Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard digital radiography technology and image processing techniques (acquisition, correction, preprocessing) without mentioning any AI or ML components. The performance studies focus on standard imaging metrics and regulatory compliance, not AI/ML performance.

Therapeutic

No
This device is an X-ray detector used for diagnostic imaging, not for treating diseases or conditions.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "intended for digital imaging solution designed for providing general radiographic diagnosis of human anatomy." The term "diagnosis" clearly indicates a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device is a "digital flat panel detector" which is a hardware component. While it includes software for image processing, the core device is a physical detector.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states "digital imaging solution designed for providing general radiographic diagnosis of human anatomy". This describes a device used for in vivo imaging (imaging within the living body), not in vitro testing (testing outside the body, typically on biological samples like blood or urine).
Device Description: The description details a digital flat panel X-ray detector, which is a component of an X-ray imaging system used to capture images of the internal structures of the body.
Input Imaging Modality: The input modality is "Digital X-ray", which is an imaging technique applied to the patient, not a method for analyzing biological samples.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease. This device is used to create images of the human body itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ADD (Digital Flat Panel X-Ray Detector) is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems. Not to be used for mammography.

Product codes

MQB

Device Description

The ADD are wired or wireless digital flat panel detectors that have been designed for faster, more streamlined approach to digital radiography systems. The ADD detector utilize a combination of propriety TFT glass and scintillators(CsI), and those and electronics are housed in one package. The detectors support an auto-trigger signal sensing technology that allows the detectors to be used without generator integration.

The flat panel sensors of the ADD are fabricated using thin film technology based on amorphous silicon technology. Electronically, the sensors are much like conventional photodiode arrays. Each pixel in the array consists of a light-sensing photodiode and a switching Thin Film Transistor (TFT) in the same electronic circuit. Amorphous silicon photodiodes are sensitive to visible light, with a response curve roughly comparable to human vision. The sensitivity of amorphous silicon photodiodes peaks in green wavelengths, well matched to scintillators such as CsI. The response has the excellent linearity of a charge-integrating-biased photodiode.

SDK-MCW is the software of Detector that performs image acquisition, image correction, and preprocessing. According to the FDA quidance document entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," it has a moderate level of concern. Also, it does not base on previously-cleared software and was originally coded.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray

Anatomical Site

human anatomy, General

Indicated Patient Age Range

adult and children

Intended User / Care Setting

Not Found

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

Clinical data has been provided according to FDA guidance document "Guidance for the Submission of 510(k)s for Solid Sate X-ray Imaging Devices". Clinical images were provided; these images were not necessary to establish substantial equivalence based on the differences from the predicate (note TFT technology with CsI scintillator that is identical to the predicate image plate) but they provide further evidence in addition to the laboratory performance data to show that the subject digital detector works as intended.

Key Metrics

Not Found

Predicate Device(s)

K181631, K102349, K140771

Reference Device(s)

Not Found

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

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March 12, 2021

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 Department of Health & Human Services logo is a circular emblem with an abstract human figure. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

H&abyz Co., Ltd. % Im Do Gyun Senior Consultant GMS Consulting Co., Ltd. 34. Sangamsan-ro. Mapo-gu Seoul. 03909 KOREA

Re: K203188

Trade/Device Name: ADD Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: January 14, 2021 Received: January 29, 2021

Dear Im Do Gyun:

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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about medical devices and radiation-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

2

Indications for Use

510(k) Number (if known) K203188

Device Name ADD

Indications for Use (Describe)

ADD (Digital Flat Panel X-Ray Detector) is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems. Not to be used 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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510(K) Summary

4

510(k) Summary for K203188

[As Required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

March 02, 2021

2. Submitter's Information [21 CFR 807.92(a)(1)]

Name of Manufacturer: H&abyz Co. Ltd.
● Address: 1F, 2-Dong, 41-16 Cheoinseong-Ro, Namsa-Myeon, Cheoin-Gu, Yongin-Si, Gyeonggi-Do, Republic of Korea [17118] ● Contact Name: Namkyu Hur / Quality Manager
Telephone No.: +82 070-4658-9300
Email Address: hnk@abyzr.com
Registration No.: 3016674851

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

510(k) Number	K203188
Trade/Device/Model Name	ADD
Reference No.	HAD1417MCW
Common Name	Digital Flat Panel X-ray Detector
Device Classification Name	Stationary X-ray System
Regulation Number	21 CFR 892.1680
Classification Product Code	MQB
Device Class	II
510(k) Review Panel	Radiology

5

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate device within this submission are shown as follow;

