Predicate Devices

Reference Devices

K130318, K183541, K181279, K190373, K142698, K142049, K140551, K182517, K130883, K093066, K161730, K140825

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, deep learning, or any related terms. The device description focuses on standard radiographic components and image processing, which is common in digital X-ray systems and does not inherently imply AI/ML.

Therapeutic

No

This device is a diagnostic X-ray system used for generating images, not for treating diseases or conditions.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section states that the system is for "generating diagnostic images" and the "Device Description" section states it is a "diagnostic X-Ray system".

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including an X-Ray tube suspension, Bucky stand, patient table, X-Ray generator, X-Ray tube, beam limiting device, and a solid-state image receptor. It is a complete radiographic system, not just software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The DigiX FDX radiographic system is an X-ray imaging system. It works by generating X-rays that pass through the patient's body and are captured by a detector to create images. This is an in vivo process (occurring within the living body), not an in vitro process (occurring outside the living body).
Intended Use: The intended use clearly states it's for "radiographic exposure of the whole body" and generating "diagnostic images by converting X-Ray into electronics signals." This aligns with diagnostic imaging, not laboratory testing of specimens.

The description of the device, its components, and its function all point to it being a medical imaging device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatic patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications. Exposure may be taken with the Patient's sitting, standing, or in the prone/ supine position.

The DigiX FDX System is not meant for mammography.

The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.

Product codes (comma separated list FDA assigned to the subject device)

KPR

Device Description

The DigiX FDX system is a diagnostic X-Ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaqing.

The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted X-Ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, X-Ray generator, X-Ray tube, beam limiting device, and a solid-state image receptor.

The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray

Anatomical Site

whole body including: Skull, chest, abdomen, and extremities

Indicated Patient Age Range

pediatric, adult and bariatric patients

Intended User / Care Setting

hospitals, clinics and medical practices

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)

Non-clinical testing included verification and validation testing, image evaluation, testing, and safety testing. All devices subject to CDRH performance standards are certified to comply with the standard by their respective manufacturers. Risk Analysis was performed on the entire system.

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.

The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

EMC/electrical safety was evaluated according to the IEC Standards. Allengers certify conformance to Voluntary Standards covering Electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed.

Performance testing included functional testing of all motions of the system(s) with respect to the design specifications. Image performance testing was conducted and results included in the submission. All functions met the design requirements and the image performance criteria satisfactorily.

Clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K162529, K081722

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K130318, K183541, K181279, K190373, K142698, K142049, K140551, K182517, K130883, K093066, K161730, K140825

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

0

Image /page/0/Picture/10 description: The image contains 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 text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.

Allengers Medical Systems Limited % Mr. Sanjeev K. Marjara Director Technical Bhankharpur, Mubarakpur Road Derabassi, Distt Mohali, Punjab 140507 INDIA

Re: K192541

Trade/Device Name: DigiX FDX Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: September 10, 2019 Received: September 16, 2019

Dear Mr. Sanjeev Marjara:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

October 16, 2019

1

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

Sincerely.

For

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

Enclosure

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Indications for Use

510(k) Number (if known) K192541

Device Name

DigiX FDX

Indications for Use (Describe)

The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatic patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications. Exposure may be taken with the Patient's sitting, standing, or in the prone/ supine position.

The DigiX FDX System is not meant for mammography.

The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.

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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510(k) SUMMARY K192541

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR 807.92

1. Classification and Device Name

Device (trade) Name: DigiX FDX
----------------------------------	--

Common/usual Name: Digital X-Ray imaging system

Classification Name: Stationary X-Ray system, Class II

Classification: 21 CFR 892.1680

Classification Name: Stationary X-Ray System

Classification Panel: Radiology

Device Class: Class II

Device Code: KPR

510(K) Submission: Special

2. Contact Person and Address

Company Name:	Allengers Medical Systems Limited
Address:	Bhankharpur, Mubarakpur
Road, Derabassi, Distt Mohali-140507
India
Telephone No:	+91 1762-272600,
+91 9872980168
Contact Person:	Sanjeev K. Marjara
Date Prepared:	10 September 2019

3. Predicate Device:

Predicate Device: DigiX FDX
Classification: 21 CFR 892.1680
Classification Name: Stationary X-Ray system
Common/usual Name: Digital X-Ray imaging system
Device Class: Class II
510(K) Number: K162529
Product Code: KPR

4

1. Secondary Predicate Device:
  Secondary Device: Ysio

Classification:	21 CFR 892.1680
Classification Name:	Stationary X-Ray system
Common/usual Name:	Digital X-Ray imaging system
Device Class:	Class II
510(K) Number:	K081722
Product Code:	KPR

Allengers supplies digital detectors that have been previously cleared by the FDA or tested and evaluated per Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices. Table 1 provides the list of solid state X-Ray image detectors used in device

Solid State X-Ray Image Detectors	510(K) Numbers
Varex PaxScan 4343R – Fixed	K130318
Varex PaxScan 4343R v3- Fixed	K183541
Thales Pixium RAD 4343 C-E (Fixed)	K181279
Varex Paxscan 4343CB - Fixed	K190373
IRAY VENU 1717X – Fixed	--
Varex PaxScan 4336R - Portable	K130318
Varex (Perkin Elmer ) XRPAD 4343F	K142698
Varex PaxScan 4336W - Wireless	K142049
Varex (Perkin Elmer) XRPAD 4336 – Wireless	K140551
Varex PaxScan 4336W v4 - Wireless	K183541
Varex PaxScan 4336W v4 + - Wireless	--
Thales Pixium 3543 DR-CS (Wireless)	K182517
IRAY VENU 1417V (Wireless)	--

*Table 1 List of Solid State X-Rav Image Detectors

All the above mentioned Solid State X-Ray Image Detectors (Digital detectors) can be used with Dual Energy Subtraction feature.

