Predicate Devices

Reference Devices

K103591, K171270, K131106, K170332, K172951, K161459, K142698, K140551, K162555, K162552, K153312, K130883, K152172, K152767, K173823, K103050, K1881874

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard digital radiographic system that utilizes previously cleared image processing software. There is no mention of AI, ML, or any related concepts like training or test sets for algorithmic development.

Therapeutic

No.
The device is described as a "diagnostic x-ray system" intended for "taking diagnostic radiographic exposures," indicating its purpose is to create images for diagnosis rather than to treat conditions.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states that the system is "for taking diagnostic radiographic exposures" and the "Device Description" section states it is a "diagnostic x-ray system." Additionally, the "Summary of Performance Studies" indicates that clinical images allowed radiologists to make an "accurate diagnosis."

SaMD (Software as a Medical Device)

No

The device is described as a "Stationary Radiographic System" which includes physical components like an X-ray tube, generator, bucky, table, and collimator, in addition to software and a digital acquisition panel. It is a complete hardware and software system for generating and capturing X-ray images.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices 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 ProRad Series Stationary Radiographic System is an imaging device that uses X-rays to create images of the internal structures of the body. It does not analyze biological specimens.
Intended Use: The intended use clearly states it's for "taking diagnostic radiographic exposures" of various body parts. This is consistent with an imaging device, not an IVD.
Device Description: The description details the components of an X-ray system (X-ray tube, generator, bucky, table, collimator, digital panel, software) which are all related to generating and capturing radiographic images.
Input Modality: The input modality is X-ray, which is an imaging modality, not a method for analyzing biological samples.

Therefore, based on the provided information, the ProRad Series Stationary Radiographic System is a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ProRad Series Stationary Radiographic System is intended for use by a qualified, trained doctor or technician on both adult and paediatric 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.

Product codes

KPR, MQB

Device Description

The ProRad series Stationary Radiographic System is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. There are two types of configurations (2FC and 3NC) for ProRad; the difference is in the mounting of the X-ray tube. For X-ray tube mounting the configuration is either the floor mounted (2FC) or ceiling suspension (3NC) assembly.

The devices are a new combination of a previously cleared solid state digital x-ray acquisition panel and software with the diagnostic x-ray components (including Xray tube, high frequency X-ray generator, a tilting vertical bucky, X-ray table and collimator) required to make a complete system. The purchaser may select any of the digital panels and software based on the user's requirements. The other components are also available in different configurations to meet specific customer needs.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

skull, spinal column, chest, abdomen, extremities, and other body parts.

Indicated Patient Age Range

adult and paediatric subjects

Intended User / Care Setting

qualified, trained doctor or technician

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)

Summary of non-clinical testing:
The ProRad 2FC and ProRad 3NC Digital Stationary Radiographic Systems comply with the following standards:

. IEC 60601-1: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General ● requirements for basic safety Collateral standard: Electromagnetic compatibility requirements and tests
IEC 60601-1-3: General requirements for basic safety and essential ● performance - Collateral Standard: Radiation protection in diagnostic Xray equipment
IEC 60601-2-54: Particular requirements for the basic safety and essential ● performance of X-ray equipment for radiography and radioscopy
IEC 60601-1-6: Medical electrical equipment Part 1-6: General ● requirements for basic safety and essential performance - Collateral standard: Usability
ISO 14971: Medical devices. Application of risk management to medical ● devices

Furthermore, cybersecurity concerns were addressed based on the US FDA Guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 2014" in the device labeling of these products.

Summary of clinical testing:
Since the digital x-ray panels and software have previously received FDA clearance, a clinical study was not required as per the FDA guidance document. The following information was not necessary to demonstrate substantial equivalence but provides additional support that the device works as intended. Clinical images acquired by the device were reviewed by a radiologist. The images were found to be acceptable and allowed the radiologist to make an accurate diagnosis.

