(46 days)
Not Found
No
The document describes a standard digital X-ray detector and its image capture process, with no mention of AI or ML technologies for image processing, analysis, or interpretation.
No.
The device is an X-ray detector used for diagnostic imaging, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for general radiographic diagnosis of human anatomy."
No
The device description clearly states it is a "flat-panel type digital X-ray detector" and describes its physical components and function in converting X-rays to digital signals, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The EXPD 86P, EXPD 86PG, EXPD 129PG Digital X-ray detector is a device that captures X-ray images of the human anatomy. This is an in vivo (within the body) imaging process, not an in vitro diagnostic test.
- Intended Use: The intended use clearly states "providing general radiographic diagnosis of human anatomy," which is a function of medical imaging, not laboratory testing of samples.
The device is a medical imaging device used for diagnostic purposes, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EXPD 86P, EXPD 86PG, EXPD 129PG Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
Product codes (comma separated list FDA assigned to the subject device)
MOB
Device Description
The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EXPD 86P, EXPD 129P, EXPD 129PG differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.
The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light. This visible light is then collected by an optical sensor, which generates an electric charges representation of the spatial distribution of the incoming X-ray quanta.
The charges are converted to a modulated electrical signal thin film transistors. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
General Radiography
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing confirming that the main physical values for comparison of X-ray devices like DQE and MTF are basically equal or worth than the predicate device. The device complies with several international and FDA-recognized consensus standards.
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.
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.
Not Found
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
§ 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.
0
November 18, 2022
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DRTECH Corporation % Ella An Regulatory Affairs Suite No. 1, 2 Floor/Suite No. 2, 3 Floor, 29, Dunchon-daero 541beon-gil Jungwon-gu, Seongnam-si, Gyeonggi-do 13216 KOREA
Re: K223124
Trade/Device Name: EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MOB Dated: September 29, 2022 Received: October 3, 2022
Dear Ella An:
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
1
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 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,
Zhkke
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223124
Device Name EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
Indications for Use (Describe)
The EXPD 86P, EXPD 86PG, EXPD 129PG Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
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) Number: K223124
DRTECH Corporation Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-Daero 541beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, South Korea
510(k) Summary
[As required by 21 CFR 807.92]
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92
1. Date Prepared [21 CFR 807.92(a) (1)]
September/29/2022
2. Submitter's Information [21 CFR 807.92(a) (1)]
| • Name of Sponsor: | DRTECH Corporation |
|---|---|
| • Address: | Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil |
| Jungwon-gu, Seongnam-si, Gyeonggi-do, South Korea |
- Contact Name: Ella An ●
- Telephone No.: + 82-31-779-7787
- Fax No .: + 82-31-779-7790
- Email Address : ● ysan96@drtech.co.kr
- Registration Number: ● 3005172103
- Name of Manufacturer: Same as Sponsor ●
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]
| • Trade Name: | EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG |
|---|---|
| --------------- | -------------------------------------------- |
- . Common Name: Digital Flat Panel X-ray Detector
- Classification Name: Stationary X-ray System ●
- Classification Panel: Radiology
- Classification Regulation: 21 CFR 892.1680 ●
- Product Code: MOB
- Device Class: II ●
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
- 510(k) Number: ● K192400
- Applicant: DRTECH Corporation
- Trade Name: EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG ●
- Classification Name: Stationary X-ray System ●
- Classification Panel: Radiology ●
- Classification Regulation: 21 CFR 892.1680
- Product Code: MQB ●
- Device Class: II ●
4
5. Description of the Modified Device [21 CFR 807.92(a) (4)]
Addition of EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG: The differences between the subject devices and the predicate devices are Dimension and Configuration of Components(Optional). The Dimension of Subject devices is longer than predicate devices.
6. Indication for Use [21 CFR 807.92(a)(5)]
The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EXPD 86P, EXPD 129P, EXPD 129PG differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.
The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light. This visible light is then collected by an optical sensor, which generates an electric charges representation of the spatial distribution of the incoming X-ray quanta.
The charges are converted to a modulated electrical signal thin film transistors. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.
Comparisons with the predicate, devices show the technological characteristics of the EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG to be same to the predicate devices. EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG is functionally identical to the predicate devices.
5
DRTECH
8. Intergrated Configuration for X-Ray system
The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG is connected with General diagnostic X-ray system.