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5. Device Description:

The DigiX FDX system is a diagnostic X-Ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaqing.

The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted X-Ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, X-Ray generator, X-Ray tube, beam limiting device, and a solid-state image receptor.

The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections.

The following in Table 2 are the specific components for various configurations of the system. A complete system will consist of a selection of one of the devices in each category.

Component	Manufacture	Model
Ceiling Mounted X-Ray Tube Suspension	Allengers	CSA FDX
Vertical Bucky Stand	Allengers	VBS ADV
Vertical Bucky Stand	Allengers	VBS M XL
Patient Table - Fixed	Allengers	Floatex ADV
Patient Table - Fixed	Allengers	Floatex
Patient Table - Fixed	Allengers	Floatex XL
Patient Table - Mobile	Allengers	MobiT 6C
Patient Table - Mobile	Allengers	MobiT 4C
Patient Table - Mobile	Allengers	MobiT C
X-Ray Generator	Allengers	XGEN-80R
X-Ray Generator	Allengers	XGEN-65R
X-Ray Tube	Varex	A192
X-Ray Tube	Varex	A292
X-Ray Tube	Varex	G292
X-Ray Tube	Varex	G1092
X-Ray Tube	Varex	RAD14
Beam Limiting Device	Ralco	R225 ACS
Solid State X-Ray Image Detector - Fixed	Varex	PaxScan 4343R
Solid State X-Ray Image Detector - Fixed	Varex	PaxScan 4343R v3
Solid State X-Ray Image Detector -
Portable Wired	Varex	PaxScan 4336R
Solid State X-Ray Image Detector -
Portable Wired	Varex (Perkin
Elmer)	XRPAD 4343F
Solid State X-Ray Image Detector - Fixed	Varex	PaxScan 4343CB
Solid State X-Ray Image Detector - Fixed	Thales	Pixium Rad 4343 CE

Table 2 Combination Detail

6

Solid State X-Ray Image Detector - Fixed	IRAY	VENU 1717X
Solid State X-Ray Image Detector – WiFi	Varex	PaxScan 4336W
Solid State X-Ray Image Detector – WiFi	Varex	PaxScan 4336W V4
Solid State X-Ray Image Detector – WiFi	Varex	PaxScan 4336W V4 +
Solid State X-Ray Image Detector – WiFi	Varex (Perkin
Elmer)	XRPAD 4336
Solid State X-Ray Image Detector - WiFi	Thales	Pixium 3543DR-CS
Solid State X-Ray Image Detector - WiFi	IRAY	MARS 1417V

6. Technological Characteristics Comparison to Predicate Device:

The Subject device DigiX FDX design is based on the Allenger's DigiX FDX (K162529) including the system control, Indication for use and mechanical design.

The modifications do not affect the intended use of the device the subject device and predicate device are based on the following same fundamental scientific technologies elements:

Energy emission to the patient X-Ray ●
Power requirement, Environmental requirement ●
. Mechanism to generate X-Rav
. Mechanism to acquire, process and store image data
Use of the hardware components ●
Use of software processing

This 510(k) submission describes some modifications to the previously cleared predicate devices the DigiX FDX (K162529). The changes to the predicate DigiX FDX (K162529) include:

System Software Synergy DR FDX

Synergy DR FDX comparable to ECOM DROC (K130883) added with same functionality along with below said additional features.

. Operating System: Updated operating system from Windows 7 to Windows 10
Automatic Stitching: Image stitching is the process of overlapping two or more images taken at different viewpoints and different times to generate a wider viewing panoramic image.
. **Dual Energy Subtraction: Dual energy subtraction (DES) radiography, a new added feature for software Synergy DR FDX, is a technique which aims to improve the diagnostic value of an X-Ray by separating soft tissue from bones, producing two different images.

** Dual Energy Subtraction feature can be used with all the Solid State X-Ray Image detectors (Digital detectors) listed in table 1 of this 510(k) summary.

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Component Change

X-Ray Tube : RAD-14 (Make : Varex Imaging) is added ●
. 43x36cm Wireless Detectors are added (Listed below),
- Paxscan 4336W v4 manufactured by Varex Imaging ●
  - . Pixium 3543 DR-CS manufactured by Thales.
  - . MARS 1417V manufactured by IRAY technology.
. 43x43cm Fixed Detectors are added (Listed below),
- Paxscan 4343R v3 manufactured by Varex imaging ●
- Pixium Rad 4343 C-E manufactured by Thales ●
- VENU 17171X manufactured by IRAY technology. ●
- Paxscan 4343CB manufactured by Varex Imaging. ●
. Wireless IR Remote (Optional) added.
Monitor with 19" or more in size (touch and Non touch) added.
Patient Table: Minor changes in mechanical dimensions and increase the ● load carrying capacity of patient tables.

Others Change

EMC (Electromagnetic Compatibility) was tested according to IEC ed. 4.0. ●
Combination Name change (Refer Table 4 for more detail) ●
Brand Name M/s Varian to M/s Varex imaging (FPD & X-Ray Tube ● Manufacturer)

7. Indications for Use:

The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications.