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

Not Found

Predicate Device(s)

K150816, K153119

Reference Device(s)

K103591, K171270, K131106, K170332, K172951, K161459, K142698, K140551, K162555, K162552, K153312, K130883, K152172, K152767, K173823, K103050, K1881874

Predetermined Change Control Plan (PCCP) - All Relevant Information

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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

Prognosys Medical Systems Private Limited % Dr. Shruti Sancheti Manager - Quality and Regulatory Affairs IZiel Healthcare 14. Hadapsar Industrial Estate Hadapsar, Pune, 411013 INDIA

January 24, 2019

Re: K183541

Trade/Device Name: ProRad 2FC and ProRad 3NC Digital Stationary Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: December 20, 2018 Received: December 21, 2018

Dear Dr.Sancheti:

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 mav, 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K183541

Device Name

ProRad 2FC and ProRad 3NC Digital Stationary Radiographic Systems

Indications for Use (Describe)

ProRad Series Stationary Radiographic System is intended for use by a qualified, trained doctor or technician on both adult and paediatric 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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(k) SUMMARY

510(k) summary of Safety and Effectiveness for ProRad 2FC and ProRad 3NC Stationary Radiographic Systems is provided in accordance with 21 CFR 807.92.

Date:	October 5, 2018
Submitter (Owner):	V. Krishna Prasad
President
Prognosys Medical Systems Pvt. Ltd.
No. 249, Ground Floor, Front Building, 4th Main
Road, Chamrajpet,
Bangalore - 560 018, Karnataka, India
Phone: +91-8026621544
E-mail Id: info@prognosysmedical.com
510(k) Contact Person:	Dr. Shruti Sancheti
Manager-Quality & Regulatory Affairs
IZiel Healthcare
14, Hadapsar Industrial Estate,
Hadapsar, Pune – 411013
India.
P: +91-72762 2555 M:+91-9518546814
Email: shruti.sancheti@izielhealthcare.com
Device Trade Name:	ProRad 2FC and ProRad 3NC Stationary
Radiographic Systems
Regulation Number:	21 CFR 892.1680
Regulation Description:	Stationary X-Ray System
Classification Panel:	Radiology
Device Class:	Class II
Product Code:	KPR, MQB
Predicate Device:	1. Jumong Series Stationary Radiographic System
(K150816)

Amrad Medical OTS Digital Radiography System,
Amrad Medical DFMTS Digital Radiography
System, Amrad Medical FRS Digital Radiography
System (K153119) |

Indications for Use:

The ProRad Series Stationary Radiographic System is intended for use by a qualified, trained doctor or technician on both adult and paediatric 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.

Description of the Device:

The ProRad series Stationary Radiographic System is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. There are two types of configurations (2FC and 3NC) for ProRad; the difference is in the

4

mounting of the X-ray tube. For X-ray tube mounting the configuration is either the floor mounted (2FC) or ceiling suspension (3NC) assembly.

The devices are a new combination of a previously cleared solid state digital x-ray acquisition panel and software with the diagnostic x-ray components (including Xray tube, high frequency X-ray generator, a tilting vertical bucky, X-ray table and collimator) required to make a complete system. The purchaser may select any of the digital panels and software based on the user's requirements. The other components are also available in different configurations to meet specific customer needs. The X-ray panel and imaging software have been previously cleared by the FDA, and most of the other components are used in previously cleared 510(k) devices (respective approval numbers are discussed in Section 11, Table 1). Details of the various configurations of all the components are given in Table 1 below:

| Component
Category | Component Description and
Model | Manufacturing
Location | ProRad
2FC | ProRad
3NC |
|------------------------------|-----------------------------------------------------------------------|---------------------------------|---------------|---------------|
| Digital
Imaging
System | CANON Flat Panel Detector CXDI-
401C Compact | Canon Inc., Japan | √ | √ |
| | CANON Flat Panel Detector CXDI-
410C Wireless | | √ | √ |
| | CANON Portable Detector CXDI-
701C Wireless | | √ | √ |
| | CANON Portable Detector CXDI-
710C Wireless | | √ | √ |
| | VAREX PAXSCAN 4343R v3 | Varian Medical
Systems, Inc. | √ | √ |
| | VAREX PAXSCAN 4336W v4
Wireless | | √ | √ |
| | VAREX (PerkinElmer) Flat Panel
Detector XRpad 4343F MED | Perkin-Elmer, Inc | √ | √ |
| | VAREX (PerkinElmer) Flat Panel
Detector XRpad 4336 MED
Wireless | | √ | √ |
| | DRTECH Digital Flat Panel X-ray
Detector EVS 4343, EVS 4343G | DRTECH
Corporation | √ | √ |
| | DRTECH Digital X-ray Detector
EVS 3643, EVS 3643G Wireless | | √ | √ |
| Image
Acquisition | Canon CXDI NE | Canon Inc., Japan | √ | √ |
| Software | DROC (Digital Radiography
Operator Console) | E-COM Technology
Ltd. | √ | √ |
| | Econsole1 | DRTECH Corp. | √ | √ |