Predicate Device#1

510(k) Number: K181631
Applicant: Samsung Electronics Co., Ltd.
Trade/Device Name: S4335-AW (of GR40CW)
Common Name: Digital Diagnostic X-ray System
Classification Name: System. X-ray, Stationary
Regulation Number: 21 CFR 892.1680
Classification Product MQB Code
Device Class: II
510(k) Review Panel: Radiology

Predicate Device#2

510(k) Number: K102349
Applicant: Konica Minolta Medical & Graphic, Inc.
Trade/Device Name: AeroDR SYSTEM
Common Name: Digital Diagnostic X-ray System
Classification Name: System. X-ray, Stationary
Requlation Number: 21 CFR 892.1680
Classification Product KPR Code
Device Class: II
510(k) Review Panel: Radiology

6

Predicate Device#3

Applicant:

●

510(k) Number: K140771
PHILIPS ELEVA WORKSPOT Trade/Device Name:

Philips Medical Systems DMC GmbH

Common Name: Digital Diagnostic X-ray System
Classification Name: System. X-ray, Stationary
Regulation Number: 21 CFR 892.1680
Classification Product MQB, LLZ Code
Device Class: II
510(k) Review Panel: Radiology

These predicate devices have not been subject to a design-related recall

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5. Description of the Device [21 CFR 807.92(a)(4)]

The ADD are wired or wireless digital flat panel detectors that have been designed for faster, more streamlined approach to digital radiography systems. The ADD detector utilize a combination of propriety TFT glass and scintillators(CsI), and those and electronics are housed in one package. The detectors support an auto-trigger signal sensing technology that allows the detectors to be used without generator integration.

The flat panel sensors of the ADD are fabricated using thin film technology based on amorphous silicon technology. Electronically, the sensors are much like conventional photodiode arrays. Each pixel in the array consists of a light-sensing photodiode and a switching Thin Film Transistor (TFT) in the same electronic circuit. Amorphous silicon photodiodes are sensitive to visible light, with a response curve roughly comparable to human vision. The sensitivity of amorphous silicon photodiodes peaks in green wavelengths, well matched to scintillators such as CsI. The response has the excellent linearity of a charge-integrating-biased photodiode.

SDK-MCW is the software of Detector that performs image acquisition, image correction, and preprocessing. According to the FDA quidance document entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," it has a moderate level of concern. Also, it does not base on previously-cleared software and was originally coded.

8

6. Indications for use [21 CFR 807.92(a)(5)]

ADD (Digital Flat Panel X-Ray Detector) is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic. Not to be used for manmography.

7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]

There are no significant differences in the technological characteristics of the predicate device which adversely affect safety or effectiveness. Provided below is a table summaring the technological characteristics of the ADD and the predicate device:

	Proposed Device	Predicate Device#1	Predicate Device#2	Predicate Device#3
K Number	K203188	K181631	K102349	K140771
Manufacturer	H&abyz Co., Ltd.	Samsung Electronics Co., Ltd.	KONICA MINOLTA MEDICAL &
GRAPHIC, INC	PHILIPS MEDICAL SYSTEMS
DMC GMBH
Trade Name	ADD	S4335-AW (of GR40CW)	AERODR SYSTEM	PHILIPS ELEVA WORKSPOT
Common Name	Digital Flat Panel X-ray Detector	Digital Flat Panel X-ray System	Digital Flat Panel X-ray Detector	Digital Flat Panel X-ray Detector
Product Code	MQB	MQB	KPR	MQB, LLZ
Regulation
Number	21 CFR 892.1680	21 CFR 892.1680	21 CFR 892.1680	21 CFR 892.1680
510(k) Review
Panel	Radiology	Radiology	Radiology	Radiology
Indications for
Use	ADD (Digital Flat Panel X-Ray
Detector) is indicated for digital
imaging solution designed for
providing general radiographic
diagnosis of human anatomy
targeting both adult and
children. It is intended to
replace film based radiographic
diagnostic systems. Not to be
used for mammography.	The GR40CW Digital X-ray
Imaging System is intended for
use in general projection
radiographic applications
wherever conventional screen-
film systems or CR systems may
be used. This device is not
intended for mammographic
applications.	The AeroDR SYSTEM is
indicated for use in generating
radiographic images of human
anatomy. It is intended to
replace radiographic film/screen
systems in general-purpose
diagnostic procedures. The
AeroDR SYSTEM is not indicated
for use in mammography,
fluoroscopy, tomography and
angiography applications.	As a part of a radiographic
system, the Philips Eleva
Workspot is intended to acquire,
process, store, display, and
export digital radiographic
images. The Philips Eleva
Workspot is suitable for all
routine radiography exams,
including specialist areas like
intensive care, trauma, or
pediatric work, excluding
fluoroscopy, angiography and
pediatric applications.
	Proposed Device	Predicate Device#1	Predicate Device#2	Predicate Device#3
				mammography.
Scintillator	CsI	CsI	CsI	CsI
Effective Pixel
Area	345.24 x 425.6 mm	345 x 425 mm	348.95 x 425.25 mm	426.3 x 432.0 mm
Total Pixel
Number	2,560 x 3,072 pixels	2,460 x 3,040 pixels	1,994 x 2,430 pixels	2,981 x 3,021 pixels
Pixel Pitch	140um	140 um	175um	143um
High Contrast
Limiting
Resolution
(LP/mm)	Max. 3.5	3.5	Not publicly available data	Not publicly available data
Communication	Wired/Wireless	Wired/Wireless	Wired/Wireless	Wired/Wireless
DQE	50% (0.1lp/mm, min.)	Typ.70% @0.1lp/mm	Typ. 40% @0.1lp/mm	Typ. 50% @0.1lp/mm
MTF	97% (0.1lp/mm, min.)	Typ.95% @ 0.1lp/mm	Typ.97% @ 0.1lp/mm	Typ.95% @ 0.1lp/mm
Anatomical	General	General	General	General
	Proposed Device	Predicate Device#1	Predicate Device#2	Predicate Device#3
Sites
Exposure Mode	Normal Mode (Manual),
AED Mode (Auto Exposure
Detection)	Manual, Auto (AED Mode)	Normal Mode (Manual),
AED Mode (Auto Exposure
Detection)	Normal Mode (Manual),
AED Mode (Auto Exposure
Detection)
Wireless	IEEE 802.11a/b/g/n	IEEE 802.11a/b/g/n	IEEE 802.11a	Not publicly available data