Image /page/5/Figure/4 description: This image shows a diagram of an X-ray system setup. The diagram includes components such as an X-ray System Generator, EXPD129P, Console PC, and Hospital Network. Cables labeled as LLD POE Cable, Ethernet Cable, and LLD SYNC Cable connect these components, with annotations indicating voltage, Gigabit Ethernet, and bidirectional TTL signal specifications.
| No. | Cable | Communication |
|---|---|---|
| ① | LLD POE Cable | 1) DC 24V voltage |
- It is supplied from Adaptor to Detector. |
| ② | LLD POE Cable | 1) Gigabit Ethernet Communications - It is transmitted from the detector to the CONSOLE PC. |
| ③ | LLD SYNC Cable | 1) two-way TTL communication - It is communicated between the detector and the X-ray System Generator. |
| ④ | LAN Cable | 1) 1) DICOM communication - It is transmitted from the CONSOLE PC to the hospital network. |
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DRTECH
For successful integration of detector with X-ray system, we designed the hardware of EXPD 86P, EXPD 86PG, EXPD 129PG as below function. The Energy of generator is controlled by Radiography imaging software(Econsole1, K152172), not Detector.
| Mode | Description |
|---|---|
| AED/AWC Mode | The detector detects actual amount of X-rays without any connection to the X-ray |
| generator. | |
| No signal used (No need of connector interface cable) | |
| Sync. Trigger Mode | The detector receives EXP_REQ signal that X-ray generator is prepared to |
| generate X-rays. | |
| The detector prepares image acquiring and then responds EXP_OK signal to the | |
| X-ray generator. | |
| The X-ray generator confirms EXP_OK signal and generates X-ray, then the | |
| detector performs image acquiring, according to image acquisition time and | |
| transmits the image data. | |
| EXP_REQ (Generator→ Detector), EXP_OK (Detector →Generator) |
9. Substantial Equivalence [21 CFR 807.92(b)]
| Parameter | Subject Device | Predicate Device |
|---|---|---|
| 510(K) Number | Unknown | K192400 |
| Manufacturer | DRTECH Corporation | DRTECH Corporation |
| Model Name | EXPD 129P/ EXPD 129PG/ | |
| EXPD 86P/ EXPD 86PG | EVS 4343A / EVS 4343AG | |
| EVS 3643A / EVS 3643AG | ||
| Classification Name | Stationary X-ray System | |
| Classification Panel | Radiology | |
| Classification | ||
| Regulation | 21 CFR 892.1680 | |
| Product Code | MQB | |
| Device Class | Class II | |
| Intended Use | The EXPD 86P, EXPD 86PG, EXPD | |
| 129P, EXPD 129PG Digital X-ray | ||
| detector is indicated for digital imaging | ||
| solution designed for providing general | ||
| radiographic diagnosis of human | ||
| anatomy. This device is intended to | ||
| replace film or screen based | ||
| radiographic systems in all general | ||
| purpose diagnostic procedures. This | ||
| device is not intended for | ||
| mammography applications | The EVS 4343A / EVS 4343AG / EVS | |
| 3643A / EVS 3643AG Digital X-ray | ||
| detector is indicated for digital imaging | ||
| solution designed for providing general | ||
| radiographic diagnosis of human | ||
| anatomy. This device is intended to | ||
| replace film or screen based | ||
| radiographic systems in all general | ||
| purpose diagnostic procedures. This | ||
| device is not intended for | ||
| mammography applications. |
7
| Parameter | Subject Device | Predicate Device | ||
|---|---|---|---|---|
| Detector | ||||
| Size | EXPD 86P/ EXPD 86PG | |||