Table 1: Available system configurations

5

| Component
Category | Component Description and
Model | Manufacturing
Location | ProRad
2FC | ProRad
3NC |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|---------------|---------------|
| X-ray
Generator | CPI CMP 200DR (32 kW, 40 kW, 50 kW, 65 kW, 80 kW) | Communications &
Power Industries,
Canada | √ | √ |
| X-ray Tube | TOSHIBA (E7239FX, E7242FX, E7252X, E7254X, E7869X, E7884X, E7843X) | TOSHIBA
ELECTRON
TUBES &
DEVICES CO.,
LTD. | √ | √ |
| | VAREX (RAD14, RAD60, RAD92) | Varian Medical
Systems, Inc. | √ | √ |
| Collimator | Ralco (R221, R225ACS) | Ralco Italy | √ | √ |
| | Daesung (M38) | Daesung
Corporation, Korea | √ | √ |
| Mechanical
Tube Stand | Ceiling Mounted Tube Stand

Full Auto- Single (SCS-FA)
Auto Tracking- Single (SCS-AT)
Manual- Single (SCS-MA)
Full Auto- Dual (DCS-FA)
Auto Tracking- Dual (DCS-AT)
Manual- Dual (DCS-MA)

Floor Mounted Tube Stand | | -- | √ |
| | - Full Auto- Single (SFT-FA)

Auto Tracking- Single (SFT-AT)
Manual- Single (SFT-MA)
Auto Tracking (FTC-AT)
Manual (FTC-MA)
Full Auto- Dual (DFT-FA)
Auto Tracking- Dual (DFT-AT)
Manual- Dual (DFT-MA) | | √ | -- |
| Mechanical
Bucky
Stand | Floor Mounted Vertical Bucky Stand
VB-MO
VB-MA
VBNTL-MO
VBNTL-MA | | √ | √ |
| Patient
Table | Mobile Patient Table PRO-MT
Mobile Patient Table with 4-way movement PRO-MT4
Mobile Patient Table with 6-way movement PRO-MT6
Fixed Patient Table PRO-FT
Fixed Patient Table with 4-way movement PRO-FT4
Fixed Patient Table with 6-way movement PRO-FT6 | | √ | √ |

6

Safety and effectiveness, comparison to predicate device:

This combination device has the same indications for use, is similar in technological characteristics to the predicate devices and employs already 510(k) cleared digital panels and software. In addition, most of the other components employed in the device have already been used in previously cleared 510(k) devices. The device has also been adequately tested to the relevant performance standards to prove that the integrated device is safe and effective for the intended use.

		Predicate	Predicate	Comparison
Comparable	Subject Device	Device 1	Device 2	Results
Properties		(K150816)	(K153119)
Intended Use	ProRad Series Stationary
Radiographic System is
intended for use by a
qualified, trained doctor or
technician on both adult and
paediatric 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.	Jumong Series
is 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
radiographic
systems are
intended for
use by a
qualified/train
ed physician
or technician
on both adult
and pediatric
subjects for
taking
diagnostic x-
rays. Not for
mammograp
hy,
angiography,
interventional
, or
fluoroscopy
use.	Equivalent
Comparable
Properties	Subject Device	Predicate
Device 1
(K150816)	Predicate
Device 2
(K153119)	Comparison
Results
Configuration
of Digital
Panels	Battery or AC operated
wireless IEEE 802.11n or
Wired Ethernet	Battery or AC
operated
wireless IEEE
802.11n or
Wired Ethernet	Battery or
AC operated
wireless
IEEE
802.11n or
Wired
Ethernet	Same
Digital Panel
Models and
their
Clearance
Numbers	CANON Flat Panel
detector CXDI-401C
Compact (K103591)
CANON Flat Panel
detector CXDI-410C
Wireless (K171270)
CANON Portable detector
CXDI-701C Wireless
(K131106)
CANON Portable detector
CXDI-710C Wireless
(K170332)
VAREX PAXSCAN
4343R v3 (K172951)
VAREX PAXSCAN
4336W v4 (K161459)
VAREX (PerkinElmer)
XRpad 4343F MED Flat
Panel Detector (K142698)
VAREX (PerkinElmer)
XRpad 4336 MED Flat
Panel Detector (K140551)
DRTECH EVS 4343, EVS
4343G Digital Flat Panel
X-ray Detector (K162555)
DRTECH EVS 3643, EVS
3643G Digital X-ray
detector (K162552)	Vieworks

