. |
| Digital Panel
Models and
their
Clearance
Numbers | Nexus DR™ Digital X-ray
Imaging System with PaxScan
4336Wv4 (K161459)
CareView 1500P X-ray Flat
Panel Detectors (K162178) | PerkinElmer XRpad2
4336 detector
(K161966) or
the XenOR 35CW
(CareRay
CareView1500CW)
(K150929) | Toshiba FDX3543RP
or
FDX3543RPW
(K130883) | Substantially Equivalent
The subject device utilizes
a different X-ray flat panel
detector; however, the flat
panel detectors used by
the subject device are
already previously cleared
by the FDA and the testing
demonstrates that it does
not raise the level of
safety concern and affect
performance. |
| Comparable
Properties | Subject Device | Predicate Device 1
(K182317) | Predicate Device 2
(K173299) | Comparison Results |
| Digital Panel
Specifications | PaxScan® 4336Wv4: Pixel
pitch: 139 μm
Detector Element Matrix: 3072
x 2560
CareView 1500P:
Pixel pitch 154 μm
Image Matrix Size: 2304 x
2816 pixels | XRpad2 4336: 100 μ,
3524 × 4288 pixels
XenOR 35CW
(CareView1500CW):
154 μ 2304 x 2816
pixels | FDX3543RP: 143 μm
pixel pitch, 2448 ×2984
pixels
FDX3543RPW: 140 μ,
2466 ×3040
pixels | Substantially Equivalent
The resolution of the
number of horizontal and
vertical sensing element
on the detector and
difference in the size does
not change the intended
application. This
parameter is defined
under the limited spatial
resolution or detectable
size of anatomy. Spatial
resolution for general
radiography is generalized
at 1.6 lp/mm. This does
not raise the level of
safety concern and affect
performance. |
| Detector
Technology | Direct Deposition CsI | Direct Deposition CsI | Direct Deposition CsI | Identical |
| Detective
Quantum
Efficiency
(DQE) of
Digital Panel | Paxscan 4336Wv4:
0.242 @ 1cycle/mm
0.125 @ 2cycles/mm
0.04 @ 3cycles/mm
CareView1500P (@RQA5,
30μGy):
~ 65% @ (0 lp/mm)
~ 20% @ (3 lp/mm) | XRpad2 4336:
75% (0 cy/mm)
60% (1 cy/mm)
40% (3 cy/mm)
CareView1500CW:
~ 65% @ (0 lp/mm)
~ 20% @ (3 lp/mm) | FDX3543RP: >70%
FDX3543RPW: >70%
@ 0 lp/mm | Substantially Equivalent
The performance of the
flat panel detectors with
respect to the claimed
DQE was evaluated and it
was demonstrated that the
DQE values measured
were comparable to the
values claimed by the
detector manufacturer.
This does not raise the
level of safety concern
and affect performance. |
| Comparable
Properties | Subject Device | Predicate Device 1
(K182317) | Predicate Device 2
(K173299) | Comparison Results |
| Modulation
Transfer
Function
(MTF) of
Digital Panel | Paxscan 4336Wv4:
0.521 @ 1cycle/mm
0.206 @ 2cycles/mm
0.08 @ 3cycles/mm
CareView1500P:
~ 70 % @ (1 lp/mm)
~ 40% (@ 2 lp/mm)
~ 22% (@ 3 lp/mm) | XRpad2 4336:
70% (1 cy/mm)
40% (2 cy/mm)
15% (4 cy/mm)
CareView1500CW:
~ 70 % @ (1 lp/mm)
~ 40% (@ 2 lp/mm)
~ 22% (@ 3 lp/mm) | FDX3543RP: 36% typ.
(2.0 lp/mm, 70kVp,
1x1)
FDX3543RPW:
Unknown | Substantially Equivalent
The performance of the
flat panel detectors with
respect to the claimed
MTF was evaluated and it
was demonstrated that the
MTF values measured
were comparable to the
values claimed by the
detector manufacturer.
This does not raise the
level of safety concern
and affect performance. |
| Communicati
on interface | Wireless Data Interface: Dual
Band (2.4GHz and/or
5GHz) 802.11a/b/g/n/ac | Gb Ethernet or
802.11n WiFi | Unknown | Identical |
| Focal spot | 1.8 mm | 1.8 mm | 0.5 – 1.8 mm, 0.6 – 2.8
mm | Identical |
9
10
11
12
13
14
15
16
17
18
| Comparable
Properties | Subject Device | Predicate Device 1
(K182317) | Predicate Device 2
(K173299) | Comparison Results |
|---------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software | Customized
E-COM Software called
SkanView, a digital
radiography operational
software | DICOMPACS DX-R | ECOM software as
cleared in K130883 | Substantially Equivalent
SKANMOBILE and
SKANMOBILE-DR utilizes
customized E-COM
software. The E-COM
software is 510(k) cleared
in K193644. The
customization of the
510(k) cleared software
has been validated and
documented as part of
software validation &
verification. It has been
demonstrated that the
customization of the E-
COM software does not
raise the any new
questions of safety or
performance. |
| Comparable
Properties | Subject Device | Predicate Device 1
(K182317) | Predicate Device 2
(K173299) | Comparison Results |
| Connection | Wi-Fi | Ethernet or Wi-Fi | Ethernet or Wi-Fi | Substantially Equivalent
Ethernet and Wi-fi are the
connectivity modules with
external devices for the
transmission of data.