Exposure may be taken with the Patient's sitting, standing, or in the prone/supine position.

The DigiX FDX System is not meant for mammography.

The DigiX FDX uses an integrated or portable or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.

8

8. Substantial Equivalence:

The DigiX FDX radiographic X-Ray system is substantially equivalent to the commercially available primary predicate Allenger's DigiX FDX Cleared March 3, 2017 with K162529

Mechanical dimensions was slightly change, however the changes doesn't impact the intended use of device. Table 3 provides primary and secondary predicate comparable information

| Predicate Device(s) Name
and Manufacture | 510(K)
Number | Clearance Date | Comparable
Properties |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------------|----------------------------------------------------------------|
| Primary Predicate Device
DigiX FDX
Product Code: KPR
Address: Allengers
Medical Systems Ltd.
Bhankharpur, Mubarakpur
Road, Derabassi, Distt
Mohali-140507 India | K162529 | 3/3/2017 | • Technical Design
• Mechanical Design
• System Software |
| Secondary Predicate
Device: Ysio
Product Code: KPR
Address: Siemens Medical
Solutions USA, Inc,
51 valley stream, Parkway
E-50, Malvern PA, 19335-
1406 | K081722 | 8/25/2008 | • Technical Design
• Mechanical Design
• System Software |

Table 3 Predicate Device Comparable Properties

9

		Table 4: Functional and Specification Differences
--	--	----------------------------------------------------	--