| : Rectangular Panel | EVS 3643A: Rectangular Panel | |||
| EVS 3643AG: Rectangular Panel | ||||
| EXPD 129P/ EXPD 129PG | ||||
| : 17" X 51" | EVS 4343A: 17" X 17" | |||
| EVS 4343AG: 17" X 17" | ||||
| EXPD 86P/ EXPD 86PG | ||||
| : 17" X 34" | EVS 3643A: 13" X 17" | |||
| EVS 3643AG: 13" X 17" | ||||
| Dimensions | EXPD 129P/EXPD 129PG | |||
| : 460mm (W) × 1324mm (L) × 20mm (H) [±0.5mm] | EVS 4343A: | |||
| 460(W) x 483(L) x 15.5(H) | ||||
| EVS 4343AG: | ||||
| 460(W) x 483(L) x 15.5(H) | ||||
| PD 86P/EXPD 86PG | ||||
| : 460mm (W) × 894.14mm (L) × 15.5mm (H) [±0.5mm] | EVS 3643A: | |||
| 460(W) × 409(L) × 15.5(H) | ||||
| EVS 3643AG: | ||||
| 460(W) × 409(L) × 15.5(H) | ||||
| Pixel Pitch | 140μm | 140μm | ||
| Image Size | EXPD 129P/EXPD 129PG | |||
| : 3,072 x 9,216 | EVS 4343A: 3,072 x 3,072 | |||
| EVS 4343AG: 3,072 x 3,072 | ||||
| EXPD 86P/EXPD 86PG | ||||
| : 3,072 x 6,144 | EVS 3643A: 2,560 x 3,072 | |||
| EVS 3643AG: 2,560 x 3,072 | ||||
| Scintillator & TFT | ||||
| Materials | TFT -amorphous Silicon | TFT -amorphous Silicon | ||
| EXPD 129P/ EXPD 86P: CsI | EVS 4343A/EVS 3643A: CsI | |||
| EXPD 129PG/ EXPD 86PG: Gadox | EVS 4343AG/ EVS 3643AG: GOS | |||
| Performance | DQE | EXPD 129P: 50.0 % at 0.5lp/mm | EVS 4343A: 52.9% at 1.0 lp/mm | |
| EXPD 129PG: 25.0 % at 0.5lp/mm | EVS 4343AG: 27.2 % at 1.0 lp/mm | |||
| EXPD 86P: 50.0 % at 0.5lp/mm | ||||
| EXPD 86PG: 25.0 % at 0.5lp/mm | EVS 3643A: 50.5 % at 1.0 lp/mm | |||
| EVS 3643AG: 26.3 % at 1.0 lp/mm | ||||
| MTF | EXPD 129P: 45.0 % at 2.0 lp/mm | |||
| EXPD 129PG: 45.0 % at 2.0 lp/mm | ||||
| EXPD 86P: 45.0 % at 2.0 lp/mm | ||||
| EXPD 86PG: 45.0 % at 2.0 lp/mm | EVS 4343A: 44.1 % at 2.0 lp/mm | |||
| EVS 4343AG: 49.2 % at 2.0 lp/mm | ||||
| EVS 3643A: 44.5% at 2.0 lp/mm | ||||
| EVS 3643AG: 46.3 % at 2.0 lp/mm | ||||
| Resolution | 3.5 lp/mm | 3.5 lp/mm | ||
| Anatomical Sites | General Radiography | General Radiography | ||
| Power Supply | 100 | 100 | ||
| Component | Adaptor & AC Power Cord | |||
| LLD POE Cable | ||||
| LLD Sync Cable | PoE Adaptor | |||
| Lan cables(2 ea) | ||||
| AC Power Cable | ||||
| Ethernet Connector Bracket | ||||
| Communication | Wired: Ethernet | Wired: Ethernet | ||
| Parameter | Modified Device | Predicate Device | Remark | |
| DOE | EXPD 129P: 50.0 % at 0.5lp/mm | EVS 4343A: 52.9 % at 1.0 lp/mm | ||
| EXPD 129PG: 25.0 % at 0.5lp/mm | EVS 4343AG: 27.2 % at 1.0 lp/mm | |||
| EXPD 86P: 50.0 % at 0.5lp/mm | EVS 3643A: 50.5 % at 1.0 lp/mm | |||
| EXPD 86PG: 25.0 % at 0.5lp/mm | EVS 3643AG: 26.3 % at 1.0 lp/mm | |||
| MTF | EXPD 129P: 45.0 % at 2.0 lp/mm | EVS 4343A: 44.1 % at 2.0 lp/mm | ||
| EXPD 129PG: 45.0 % at 2.0 lp/mm | EVS 4343AG: 49.2 % at 2.0 lp/mm | |||
| EXPD 86P: 45.0 % at 2.0 lp/mm | EVS 3643A: 44.5 % at 2.0 lp/mm | |||
| EXPD 86PG: 45.0 % at 2.0 lp/mm | EVS 3643AG: 46.3 % at 2.0 lp/mm |
DRTECH
8
When compared to the predicate devices (K192400), the EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG presented in this submission have similar:
- . Intended Use
- . Technological characteristics
- . Operating principle
- Performance (Resolution)
- Communication Method
- . Performance (DQE and MTF)
- . Panel Material
- . Software(Firmware)
A few differences are as follows
- . Size
- Configuration of Components(Optional)
There are no significant differences between the EXPD 86PG, EXPD 129P, EXPD 129PG and the predicate device(s) that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.