Ethernet needs cable
connectivity for data
transfer whereas Wi-fi is
wireless data transfer (no
cable is required). Both
have the same
functionality of data
transmission. This does
not raise the level of
safety concern and affect
performance. |
| DICOM | Yes | Yes | Yes | Identical |
| Power
source | AC line | AC line | AC line | Identical |
| Performance
Standard | 21 CFR 1020.30 and 1020.31 | 21 CFR 1020.30 | 21 CFR 1020.30 | Substantially Equivalent
In addition to 21 CFR
1020.30, subject device
also shows compliance to
21 CFR 1020.31 and the
test report is available in
Section 18 (Att-18-9). |
| Electrical
safety and
EMC | IEC-60601
IEC-60601-1-2
IEC-60601-1-3
IEC-60601-1-28
IEC-60601-2-54 | IEC-60601
IEC-60601-1-2
IEC-60601-1-3
IEC-60601-2-54 | IEC-60601 IEC-60601-
1-2
IEC-60601-1-3
IEC-60601-2-54 | Identical |
19
20
Discussion of similarities and differences
SKANMOBILE and SKANMOBILE-DR is intended for generating radiographic images of human anatomy for all general-purpose X-Ray diagnostic procedures in all patient population including pediatrics and adults. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The device shall be used or operated only by the trained & qualified physicians or X-ray technologists. This device is not intended for Mammography application. This device utilizes FDA cleared X-ray flat panel detectors and image processing software which are the associated components of any digital X-Ray diagnostic system. The other components of the imaging system such as the X-Ray generator and X-Ray tube are either identical or similar to the predicate devices. The remaining other components have no impact on the safety and performance of the system. In addition, the subject device confirms to the following performance standards as summarized below.
Performance data
SKANMOBILE and SKANMOBILE-DR are developed by implementing various design control activities including design verification, design validation and risk analvsis.
The risks identified during risk analysis were reduced by applying suitable risk control measures and it was noted that there were no unacceptable risks remained after applying risk control measures. Though the X-Ray is harmful to the patient or user during intended use, the clinical benefit in terms of image quiding for diagnosis and treatment outweighs the risk caused by X-ray. The device is intended to be used in hospitals and clinics by trained operators.
Design verification and validation activities have been carried both in-house and by outsourcing to appropriate third-party vendors. A summary of the design verification, design validation and performance testing activities is elaborated in section 18 of this submission.
The SKANMOBILE and SKANMOBILE-DR comply with following standards:
- IEC 60601-1:2005+AMD1:2012 (Edition 3.1) Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General ● requirements for basic safety Collateral standard: Electromagnetic compatibility requirements and tests
- IEC 60601-1-3:2008 (Edition 2) General requirements for basic safety and ● essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-2-54:2018 Particular requirements for the basic safety and ● essential performance of X-ray equipment for radiography and radioscopy
- IEC 60601-2-28:2010 Medical electrical equipment Part 2-28: Particular ● requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
21
- IEC 60601-1-6:2010/AMD1:2013 Medical electrical equipment Part 1-6: ● General requirements for basic safety and essential performance - Collateral standard: Usabilitv
- . IEC 62366:2007/AMD 1:2014 Medical devices — Application of usability engineering to medical devices
- IEC 62304:2006 Medical device software Software life cycle processes ●
- ISO 14971:2012 Medical devices. Application of risk management to medical devices.
- IEC 62494-1 Edition 1.0 (2008-08) Medical electrical equipment Exposure ● index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography.
- IEC 62220-1-1 Edition 1.0 2015-03 Medical electrical equipment-● Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging.
- NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set.
- IEC 61910-1 Edition 1.0 2014-09 Medical electrical equipment Radiation ● dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy.
- . IEC 60336 Fourth edition 2005-04 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots [Including: Technical Corrigendum 1 (2006)]
- IEC 60522:1999: B: 2003 Medical electrical equipment Diagnostics X-rays -● Part 1: Determination of quality equivalent filtration and permanent filtration.
- . ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- . EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices.
- ISO 15223-1 Third Edition 2016-11-01 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements.
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems.
Summary of clinical testing
As per FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices document, subject device does not have major modifications when compared to predicate devices. Additionally, the flat panel detector used in the subject device has been previously cleared by US FDA. Considering this, nonclinical data is sufficient to support the safety and performance of SKANMOBILE and SKANMOBILE DR. Hence clinical studies are not required.
22
Conclusion
Technological differences from the predicate devices include different detectors. Although some of the components differ from the predicate devices, the subject device utilizes previously cleared X-ray flat panel detectors and image processing software. The other components of the imaging system such as the X-ray generator and X-ray tube are either identical or similar to the predicate devices. Despite the few differences, after analysis of all test information, including the indications for use and test data it is collectively demonstrated that the SKANMOBILE and SKANMOBILE-DR are as safe and effective as the predicate devices when used as labelled and are substantially equivalent to predicate devices.