| Feature | Subject Device
DigiX FDX | Predicate 1
DigiX FDX | Predicate 2
Siemens Ysio | Comparison
Results |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| 1. 510(K) | K192541 | K162529 | K081722 | Same |
| 2. Classification | | | | |
| Classification | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 | Same |
| Clinical Characteristics | | | | |
| 3. Indication for Use | | | | |
| Indications for
Use | The DigiX FDX
radiographic systems
are used in hospitals,
clinics and medical
practices. DigiX FDX
enables radiographic
exposure of the whole
body including: Skull,
chest, abdomen, and
extremities and may be
used on pediatric, adult
and bariatric patients. It
can also be used for
intravenous, small
interventions (like
biopsy, punctures, etc.)
and emergency
(trauma critical ill)
applications.
Exposure may be taken
with the Patient's
sitting, standing, or in
the prone/supine
position.
The DigiX FDX System
is not meant for
mammography.
The DigiX FDX uses an
integrated or portable
or fixed or Wi-Fi digital
detector for generating
diagnostic images by
converting X-Ray into
electronics signals. | The DigiX FDX
radiographic
systems are used
in hospitals, clinics
and medical
practices. DigiX
FDX enables
radiographic
exposure of the
whole body
including: Skull,
chest, abdomen,
and extremities
and may be used
on pediatric, adult
and bariatric
patients. It can
also be used for
intravenous, small
interventions (like
biopsy, punctures,
etc.) and
emergency
(trauma critical ill)
applications.
Exposure may be
taken with the
Patient's sitting,
standing, or in the
prone/supine
position.
The DigiX FDX
System is not
meant for
mammography. | The Ysio (New RAD
Family) systems are
the radiographic
systems used in
hospitals, clinics, and
medical practices. Ysio
enables radiographic
and tomographic
exposures of the whole
body including: skull,
chest, abdomen, and
extremities and may be
used on pediatric, adult
and bariatric patients.
It can also be used for
intravenous, small
interventions (like
biopsy, punctures, etc.)
and emergency
(trauma, critical ill)
applications.
Exposures may be
taken with the patient
sitting, standing, or in
the prone position. The
Ysio system is not
meant for
mammography. The
Ysio uses an
integrated or portable
digital detector for
generating diagnostic
images by converting
X-Rays into electronic
signals. Ysio is also
designed to be used | Same as
predicate 1 |
| | DigiX FDX is also
designed to be used
with conventional
film/screen or
Computed
Radiography (CR)
Cassettes. | The DigiX FDX
uses an integrated
or portable or fixed
or Wi-Fi digital
detector for
generating
diagnostic images
by converting X-
Ray into
electronics
signals. DigiX FDX
is also designed to
be used with
conventional
film/screen or
Computed
Radiography (CR)
Cassettes. | with conventional
film/screen or
Computed
Radiography (CR)
Cassettes | |
| Technical Characteristics | | | | |
| 4. | Ceiling Mounted X-Ray Tube Suspension | | | |
| Model | CSA FDX | CSAAdv & CSAFDX | Ysio | |
| Longitudinal
travel | 300 cm | 300 cm | 346 cm | Same as
predicate 1 |
| Transverse
travel | 200 cm | 200 cm | 220 cm | Same as
predicate 1 |
| Vertical travel | 150 cm | 150 cm | 190 cm | Same as
predicate 1 |
| Tube rotation
(horiz.) | $ \pm 180^\circ $ | $ \pm 180^\circ $ | $ \pm 180^\circ $ | Same |
| Tube rotation
(vert.) | $ \pm 180^\circ $ | $ \pm 180^\circ $ | $ \pm 180^\circ $ | Same |
| Fully
automated | Yes | Yes | Yes | Same |
| Digital
Readout | Yes | Yes | Yes | Same |
| 5. Vertical Bucky Stand | | | | |
| Model | VBS ADV | VBSAdv | BWS with Max static | Same as |
| Vertical travel | 125 cm | 125 cm | 145 cm | predicate 1 |
| Model | VBS M XL | VBS MXL | BWS wi-D | Same as |
| Vertical travel | 162 cm | 162 cm | 141 cm | predicate 1 |
| 6. Patient Table | | | | |
| Model | FloatexXL | FloatexXL | Bucky Table | |
| Type | 4-way floating top | 4-way floating
Top | 4-way floating top | Same |
| Longitudinal
travel | 95 cm | 95 cm, | NA | Same |
| Transverse
travel | 25 cm | 25 cm, | NA | Same |
| Table top
locking | Electromagnetic | Electromagnetic | Electromagnetic | Same |
| Maximum
patient
capacity | 250 kg (551 lbs) | 200 kg (440 lbs) | 300 kg (660 lbs) | Similar
Functionality
(Note 1) |
| | | | | |
| Model | Floatex ADV | Floatex+ | Bucky Table | |
| Type | 6-way floating top | 6-way floating top | 6-way floating top | Same |
| Longitudinal
travel | 95 cm | 53.5 cm | NA | Similar
Functionality
(Note 2) |
| Transverse
travel | 25 cm | 18 cm | NA | Similar
Functionality
(Note 2) |
| Vertical travel | 26.5 cm | 26.5 cm | 29 cm | Same as
predicate 1 |
| Table top
locking | Electromagnetic | Electromagnetic | Electromagnetic | Same |
| Maximum
patient
capacity | 250 kg (551 lbs) | 200 kg (440 lbs) | 300 kg (660 lbs) | Similar
Functionality
(Note 1) |
| | | | | |
| Optional
Model | Floatex | Floatex | NA | |
| Type | 4-way floating top | 4-way floating top | NA | Same |
| Longitudinal
travel | 53.5 cm | 53.5 cm | NA | Same |
| Transverse
travel | 20 cm | 20 cm | NA | Same |
| Table top
locking | Electromagnetic | Electromagnetic | NA | Same |
| Maximum
patient
capacity | 250 kg (551 lbs) | 200 kg (440 lbs) | NA | Similar
Functionality
(Note 1) |
| | | | | |
| Optional
Model | MobiT 6C | MobiT 6C | NA | |
| Type | Mobile with floating
top | Mobile with
floating top | NA | Same |
| Longitudinal
travel | 60 cm | 60 cm | NA | Same |
| Transverse
ravel | 20 cm | 20 cm | NA | Same |
| Vertical travel | 40 cm | 40 cm | NA | Same |
| Table top
locking | Electromagnetic | Electromagnetic | NA | Same |
| Maximum
patient
capacity | 250 kg (551 lbs) | 200 kg (440 lbs) | NA | Similar
Functionality
(Note 1) |
| | | | | |
| Optional | MobiT 4C | MobiT 4C | NA | |
| Model | | | | |
| Type | Mobile with floating
top | Mobile with
floating top | NA | Same |
| Longitudinal
travel | 60 cm | 60 cm | NA | Same |
| Transverse
travel | 20 cm | 20 cm | NA | Same |
| Table top
locking | Electromagnetic | Electromagnetic | NA | Same |
| Maximum
patient
capacity | 250 kg (551 lbs) | 200 kg (440 lbs) | NA | Similar
Functionality
(Note 1) |
| | | | | |
| Optional
Model | Mobit C | Mobit C | NA | |
| Type | Mobile | Mobile | NA | Same |
| Table top | Fixed | Fixed | NA | Same |
| Maximum
patient
capacity | 200 kg (440 lbs) | 200 kg (440 lbs) | NA | Same |
| 7. X-Ray Generator | | | | |
| Kilowatt
rating | 65 kW
80 kW | 65 kW standard
80 kW optional | 65 kW standard
80 kW optional | Same |
| kV minimum
(65/80) | 40/40 kV | 40/40 kV | 40/40 kV | Same |
| kV maximum
(65/80) | 150/150 kV | 150/150 kV | 150/150 kV | Same |
| mA
maximum @
100kV
(65/80) | 650/800 mA | 650/800 mA | 650/800 mA | Same |
| mAs Range
(65/80) | 800/10000mAs | 800/1000mAs | NS | Same as
predicate 1 |
| APR
programming | Yes | Yes | Yes | Same |
| IR Remote | Yes | No | NA | New Feature
(Note 3) |
| 8. X-Ray Tube | | | | |
| Tube Type | Varex Imaging G1092 | Varex Imaging
G1092 | Siemens OPTITOP | Same as
predicate 1 |
| Focal Spot
sizes | 0.6mm / 1.2mm | 0.6mm / 1.2mm | 0.6mm / 1.0mm | Same as
predicate 1 |
| Heat Units | 1 MHU | 1 MHU | 783 KHU | Same as
predicate 1 |
| Target Angle | 12° | 12° | 12° | Same |
| Target
Diameter | 108 mm | 108 mm | 100 mm | Same as
predicate 1 |
| Target
Material | RTM | RTM | RTM | Same |
| | | | | |
| Optional
Tube | Varex Imaging G292 | Varex Imaging
G292 | Siemens OPTILIX | |
| Focal Spot
sizes | 0.6mm / 1.2mm | 0.6mm / 1.2mm | 0.6mm / 1.0mm | Same as
predicate 1 |
| Heat Units | 600 kHU | 600 KHU | 600 kHU | Same |
| Target Angle | 12° | 12° | 16° | Same as
predicate 1 |
| Target
Diameter | 102 mm | 102 mm | 100 mm | Same as
predicate 1 |
| Target
Material | RTM | RTM | RTM | Same |
| Optional
Tube | Varex Imaging A292 | Varex Imaging
A292 | NA | |
| Focal Spot
sizes | 0.6mm / 1.2mm | 0.6mm / 1.2mm | NA | Same |
| Heat Units | 400 kHU | 400 kHU | NA | Same |
| Target Angle | 12° | 12° | NA | Same |
| Target
Diameter | 102 mm | 102 mm | NA | Same |
| Target
Material | RTM | RTM | NA | Same |
| Optional
Tube | Varex Imaging A192 | Varex Imaging
A192 | NA | |
| Focal Spot
sizes | 0.6mm / 1.2mm | 0.6mm / 1.2mm | NA | Same |
| Heat Units | 300 KHU | 300 KHU | NA | Same |
| Target Angle | 12° | 12° | NA | Same |
| Target
Diameter | 102 mm | 102 mm | NA | Same |
| Target
Material | RTM | RTM | NA | Same |
| Optional
Tube | Varex Imaging RAD
14 | Varex Imaging
A192 | NA | |
| Focal Spot
sizes | 0.6mm / 1.2 mm | 0.6mm / 1.2mm | NA | Same |
| Heat Units | 300 kHU | 300 kHU | NA | Same |
| Target Angle | 12° | 12° | NA | Same |
| Target
Diameter | 80 mm | 102 mm | NA | Similar
Functionality
(Note 4) |
| Target
Material | RTM | RTM | NA | Same |
| Beam Limiting Device | | | | |
| Construction | Multi-leaf | Multi-leaf | Multi-leaf | Same |
| CFR
211020.31 | Compliant | Compliant | Compliant | Same |
| Automatic | Yes | Yes | Yes | Same |