[Table 1. Comparison of Proposed Device to Predicate Devices]

9

10

The proposed device is substantially equivalent to the previously cleared detector provided as part of the complete imaging system.

It is substantially equivalent to these devices in design, funciples, and intended use. The proposed device, ADD has been tested about electrical safety, EMC, and the software has been validated. Also, the clinical data has been provided to support the substantial equivalence to the predicate device.

There are no significant differences between the ADD and the predicate devices that would adversely affect the nonclinical & clinical test results. (MTF & DQE specification of the predicate devices are provided by their user manual and literature) These differences do not raise different questions of safety and effectiveness than the predicate.

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8. Non-Clinical Test summary

The ADD complies with voluntary standards for electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:

Electrical Safety, Electromagnetic Compatibility and Performance:

The ADD complies with the electrical safety and electromagnetic compatibility requirements established by the standards.

| Standards
No. | Standards
Organization | Standard Title | Version | Publication
Year |
|------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------|
| ES60601-1 | AAMI ANSI | Medical Electrical Equipment - Part 1: General
Requirements for Basic Safety and Essential
Performance (IEC 60601-1:2005, MOD) | ES60601-1:
2005(R)201
2 and
A1:2012 | 2014 |
| 60601-1-2 | IEC | Medical Electrical Equipment - Part 1-2: General
Requirements for Safety – Collateral Standard:
Electromagnetic Compatibility - Requirements
and Tests | 60601-1-2
Edition 4.0
2014-02 | 2016 |
| - | FDA | Radio Frequency Wireless Technology in Medical
Devices | August 14 | 2013 |

2) Software Validation

The ADD contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA quidance:

The content of premarket submissions for software contained in medical devices, on May 11, 2005

3) Biocompatibility

ISO 10993-1 and series, Biological evaluation of medical devices

4) Performance Test

Imaging performance test has been conducted according to:

. IEC 62220-1, Medical Electrical Equipment – Characteristics of Digital X-ray Imaging Devices – Part 1-1: Determination of the Detective Quantum Efficiency – Detectors Used in Radiographic Imaging.
We select the predicate device #2 and #3 in order to demonstrate adequate DQE performance of the ADD detector. According to the above comparison table, subject device shows similar or better DQE.

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Cybersecurity

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, on October2, 2014

Label

CFR Part 801
Pediatric Information for X-ray Imaging Device Premarket Notifications, on November 28, ● 2017

9. Clinical Test Summary

Clinical data has been provided according to FDA guidance document "Guidance for the Submission of 510(k)s for Solid Sate X-ray Imaging Devices". Clinical images were provided; these images were not necessary to establish substantial equivalence based on the differences from the predicate (note TFT technology with CsI scintillator that is identical to the predicate image plate) but they provide further evidence in addition to the laboratory performance data to show that the subject digital detector works as intended

10. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

There are no significant differences between the ADD and the predicate device, K181631 that would adversely affect the use of the product. It is substantially equivalent to these devices in indications for use and technology characteristics.

11. Conclusion [21 CFR 807.92(b)(3)]

In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, concludes that the ADD is substantially equivalent in safety and effectiveness to the predicate device as described herein.