According to bench test report, it is proved that the DQE and MTF of predicated device and subject device are basically equal or worth than the predicate device. As a result, subject devices performance is equal or worth than the predicate device.
10. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]
The non-clinical performance testing constrains that the main physical values for comparison of Xray devices like DQE and MTF are basically equal or worth than the predicate device as following table:
The EXPD 86P / EXPD 86PG/ EXPD 129P/ EXPD 129PG detector complies with the following international and FDA-recognized consensus standards:
| Recognition No. | Standard No. | Title of Standard | Remark |
|---|---|---|---|
| ----------------- | -------------- | ------------------- | -------- |
9
| Recognition No. | Standard No. | Title of Standard | Remark |
|---|---|---|---|
| 19-46 | ANSI AAMI ES60601- | ||
| 1:2005/(R)2012 & A1:2012, | |||
| C1:2009/(R)2012 & | |||
| A2:2010/(R)2012 (Cons. Text) | |||
| [Incl. AMD2:2021] | Medical electrical equipment - Part 1: | ||
| General requirements for basic safety | |||
| and essential performance (IEC 60601- | |||
| 1:2005, MOD) [Including Amendment | |||
| 2 (2021)] | |||
| 12-289 | IEC 62220-1-1 Edition 1.0 2015-03 | Medical electrical equipment- | |
| Characteristics of digital X-ray imaging | |||
| devices Part 1-1: Determination of the | |||
| detective quantum efficiency Detectors | |||
| used in radiographic imaging | |||
| 5-125 | ISO 14971 Third Edition 2019-12 | Medical devices - Application of risk | |
| management to medical devices | |||
| 5-132 | IEC 60601-1-6 Edition 3.2 2020-07 | ||
| CONSOLIDATED VERSION | Medical electrical equipment - Part 1-6: | ||
| General requirements for basic safety | |||
| and essential performance - Collateral | |||
| standard: Usability | |||
| 12-342 | PS 3.1 - 3.20 2021e | Digital Imaging and Communications in | |
| Medicine (DICOM) Set | |||
| 19-36 | IEC 60601-1-2 Edition 4.1 2020-09 | ||
| CONSOLIDATED VERSION | Medical electrical equipment - Part 1-2: | ||
| General requirements for basic safety | |||
| and essential performance - Collateral | |||
| Standard: Electromagnetic disturbances |
- Requirements and tests | |
| 13-79 | IEC 62304 Edition 1.1 2015-06
CONSOLIDATED VERSION | Medical device software - Software life
cycle processes | |
DRTECH
11. Related FDA Guidance documents
We reviewed the below FDA guidance documents and it was reflected to development of the modified EXPD 86P/ EXPD 86PG/ EXPD 129P/ EXPD 129PG detector.
| Title of Guidance | Remark |
|---|---|
| Content of Premarket Submissions for Management of Cybersecurity in Medical Devices | |
| Pediatric Information for X-ray Imaging Device Premarket Notifications |
10
13. Conclusion [21 CFR 807.92(b)(3)]
The modified EXPD 86P / EXPD 86PG/ EXPD 129P/ EXPD 129PG detector is substantially equivalent to the currently marketed and predicate device (EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG - K192400) in terms of fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, Substantial equivalence was demonstrated through the non-clinical performance, which complied with the requirements specified in the international and FDA-recognized consensus standards, ANSI AAMI ES60601-1:2005/AMD2:2021, IEC 60601-1-2:2020, IEC 60601-1-6 Edition 3.2, IEC 62304:2015 and IEC 6220-1-1 which complied with the requirements specified in the CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.
The results of these tests demonstrate that The EXPD 86P / EXPD 86PG/ EXPD 129P/ EXPD 129PG meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, non-clinical performance data and safety testing demonstrates that the device is as safe, as effective, and performs as well or better than the predicate devices.