10

11

12

13

14

Model	XRPAD 4343 F	XRPAD 4343F	Trixell Pixium 4600
FDA Cleared	Yes, K142698	Yes, K142698	Yes, K093066
Panel Type	Single substrate
amorphous silicon
active TFT/diode array	Single substrate
amorphous
silicon active
TFT/diode array	Amorphous Silicon	Same as
predicate 1
Active area	432 mm X 432 mm	432 mm X 432
mm	429 mm X 429 mm	Same as
predicate 1
Pixel pitch	100 μm	100 μm	143 μm	Same as
predicate 1
Pixel matrix	4318 X 4320	4318 X 4320	3001 x 3001	Same as
predicate 1
Scintillator	Direct deposition
Csl:TI	Direct deposition
Csl:TI	Cesium lodide	Same or
similar with
same imaging
results
Limiting
resolution	5 lp/mm	5 lp/mm	3.6 lp/mm	Same as
predicate 1

Optional
Model	Varex's PaxScan
4336R	Varex's PaxScan
4336R	Thales Pixium 3543
FDA Cleared	Yes, K130318	Yes, K130318	Yes, K093066
Panel Type	Amorphous Silicon
with Charge Well
Pixel™ Technology	Amorphous
Silicon with
Charge Well
Pixel™
Technology	Pixium© Csl coupled to
TFT matrix aSi
technology	Same as
predicate 1
Pixel
Area(Active)	353 mm X 424mm	353mm X 424
mm	342 mm X 432 mm	Same as
predicate 1
Pixel pitch	139 μm	139 μm	144 μm	Same as
predicate 1
Pixel matrix	2560 X 3072	2560 X 3072	2372 X 3000	Same as
predicate 1
Scintillator	Direct Deposit Csl,
Detached Csl, DRZ
Plus	Direct Deposit
Csl, Detached
Csl, DRZ Plus	Cesium lodide	Same as
predicate 1
Limiting
resolution	3.6 lp/mm	3.6 lp/mm	3.6 lp/mm	Same

