Elements of

Predicate Device 1 Predicate Device 2 Reference Device

Comparison
TECHNICAL SPECIFICATION

Manufacture Varian Innocare H&abyz Co., Ltd.

Housing Material: Aluminum Housing Material: Mg-Al alloy Housing Material: Aluminum
Material Sensor Protection: Carbon fiber Sensor Protection: Carbon fiber Sensor Protection: Carbon fiber
and aluminum and aluminum and aluminum

The detector is used in The detector is used in

The detector is used in
combination with a TFT glass and combination with a TFT glass and
combination with a TFT glass and
scintillator (CSI) and supports scintillator (CSI) and supports
Device Description scintillator (GOS) and supports
automatic trigger signal automatic trigger signal
automatic trigger signal detection
detection technology that can be detection technology that can be
technology that can be used
used without generator used without generator
without generator integration.
integration. integration.

Brand Name N/A N/A N/A

Model Number
V17 HAD1717MC,
PaxScan® 4343RC HAD1717MG
17 inch wired X-ray detector
 · Detector type: Amorphous
· Detector type: Amorphous
Silicon, TFT
· Detector type: Amorphous Silicon, TFT
· Scintillator: HAD1717MC- Csi,
Silicon, TFT · Scintillator: GDX
HAD1717MG - GDX
· Scintillator: Csi · Imaging Area: 17 x 17 inches
· Imaging Area: 17 x 17 inches
· Imaging Area: 17 x 17 inches · Pixel Metrix: 3072 x 3072
· Pixel Metrix: 3072 x 3072
· Pixel Metrix: 3072 x 3072 · Active area: 427 x 427mm
Specification · Active area: 427 x 427mm
· Active area: 42.4 x 42.4mm · Pixel pitch: 140um
· Pixel pitch: 140um
· Pixel pitch: 139um · Resolution: 3.4lp/mm
· Resolution: 3.5lp/mm
· Resolution: 3.6lp/mm · A/D conversion: 16 bit
· A/D conversion: 14/16 bit
· A/D conversion: 16 bit · Data output: RAW (The RAW
· Data output: RAW (The RAW
· Data output: Gigabit Ethernet files are convertible into DICOM
files are convertible into DICOM
· Wired/Wireless: Wired 3.0 by console S/W)
3.0 by console S/W)
· Wired/Wireless: Wired
· Wired/Wireless: Wired

Sterilization N/A N/A N/A

Label As per ISO 13485: 2016 As Per ISO 13485: 2016 As Per ISO 13485: 2016
Mechanical testing N/A N/A N/A

Standards IEC/EN 60601-1 IEC/EN 60601-1 IEC/EN 60601-1

IEC/EN 60601-1-2 IEC/EN 60601-1-2 IEC/EN 60601-1-2

CLINICAL SPECIFICATION

It is intended to replace film- It is intended to replace film- It is intended to replace film-

based radiographic diagnostic based radiographic diagnostic based radiographic diagnostic
Medical indication systems and provide more systems and provide more systems and provide more
precise case diagnoses for precise case diagnoses for precise case diagnoses for
physicians and radiologists. physicians and radiologists. physicians and radiologists.
 ICD-10 Code: R00-R99 ICD-10 Code: R00-R99 ICD-10 Code: R00-R99
Clinical Condition Abnormal findings on diagnostic Abnormal findings on diagnostic Abnormal findings on diagnostic
imaging and in function studies, imaging and in function studies, imaging and in function studies,
without diagnosis. without diagnosis. without diagnosis.

Clinical Evaluation CE Certificate CE Certificate FDA & CE Certificate

Clinical literature None None None

Current knowledge
Current knowledge Current knowledge Current knowledge
/ state of art

Local regulations should be Local regulations should be Local regulations should be

reviewed before using those who reviewed before using those who reviewed before using those who
have limitations in X-rays due to have limitations in X-rays due to have limitations in X-rays due to
health issues. Make sure to check health issues. Make sure to check health issues. Make sure to check
Contraindication the conditions of X-ray irradiation the conditions of X-ray irradiation the conditions of X-ray irradiation
in advance. in advance. in advance.
Not to be used for Not to be used for Not to be used for
mammography. mammography. mammography.
Not to be used for infant and Not to be used for infant and Not to be used for infant and
pregnant women. pregnant women. pregnant women.

Expected clinical
Acquire X-ray images. Acquire X-ray images. Acquire X-ray images.
effect
 Body parts (such as head, Body parts (such as head, Chest, Body parts (such as head,
Site of the body Chest, spinal, abdominal, spinal, abdominal, particular, Chest, spinal, abdominal,
particular, hand, foot) hand, foot) particular, hand, foot)

Age: Adult and Children Age: Adult and Children Age: Adult and Children
(except infants) (except infants) (except infants)
Weight: Not relevant Weight: Not relevant Weight: Not relevant
Target population Gender: Not relevant Gender: Not relevant Gender: Not relevant
Health: Not relevant Health: Not relevant Health: Not relevant
Nationality: Not relevant Nationality: Not relevant Nationality: Not relevant
Patient state: Except pregnant Patient state: Except pregnant Patient state: Except pregnant
women women women

Duration of use less than 10 minutes less than 10 minutes less than 10 minutes

Digital Flat Panel X-ray Digital Flat Panel X-ray

Detector is indicated for Detector is indicated for
Digital Flat Panel X-ray Detector
digital imaging solution digital imaging solution
is indicated for digital imaging
designed for providing designed for providing
solution designed for providing
general radiographic general radiographic
general radiographic diagnosis
diagnosis of human anatomy diagnosis of human
of human anatomy targeting
targeting both adult and anatomy targeting both
Intended purpose both adult and children. It is
children. It is intended to adult and children. It is
intended to replace film based
replace film based intended to replace film
radiographic diagnostic systems
radiographic diagnostic based radiographic
and provide more precise case
systems and provide more diagnostic systems and
diagnosis for physicians and
precise case diagnosis for provide more precise case
radiologists. Not to be used for
physicians and radiologists. diagnosis for physicians and
mammography.
Not to be used for radiologists. Not to be used
mammography. for mammography.

Environment of
X-ray room X-ray room X-ray room
use
 BIOLOGICAL SPECIFICATION

Biocompatibility N/A N/A N/A

Animal testing N/A N/A N/A

Conclusion: According to the comparison contents, our product has equivalence regarding Technical, Clinical, Performance, Biological, Safety,
Appearance and intended purpose. Our products have the same design features and intended use as predicate device.