Vivix-S
Wireless
(K122865)
Vivix-S with
Vxvue
(K122866)
Vivix-S
(K120020) | - VAREX
PAXSCAN
4343R
(K130318)
| Similar
functionality
(Note 1) |
| Image
Acquisition
Panel
Specification
S | 3,320 x 3,408 Pixels 125
µm (CXDI 401C
Compact)
3,320 x 3,408 Pixels 125
µm (CXDI 410C
Compact)
2,800 x 3,408 Pixels 125
µm (CXDI 701C) | FXRD-
1717SA,
FXRD-
1717SB)
3,072 x
3,072,
140µm or
FXRD-
1417SA, | 3,072 x
3,072 Pixels
139 µm
(PAXSCAN
4343R)
2,560 x
3,072 Pixels
139 µm | Similar
functionality
(Note 1) |
| Comparable
Properties | Subject Device | Predicate | Predicate | Comparison |
| | | Device 1 | Device 2 | Results |
| | | (K150816) | (K153119) | |
| | 2,800 x 3,408 Pixels 125
µm (CXDI 710C)
3,072 x 3,072 Pixels 139
µm (PAXSCAN 4343R
v3)
3,072 x 2,560 Pixels 139
µm (PAXSCAN 4336W
v4)
4,318 x 4,320 Pixels 100
µm (XRpad 4343F)
3,556 × 4,320 Pixels 100
µm (XRpad 4336)
3,072 x 3,072 Pixels 140
µm (EVS 4343, EVS
4343G)
2,560 x 3,072 Pixels 140
µm (EVS 3643, EVS
3643G) | FXRD-
1417SB)
2,560 x
3,072,
140µm
Wireless:
FXRD-
1417WA,
FXRD1417
WB, 2,560 x
3,072,
140µm | (PAXSCAN
4336R) | |
| DICOM | DICOM 3 | DICOM 3 | DICOM 3 | Same |
| WiFi
Wireless
IEEE802.11n
(All
others are
Ethernet
Tethered.) | CANON CXDI 701C
Wireless
VAREX PAXSCAN
4336W v4
PerkinElmer XRpad 4336
MED Flat Panel Detector
DRTECH EVS 3643, EVS
3643G Digital X-ray
detector | K122865 Vivix-
S Wireless | Wireless
detector- Not
applicable | Similar
functionality |
| Image
Acquisition
Software | CANON CXDI NE
(K153312, K171270)
DROC (Digital
Radiography Operator
Console) (K130883)
Econsole1 (K152172) | Vieworks
Vivix-S With
Vxvue
(K122866)
Vivix-S
(K120020) | ECOM
Software
(K130883) | Similar
functionality
(Note 2) |
| Power
Source | AC Line, various voltages
available | AC Line,
various voltages
available | AC Line | Same |
| X-ray
Generator | CPI CMP 200DR (32 kW, 40
kW, 50 kW, 65 kW, 80 kW)
(125 kV/150 kV for 32 kW, 40
kW)
(150kV for 50 kW, 65 kW, 80
kW) | CPI CMP200DR | CPI CMP
200DR HF,
150kV
(40kW,
50kW, 65
kW, 80 kW) | Same or
similar
functionality
(Note 3) |
| Comparable
Properties | Subject Device | Predicate
Device 1
(K150816) | Predicate
Device 2
(K153119) | Comparison
Results |
| X-ray Tubes | TOSHIBA
E7239FX: 125kV, LF2.0,
SF1.0, 140kHU
E7242FX:
125kV, LF1.5, SF0.6, 200kHU
E7252X: 150kV, LF1.2,
SF0.6, 300kHU
E7254X: 150kV, LF1.2,
SF0.6, 400kHU
E7869X: 150kV, LF1.2,
SF0.6, 600kHU
E7884X: 150kV, LF1.2,
SF0.6, 300kHU
E7843X: 150kV, LF1.2,
SF0.6,150kHU
VAREX
RAD14: 150kV, LF1.2, SF0.6,
300kHU
RAD60: 150kV, LF1.2, SF0.6,
400kHU
RAD92: 150kV, LF1.2, SF0.6,
600kHU | -- | CPI CMP
200DR HF,
125kV
(40kW)
150 kVp
0.6/1.2 mm
focal spots | Similar
functionality
(Note 4) |
| Collimator | Ralco R221, R225ACS
Deasung M38 | Ralco R225 | Collimare | Similar
functionality
(Note 5) |
| Performance
Standard | FDA 21 CFR 1020.30-31 | FDA 21 CFR
1020.30-31 | FDA 21 CFR
1020.30-31 | Same |
| Electrical
Safety | Electrical Safety as per IEC