Model	XRPAD 4336	XRPAD 4336	Thales Pixium 3543
FDA Cleared	Yes, K140551	Yes, K140551	Yes, K093066
Panel Type	Single substrate
amorphous silicon
active TFT/diode array	Single substrate
amorphous
silicon active
TFT/diode array	Pixium© Csl coupled to
TFT matrix aSi
technology	Same as
predicate 1
Active Area	355 mm X 432 mm	355 mm X 432
mm	342 mm X 432 mm	Same as
predicate 1
Pixel pitch	100 μm	100 μm	144 μm	Same as
predicate 1
Pixel matrix	3556 X 4320	3556 X 4320	2372 X 3000	Same as
				predicate 1
Scintillator	Direct deposition
CsI:TI	Direct deposition
CsI:TI	Cesium Iodide	Same as
predicate 1
Limiting resolution	5 lp/mm	5 lp/mm	3.6 lp/mm	Same as
predicate 1
Optional Model	Varex's PaxScan
4336W	Varex's PaxScan
4336W	Thales Pixium 3543
FDA Cleared	Yes, K142049	Yes, K142049	Yes, K093066
Panel Type	Amorphous Silicon	Amorphous Silicon	Pixium© Csl coupled to
TFT matrix aSi
technology	Same as
predicate 1
Active Area	353 mm X 424 mm	353 mm X 424 mm	342 mm X 432 mm	Same as
predicate 1
Pixel pitch	139 μm	139 μm	144 μm	Same as
predicate 1
Pixel matrix	2560 X 3072	2560 X 3072	2372 X 3000	Same as
predicate 1
Scintillator	Direct Deposit Csl,
DRZ +	Direct Deposit
Csl, DRZ +	Cesium Iodide	Same as
predicate 1
Limiting resolution	3.6 lp/mm	3.6 lp/mm	3.6 lp/mm	Same
Optional Model	Varex's PaxScan
4336W v4	Varex's PaxScan
4336W	Thales Pixium 3543
FDA Cleared	Yes, K183541	Yes, K142049	Yes, K093066
Panel Type	Amorphous Silicon
with TFT/PIN diode
Technology	Amorphous Silicon	Pixium© Csl coupled to
TFT matrix aSi
technology )	Similar with
same imaging
results
Active Area	339 mm X 424 mm	353 mm X 424 mm	342 mm X 432 mm	Similar
Functionality
(Note 5)
Pixel pitch	139 μm	139 μm	144 μm	Same as
predicate 1
Pixel matrix	2476 X 3072	2560 X 3072	2372 X 3000	Similar
Functionality
(Note 5)
Scintillator	Csl, DRZ +	Csl, DRZ +	Cesium lodide(CSI:Ti)	Same as
predicate 1
Limiting resolution	3.6 lp/mm	3.6 lp/mm	3.6 lp/mm	Same
Optional Model	Thales Pixium 3543
DR-CS	Varex's PaxScan
4336W	Thales Pixium 3543
FDA Cleared	Yes, K182517	Yes, K142049	Yes, K093066
Panel Type	Pixium® Csl coupled
to TFT matrix a-Si
technology	Amorphous Silicon	Pixium© Csl coupled to
TFT matrix aSi
technology	Same as
predicate 2
Active Area	350mm x430 mm	353 mm X 424 mm	342 mm X 432 mm	Similar
Functionality
(Note 5)
Pixel pitch	160 µm	139 µm	144 µm	Similar
Functionality
(Note 5)
Scintillator	Cesium Iodide(CSI:Ti)	CsI, DRZ +	Cesium Iodide	Same
Optional
Model	Varex's PaxScan
4343R	Varex's PaxScan
4343R	Trixell Pixium 4600
FDA Cleared	Yes, K130318	Yes, K130318	Yes, K093066
Panel Type	Amorphous Silicon
with Charge Well
Pixel™Technology	Amorphous
Silicon with
Charge Well
Pixel™Technology	Amorphous Silicon	Same as
predicate 1
Active Area	424 mm × 424 mm	424 mm × 424 mm	429 mm × 429 mm	Same as
predicate 1
Pixel pitch	139 µm	139 µm	143 µm	Same as
predicate 1
Pixel matrix	3072 × 3072	3072 × 3072	3001 × 3001	Same as
predicate 1
Scintillator	Direct Deposit CsI,
Detached CsI, DRZ
Plus	Direct Deposit
CsI, Detached
CsI, DRZ Plus	Cesium Iodide	Same as
predicate 1
Limiting
resolution	3.6 lp/mm	3.6 lp/mm	3.6 lp/mm	Same
Optional
Model	VENU 1717X	Varex Paxscan
4343R	Trixell Pixium 4600
Panel Type	Amorphous Silicon	Amorphous
Silicon with
Charge Well
Pixel™Technology	Amorphous Silicon	Same as
predicate 2
Active Area	427 × 427 mm	424 mm × 424 mm	429 mm × 429 mm	Essentially the
Same imaging
Area doesn't
affect the
patient safety
or
effectiveness.
Pixel pitch	139 µm	139 µm	143 µm	Same as
predicate 1
Pixel matrix	3072 × 3072	3072 × 3072	3001 × 3001	Same as
predicate 1
Scintillator	CsI	Direct Deposit
CsI, Detached
CsI, DRZ Plus	CsI	Same as
predicate 2
Limiting
resolution	3.6 lp/mm	3.6 lp/mm	3.6 lp/mm	Same
Optional
Model	Varex's PaxScan
4343R v3	Varex's PaxScan
4343R	Trixell Pixium 4600
FDA Cleared	Yes, K183541	Yes, K130318	Yes, K093066
Panel Type	Amorphous Silicon
with PIN Technology	Amorphous Silicon with
Charge Well Pixel™Technology	Amorphous Silicon	Same or
similar with
same imaging
results
Active Area	424 mm X 424 mm	424 mm X 424 mm	429 mm X 429 mm	Same as
predicate 1
Pixel pitch	139 µm	139 µm	143 µm	Same as
predicate 1
Pixel matrix	3072 X 3072	3072 X 3072	3001 x 3001	Same as
predicate 1
Scintillator	CsI, DRZ+	Direct Deposit
CsI, Detached
CsI, DRZ Plus	Cesium lodide	Same or
Similar with
same imaging
results
Limiting resolution	3.6 lp/mm	3.6 lp/mm	3.6 lp/mm	Same

Optional Model	Pixium RAD 4343 C-E	Varex's PaxScan 4343R	Trixell Pixium 4600
FDA Cleared	Yes, K181279	Yes, K130318	Yes, K093066
Panel Type	Amorphous Silicon	Amorphous Silicon with
Charge Well Pixel™Technology	Amorphous Silicon	Same as
predicate 2
Active Area	423.3 x 425.4	424 mm X 424 mm	429 mm X 429 mm	Similar
Functionality
(Note 5)
Pixel pitch	148 µm	139 µm	143 µm	Similar
Functionality
(Note 5)
Pixel matrix	2860 X 2874	3072 X 3072	3001 x 3001	Similar
Functionality
(Note 5)
Scintillator	Cesium lodide(CSI)	Direct Deposit
CsI, Detached
CsI, DRZ	Cesium lodide	Same as
predicate 2

