(28 days)
Not Found
No
The description focuses on the hardware and basic image acquisition/processing, with no mention of AI/ML terms or functionalities.
No
The device is an x-ray detector, used for imaging and diagnostic purposes, not for treating or curing a disease or condition.
Yes
Explanation: The device is an X-ray detector used in general projection radiographic applications to produce images. The clinical study confirmed that the device provides images of equivalent diagnostic capability to a predicate device, indicating its use in diagnosing medical conditions.
No
The device description explicitly details hardware components like a wired digital flat panel x-ray detector, TFT glass, scintillator, photodiode, Read Out IC, and A/D converter. While it includes software for image acquisition, storage, and viewing, it is fundamentally a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general projection radiographic applications". This involves imaging the internal structures of the body using X-rays, which is an in vivo (within a living organism) process, not in vitro (outside of a living organism, typically involving samples like blood or tissue).
- Device Description: The description details how the device captures X-ray images of the body.
- Input Imaging Modality: The input modality is X-ray, which is used for imaging the body directly.
IVD devices are used to examine specimens (like blood, urine, or tissue) obtained from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such functions.
N/A
Intended Use / Indications for Use
Digital Flat Panel X-ray Detector, HAD1717MC is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used. This device is not intended for mammographic applications.
Product codes
MQB
Device Description
This is a wired digital flat panel x-ray detector, a fast and efficient digital radiography system. The detector is used in combination with a TFT glass and scintillator (CSI) and supports automatic trigger signal detection technology that can be used without generator integration.
The incident X-rays are converted into visible light that produces electron hole pairs in a photometer biased by scintillator material. The charge carier is stored in the photodiode capacity. By pulse processing the gates of the TFT lines in the matrix, charges in all the columns are transferred in parallel with the signal output. All signals on the column are amplified by a custom Read Out IC for further processing.
The amplified signal is digitized using an A / D converter integrated into the ROIC. The digitized signal is transmitted to the PC. The device software is new software. When transferred to a PC, the software can acquire and store digitized images and view the images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Non-clinical testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 6220-1. All test results were satisfying with the IEC6220-1 standards.
In clinical data, clinical images were obtained in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. The study confirmed that the subject x-ray detector provides images of equivalent diagnostic capability to the predicate device and its results demonstrate similar equivalence or slightly better.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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January 31, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue.
H&abyz % Mrs. April Lee Consultant Withus Group, Inc. 106 Superior IRVINE CA 92620
Re: K200018
Trade/Device Name: HAD1717MC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: December 27, 2019 Received: January 3, 2020
Dear Mrs. Lee:
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
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) K200018
Device Name HAD1717MC
Indications for Use (Describe)
Digital Flat Panel X-ray Detector, HAD1717MC is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used. This device is not intended for mammographic applications.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Per 21 CFR 201.66; Select One) | ☐ Over-The-Counter Use (21 CFR 201.66; Select One) |
|---|---|
| ---------------------------------------------------------------------------------------------------- | ---------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for H&abyz. The logo consists of a colorful flower-like graphic on the left and the company name "H&abyz" in a dark gray sans-serif font on the right. The flower graphic has four petals in different colors: green, red, purple, and orange.
H&abyz
1F, 2-dong, 41-16, Cheoinseong-ro, Namsa-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea, 17118 Tel: +82-70-4658-9306
510(k) Summary - K200018
Submitter
H&abyz Nam Kyu Hur 1F, 2-dong, 41-16, Cheoinseong-ro, Namsa-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do, 17118 Republic of Korea Email: hnk@abyzr.com Phone: +82-70-4658-9306
Device Information
- Trade Name: HAD1717MC
- Classification Name: Stationary X-Ray System ●
- Common Name: Digital Flat Panel X-ray Detector ●
- Product Code: MQB ●
- Panel: Radiology
- Regulation Number: 892.1680 ●
- Device Class: Class II ●
- Date prepared: 01/22/2020
Primary Predicate Device
- K number: K152094 ●
- Trade Name: GR40CW .
- Classification Name: Stationary X-Ray System
- Common Name: Digital Flat Panel X-ray Detector ●
- Product Code: MQB
- Panel: Radiology
- Regulation Number: 892.1680 ●
Device Description
This is a wired digital flat panel x-ray detector, a fast and efficient digital radiography system. The detector is used in combination with a TFT glass and scintillator (CSI) and supports automatic trigger signal detection technology that can be used without generator integration.
The incident X-rays are converted into visible light that produces electron hole pairs in a photometer biased by scintillator material. The charge carier is stored in the photodiode capacity. By pulse processing the gates of the TFT lines in the matrix, charges in all the columns are transferred in parallel with the signal output. All signals on the column are amplified by a custom Read Out IC for further processing.