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Electrical Safety

as per IEC
60601 | Electrical
Safety as per
IEC 60601 | Same |

Substantial equivalence:

7

8

9

Note	Description
Note 1	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 demonstrate that it does not raise the
level of safety concern and affect any effectiveness. The relevant 510(k)
approval numbers are K103591, K171270, K131106, K170332, K172951,
K161459, K142698, K140551, K162555 and K162552.

10

| Note 2 | Prognosys utilizes image processing software that has been previously
cleared by the FDA. The respective 510(k) approval numbers are K153312,
K171270, K130883 and K152172. Prognosys does not modify any
software utilized for image processing or display. |
|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 3 | In addition to the various power ratings of x-ray generators used by
predicate device, the subject device also utilizes a similar X-ray generator
with different power ratings which does not raise any level of safety concern
and affect any effectiveness; the generator frequency does affect the X-ray
exposure parameters. In addition, the X-ray generators used by the subject
device have also been used in previously cleared 510(k) devices with
approval numbers K150816 and K153119. |
| Note 4 | Both configurations (Toshiba and Varex) provide similar imaging resolution
on both focal spots. In addition, the X-ray tubes have been used in
previously cleared 510(k) devices with approval numbers K152767,
K173823, K103050 and K1881874. |
| Note 5 | The inherent filtration for the collimator in the subject device is different from
the predicate device; this difference does not affect the safety and
effectiveness. |

The ProRad series Stationary Radiographic System is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. This device utilizes previously cleared X-ray flat panel detectors and image processing software which are the main components of any X-Ray diagnostic system. The other components of the imaging system such as the X-Ray generator and X-Ray Tube are used in previously cleared 510(k) devices and are either identical or similar to the predicate devices. The remaining other components such as the Collimator, Mechanical Tube Stand, Mechanical Bucky Stand and Patient Table have no impact on the safety and effectiveness of the system. In addition, the subject device has been tested to the relevant performance standards as summarized below.

Summary of non-clinical testing:

The ProRad 2FC and ProRad 3NC Digital Stationary Radiographic Systems comply with the following standards:

. IEC 60601-1: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General ● requirements for basic safety Collateral standard: Electromagnetic compatibility requirements and tests

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IEC 60601-1-3: General requirements for basic safety and essential ● performance - Collateral Standard: Radiation protection in diagnostic Xray equipment
IEC 60601-2-54: Particular requirements for the basic safety and essential ● performance of X-ray equipment for radiography and radioscopy
IEC 60601-1-6: Medical electrical equipment Part 1-6: General ● requirements for basic safety and essential performance - Collateral standard: Usability
ISO 14971: Medical devices. Application of risk management to medical ● devices

Furthermore, cybersecurity concerns were addressed based on the US FDA Guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 2014" in the device labeling of these products.

Summary of clinical testing:

Since the digital x-ray panels and software have previously received FDA clearance, a clinical study was not required as per the FDA guidance document. The following information was not necessary to demonstrate substantial equivalence but provides additional support that the device works as intended. Clinical images acquired by the device were reviewed by a radiologist. The images were found to be acceptable and allowed the radiologist to make an accurate diagnosis.

Conclusion:

Technological differences from the predicate devices include different detectors, some with wireless functionality, different collimators and x-ray tubes. Although some of the components differ from the predicate devices, the detectors and other components have been cleared as part of other 510(k) submissions. Despite the few differences, after analysis of all test information, including the indications for use and test data, it can be concluded that the devices "ProRad 2FC and ProRad 3NC Stationary Radiographic Systems" are as safe and effective as the predicate devices, thus rendering them substantially equivalent to the predicate devices,