Optional Model	Paxscan 4343CB	Varex's PaxScan 4343R	Trixell Pixium 4600
FDA Cleared	Yes, K190373	Yes, K130318	Yes, K093066
Panel Type	Amorphous Silicon	Amorphous Silicon with
Charge Well Pixel™Technology	Amorphous Silicon	Similar with
Same imaging
result
Active Area	427mm x 427 mm	427mm x 427 mm	429 mm X 429 mm	Same as
predicate 1
Pixel pitch	139 µm	139 µm	143 µm	Same as
				predicate 1
Pixel matrix	3072 X 3072	3072 X 3072	3001 x 3001	Same as
predicate 1
Scintillator	Integral columnar
Csl:TI	Direct Deposit
Csl, Detached
Csl, DRZ	Cesium lodide	Similar
Functionality
(Note 5)
Optional
Model	Varex's PaxScan
4336W v4 +	Varex's PaxScan
4336W	Thales Pixium 3543
Panel Type	Amorphous Silicon
with TFT/PIN diode
Technology	Amorphous
Silicon with
TFT/PIN diode
Technology	Pixium© Csl coupled to
TFT matrix aSi
technology	Same as
predicate 1
Active Area	339 mm X 424 mm	353 mm X 424
mm	342 mm X 432 mm	Similar
Functionality
(Note 6)
Pixel pitch	139 µm	139 µm	144 µm	Same as
predicate 1
Pixel matrix	2476 X 3072	2560 X 3072	2372 X 3000	Similar
Functionality
(Note 6)
Scintillator	Csl, DRZ +	Csl, DRZ +	Cesium lodide	Same as
predicate 1
Limiting
resolution	3.6 lp/mm	3.6 lp/mm	3.6 lp/mm	Same
Optional
Model	MARS 1417V	Varex's PaxScan
4336W	Thales Pixium 3543
Panel Type	a-Si (Amorphous
Silicon) TFT	Amorphous
Silicon	Pixium© Csl coupled to
TFT matrix aSi
technology	Same or
Similar
Functionality
(Note 7)
Active Area	346 X 420	353 mm X 424
mm	342 mm X 432 mm	Same or
Similar
Functionality
(Note 7)
Pixel pitch	150 µm	139 µm	144 µm	Same or
Similar
Functionality
(Note 7)
Pixel matrix	2304 x 2800	2560 X 3072	2372 X 3000	Same or
Similar
Functionality
(Note 7)
Scintillator	Csl	Csl, DRZ +	Cesium lodide	Same as
predicate 2
Limiting
Resolution	3.4 lp/mm	3.6 lp/mm	3.6 lp/mm	Same or
Similar
Functionality
(Note 7)

Allengers Medical Systems Limited DigiX FDX 510(k)

Section 5-0

15

16

17

18

19

| 11. Viewing Monitors | 19 inch or more
(Touch and Non
Touch) | 19 inch Monitor | 19 inch Monitor | Similar
Functionality
( Note 8 ) | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------|
| 12. Software Feature | | | | | |
| Model | Synergy
DR FDX | DROC | DROC | DelWorks DR System | |
| FDA Cleared | | K130883 | Yes, K130883 | Yes, K140825 | |
| Operating
System | Microsoft
Windows
7/
Microsoft
Window
10 | Microsoft
Windows7
/ Microsoft
Window
10 | Microsoft
Windows7 | Microsoft Windows7 | Similar
Functionality
(Note 9) |
| Network | Ethernet/
Wifi | Ethernet/
Wifi | Ethernet/ Wifi | Ethernet/ Wifi | Same |
| User | Mouse,
Keyboard | Mouse,
Keyboard, | Mouse,
Keyboard, | Mouse, Keyboard, | Same |
| Interaction/in
put | Touch
Monitor, | Touch
Monitor, | Touch Monitor, | Touch Monitor, | Same |
| Multi-user | Available | Available | Available | Available | Same |
| Import/Export
images | Yes | Yes | Yes | Yes | Same |
| Acquisition
device | Computed
Radiogra
phy
Digital X-
Ray
Detector | Computed
Radiograp
hy Digital
X-Ray
Detector | Computed
Radiography
Digital X-Ray
Detector | Computed
Radiography Digital X-
Ray Detector | Same |
| Image
Interferences | Detector
depende
nt | Detector
dependent | Detector
dependent | Detector dependent | Same |
| Image
Organization | Yes
Patient
ID/Name/
Study
instance
UID
Patient
ID/Name/
Study
instance
UID | Yes
Patient
ID/Name/
Study
instance
UID
Patient
ID/Name/
Study
instance
UID | Yes
Patient
ID/Name/Study
instance UID
Patient
ID/Name/Study
instance UID | Yes
Patient
ID/Name/Study
instance UID
Patient
ID/Name/Study
instance UID | Same |
| Image
Search
available | Yes | Yes | Yes | Yes | Same |
| Image
Storage | Yes | Yes | Yes | Yes | Same |
| Database | Yes | Yes | Yes | Yes | Same |
| storage | | | | | |
| Database Software | MS-Access | MS-Access | MS-Access | MS-Access | Same |
| Image Viewing | Yes | Yes | Yes | Yes | Same |
| Image measurement | Yes | Yes | Yes | Yes | Same |
| Image Annotation | Yes | Yes | Yes | Yes | Same |
| Image Operation | Yes | Yes | Yes | Yes | Same |
| Image Stitching | Automatic | Manual | Manual | Manual | Similar Functionality (Note 9) |
| Same Security | Yes(Priority by User) | Yes(Priority by User) | Yes(Priority by User) | Yes(Priority by User) | Same |
| DICOM 3.0 Compatibility | Yes | Yes | Yes | Yes | Same |
| Generator Control | Yes | Yes | Yes | Yes | Same |
| Generator Control Protocols | Generator dependent | Generator dependent | Generator dependent | Generator dependent | Same |
| Raw image Data Processing | Yes | Yes | Yes | Yes | Same |
| Post image data processing | Yes | Yes | Yes | Yes | Same |
| RIS code manager | Yes | Yes | Yes | Yes | Same |
| Dual Energy Subtraction | Yes | No | No | No | New Feature added (Note 10) |
| 13. Biological Characteristics | | | | | |
| Table Top Material | Carbon Composite Material | | Carbon Composite Material | Carbon Composite Material | Same |