The amplified signal is digitized using an A / D converter integrated into the ROIC. The digitized signal is transmitted to the PC. The device software is new software. When transferred to a PC, the software can acquire and store digitized images and view the images.
Indications for use
Digital Flat Panel X-ray Detector, HAD1717MC 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.
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Image /page/4/Picture/0 description: The image shows the logo for H&abyz. The logo consists of a colorful flower-like graphic on the left and the text "H&abyz" on the right. The flower graphic has five petals in different colors: red, green, purple, and orange. The text is in a simple, sans-serif font and is colored in a dark gray.
1F, 2-dong, 41-16, Cheoinseong-ro, Namsa-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea, 17118 Tel: +82-70-4658-9306
Summary of Technological Characteristics
| Subject Device | Primary Predicate | |
|---|---|---|
| Manufacturer | H&abyz | Samsung Electronics Co., Ltd. |
| 510(k) Number | NA | K152094 |
| Model | HAD1717MC | GR40CW |
| Indications for Use | Digital Flat Panel X-ray Detector, | |
| HAD1717MC 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 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. | ||
| Appearance | Image: Subject Device Appearance | Image: Primary Predicate Appearance |
| Detector | ||
| Panel Type | a-Silicon, TFT | a-Silicon, TFT |
| Scintillator | CsI | CsI |
| Detector Area | 17 X 17 inches (427 x 427mm) | 17 X 17 inches (425mm X 425mm) |
| Pixel Pitch (µm) | 140 | 140 |
| High Contrast Limiting | ||
| Resolution(LP/mm) | 3.5 | 3.5 |
| DQE | TYP. 70% at 0.1 lp | TYP. 70% at 0.1 lp |
| MTF | TYP. 95% at 0.1 lp | TYP. 95% at 0.1 lp |
| Imaging Workstation | ||
| CPU | Intel Core 2 | Intel® Xeon® E5-1620 |
| Memory (RAM) | 4GB | 8GB |
| Storage (HDD) | 500GB | 1TB |
| Monitor | 1,920 x 1,080 pixels | 21 inch (1,920 X1,080) |
| CIB(Control Interface Box) | ||
| Max. Signal Input | ||
| Voltage | N/A | 400V DC/AC |
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Image /page/5/Picture/0 description: The image shows the logo for H&abyz. The logo consists of a colorful flower-like graphic on the left and the text "H&abyz" on the right. The flower graphic has four petals in red, green, purple, and orange. The text is in a dark gray color.
H&abyz
1F, 2-dong, 41-16, Cheoinseong-ro, Namsa-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea, 17118 Tel: +82-70-4658-9306
| Similarities | The subject and predicate devices are same and similar in indications, design,
technology, functions, and principle of operation. | | | | |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Differences | Detector
Area | As the imaging area and number of pixels is calculated by effective
pixels, there may have some differences. However, this difference
does not raise different questions of safety and effectiveness than
the predicate. | | | |
| | CPU | Subject medical device CPU has faster processing speed than the
predicate device's CPU, and the faster processing speed does not
contribute any adverse impacts to the device's safety and
performance. | | | |
| | Memory
(RAM) | Subject medical device memory size is smaller than the predicate
device's memory size, and the memory size does not contribute
any adverse impacts to the device's safety and performance. | | | |
| | Storage
(HDD) | Subject medical device Storage has smaller capacity than the
predicate device's Storage, and the small capacity does not
contribute any adverse impacts to the device's safety and
performance. | | | |
| | Max. Signal
Input
Voltage | Subject medical device uses the TRIGGER line instead of the CIB.
The CIB is managed by the x-ray system. The CIB only carries the
signal, and the HAD1717MC's Trigger cable also carries the signal.
Therefore, this difference does not raise different questions of
safety and effectiveness than the predicate. | | | |
Non-clinical Testing
- Electrical Safety and Electromagnetic Compatibility
Electrical, mechanical, environmental safety and performance testing were conducted according to standard ES 60601-1(2006/A1:2013), and EMC testing was conducted according to IEC 60601-1-2(2015). All test results were satisfying with the standards.
2) Performance data
Non-clinical testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 6220-1. All test results were satisfying with the IEC6220-1 standards.
Clinical Data
In clinical data, clinical images were obtained in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. The study confirmed that the subject x-ray detector provides images of equivalent diagnostic capability to the predicate device and its results demonstrate similar equivalence or slightly better.
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification H&abyz concludes that Digital Flat Panel X-ray Detector is similar equivalent in comparison with the predicate device as described herein.