20

Table 5 Justification for Differences

Note	Description
Note 1	Allengers DigiX FDX (Subject Device) is capable for carrying patient weight up to
250kg without raising any new risk related to patient safety or effectiveness.
Note 2	Patient table (Floatex ADV) modified with more travel which provide full patient
coverage which doesn't affect the safety or effectiveness of device.
Note 3	Optional Wireless IR Remote (make Tech switch) has same functionality as wired
hand switch for Exposure. Wireless version doesn't raise any new safety or
effectiveness issue. This feature is in EMC compliant and meet all necessary
requirements pertaining to hand switch design as stated in 21 CFR
Note 4	Varex Rad 14 X-Ray tube is new X-Ray tube for existing device. However, the X-
Ray tube used by subject device is already cleared by FDA under Stationary Digital
radiography X-Ray device under 510(K) number K183541. Having same focal spot
with different X-Ray tube loading and target diameter which provide essentially the
same imaging results, which doesn't affect the safety or effectiveness.
Note 5	The subject device utilizes different X-Ray flat panel detectors; however, the flat
panel detectors used by the subject device are already previously cleared by the
FDA and does not raise the level of safety concern and affect any effectiveness.
The relevant 510(k) approval number are K183541, K181279 & K182517
Note 6	New Detector Paxscan 4336W v4 + added in subject device. The flat panel
detector have all the technical specifications like Image area, Pixel Pitch, Active
area, resolution same to detector Paxscan 4336 W v4 (Previously cleared under
510 (K) No. K183541) with light weight facility. The new additional Flat panel
detector (Varex Paxscan 4336W v4+) doesn't affect the patient safety or
effectiveness.
Note 7	The Subject Device utilized different Flat panel X-Ray detector (i.e. MARS 1417V)
,However the flat panel detector used by subject device is updated version of
previously cleared FPD having 510(K) number K161730 with same imaging area,
pixel pitch and same spatial resolution. The new additional Flat panel detector
(MARS 1417V) doesn't affect the patient safety or effectiveness.
Note 8	Monitors with 19" or more in sizes (Touch and Non touch) are utilized in subject
device with same imaging results which doesn't affect the patient safety or
effectiveness.
Note 9	The subject device utilizes additional System software (SYNERGY DR FDX) with
same and updated functionalities like automatic Image stitching, Dual Energy
feature and update operating system. However Software Documentation for a
Moderate Level of Concern software per FDA's Guidance Document "guidance for
the Content of Premarket Submissions for Software Contained in Medical Devices"
issued on May 11, 2005 is also included as part of this submission. The new
software doesn't raise the level of safety concern and affect any effectiveness.
Note 10	Dual-energy subtraction chest radiography improves the radiologist's ability to
detect and accurately diagnose a wide variety of chest lesions. The major
advantage of this technique is that it makes calcification more conspicuous, an
essential aid in characterizing pulmonary nodules. Thus this new feature doesn't
affect the patient safety or effectiveness.

21

9. Reason for Submission

Modification of cleared device

22

10. Non-Clinical and Clinical Testing:

Non-clinical testing included verification and validation testing, image evaluation, testing, and safety testing. All devices subject to CDRH performance standards are certified to comply with the standard by their respective manufacturers. Risk Analysis was performed on the entire system.

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.

The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

EMC/electrical safety was evaluated according to the IEC Standards. Allengers certify conformance to Voluntary Standards covering Electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed.

Safety Information:

· The Allengers Medical Systems Limited systems comply with the applicable requirements of 21 CFR 1020.30, 21 CFR 1020.31.
· The Allengers Medical Systems Limited systems comply with the international safety standards:
- o IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012
- o IEC 60601-1-2:2014
- IEC 60601-1-3:2008+A1:2013 o
- IEC 60601-2-54:2009+A1:2015 o
- EN ISO 14971:2012 o
- IEC 62366-1:2015 o
- IEC 62304:2006+AMD1:2015 o

Performance Testing:

Performance testing included functional testing of all motions of the system(s) with respect to the design specifications. Image performance testing was conducted and results included in the submission. All functions met the design requirements and the image performance criteria satisfactorily.

Clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system.

11.Substantial Equivalence Conclusion:

The Allengers Medical Systems Limited systems do not introduce any new indications for use, nor does the use of the systems result in any new potential hazards. The operating environment and mechanical design is similar. Allengers Medical Systems Limited considers the DigiX FDX diagnostic X-Ray systems to be substantially equivalent with the predicate devices (K162529 & K081722) with respect to safety and effectiveness.