Who is the manufacturer of IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)?

Aspen Imaging Healthcare, Inc. filed the 510(k) submission for IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) (K241346).

What is the FDA product code for IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)?

MQB. It is classified under 21 CFR 892.1680 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)?

A1717MCW/A1417MCW/F1417MCV (K223930).

Who can help prepare an FDA 510(k) submission like IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)

K241346 · Aspen Imaging Healthcare, Inc. · MQB · Nov 7, 2024 · Radiology

Device Facts

Record ID	K241346
Device Name	IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
Applicant	Aspen Imaging Healthcare, Inc.
Product Code	MQB · Radiology
Decision Date	Nov 7, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1680
Device Class	Class 2
Attributes	Pediatric

Intended Use

The IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-Ray Detector) is indicated as a digital imaging solution designed for providing the general radiographic diagnosis of human anatomy targeting both adults and children. It is intended to replace film-based radiographic diagnostic systems. Not to be used for mammography.

Device Story

Digital flat panel X-ray detector; captures X-ray images for general radiography. Uses amorphous silicon (a-Si) TFT sensor with Cesium Iodide (CsI) scintillator to convert X-rays to digital signals. Supports wired or wireless (IEEE 802.11a/b/g/n/ac) communication. Features auto-trigger signal sensing (AED mode) for generator-independent operation. Used in clinical settings by healthcare professionals to replace film-based systems. AspenView software manages generator control, image acquisition, calibration, storage, and firmware. Output is a digital radiographic image for clinical diagnostic decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and imaging performance (DQE per IEC 62220-1-1).

Technological Characteristics

Amorphous silicon (a-Si) TFT sensor; Cesium Iodide (CsI) scintillator; 140um pixel pitch; 16-bit A/D conversion; 40-150kV energy range; IP54 rating; wired/wireless (IEEE 802.11a/b/g/n/ac) connectivity; AED and manual trigger modes. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 62220-1-1.

Indications for Use

Indicated for general radiographic diagnosis of human anatomy in adults and children. Not for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

A1717MCW/A1417MCW/F1417MCV (K223930)

Related Devices

K182551 — Wireless Digital Flat Panel Detector · Iray Technology Taicang , Ltd. · Oct 17, 2018
K223930 — A1417MCW/A1717MCW/F1417MCW · H&abyz Co., Ltd. · Mar 6, 2023
K242394 — Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) · Rayence Co., Ltd. · Sep 9, 2024
K230059 — Digital Flat Panel Detector · Ray Imaging Technology (Haining) Limited · Feb 3, 2023
K220559 — 17HQ901G-B · Lg Electronics.Inc · May 5, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 7, 2024 Aspen Imaging Healthcare Inc % Dave Kim Regulatory Affairs Consultant Mtech Group LLC 7505 Fannin St. Suite 610 HOUSTON, TX 77054 Re: K241346 Trade/Device Name: IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MOB Dated: May 6, 2024 Received: October 8, 2024 Dear Dave Kim: 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 (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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory {2}------------------------------------------------ assistance/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, Lu Jiang Lu Jiang, 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K241346 Device Name IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) Indications for Use (Describe) The IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-Ray Detector) is indicated as a digital imaging solution designed for providing the general radiographic diagnosis of human anatomy targeting both adults 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) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of {4}------------------------------------------------ FORM FDA 3881 (8/23) {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Aspen Imaging Healthcare. The logo consists of a stylized letter "A" on the left, followed by the words "ASPEN IMAGING" in a sans-serif font. Below "ASPEN IMAGING" is the word "HEALTHCARE" in a smaller, lighter font. The overall design is clean and modern. # 510(k) Summary K241346 # 1. Date Prepared [21 CFR 807.92(a)(a)] November 4, 2024 # 2. Submitter's Information [21 CFR 807.92(a)(1)] | Name of Manufacturer: | Aspen Imaging Healthcare Inc. | |-----------------------|------------------------------------------------| | Address: | 801 Jupiter Rd Suite 200, Plano, TX 75074, USA | | Contact Name: | Mr. Casey Lee, Vice President | | Telephone No.: | (+1) 214-257-0113 | | Email Address: | casey.lee@aspenimaging.com | # 3. Official Correspondent | Name: | Dave Kim, MBA | |----------|-------------------------------------------------------------------| | Address: | Mtech Group LLC 7505 Fannin St. Suite 610 Houston, TX 77054 | | Tel: | 1-713-467-2607 | | Email: | davekim@mtechgroupllc.com | ## 4. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] | Trade/Device/Model Name | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) | |-----------------------------|--------------------------------------------------------------------------| | 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 | {6}------------------------------------------------ SPEN IMAGING # 5. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate device within this submission is shown as follow; ### Predicate Device#1 | ● | 510(k) Number: | K223930 | |---|--------------------------------|---------------------------------| | ● | Applicant: | H&abyz Co., Ltd. | | ● | Detector Name: | A1717MCW/A1417MCW/F1417MCV | | ● | Common Name: | Digital Diagnostic X-ray System | | ● | Classification Name: | System. X-ray, Stationary | | ● | Regulation Number: | 21 CFR 892.1680 | | ● | Classification Product Code | MQB | | ● | Device Class: | II | - 510(k) Review Panel: Radiology # 6. Description of the Device [21 CFR 807.92(a)(4)] The IODR1717 / IODR1417 / IODR1417-GF detectors are wired or wireless digital flat panel detectors that have been designed for faster, more streamlined approach to digital radiography systems. The IODR1717 / IODR1417 / IODR1417-GF detectors utilize a combination of propriety TFT and scintillator (Csl), 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 IODR1717 / IODR1417 / IODR1417-GF 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 Csl. The response has the excellent linearity of a charge-integrating-biased photodiode. Aspen\View software includes the basic functionality: generator control, detector control, firmware, image acquisition, image calibration and correction, image storage. | Device Model Name | IODR1717 | IODR1417 | IODR1417-GF | |---------------------------|--------------------|--------------------|-------------| | Sensor Type | a-Si TFT | | | | Scintillator | CsI | | | | Total Pixel Number | 3072 x 3072 pixels | 2560 x 3072 pixels | | | Total Pixel Area | 430 x 430mm | 358.5 x 430mm | | | Effective Pixel Number | 3036 x 3040 pixels | 2466 x 3040 pixels | | | Effective Pixel Area | 425.04 x 425.6mm | 345.24 x 425.6mm | | | Pixel pitch | | 140um | | #### > Detector {7}------------------------------------------------ | Limiting Resolution | Max 3.57lp/mm | |---------------------|--------------------------------------------------------| | Energy Range | 40 ~ 150Kv | | A/D Conversion | 16 bits | | Wi-Fi | IEEE 802.11a/b/g/n/ac, 2.4GHz/5GHz | | IP Range | IP54 | | Communication | 1Giga-bit Ethernet | | Trigger Mode | Normal Mode AED Mode (Auto Exposure Detection Mode) | | Packing | 1 BOX | # 7. Indications for use [21 CFR 807.92(a)(5)] The IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-Ray Detector) is indicated as a digital imaging solution designed for providing the general radiographic diagnosis of human anatomy targeting both adults and children. It is intended to replace film-based radiographic diagnostic systems. Not to be used for mammography. # 8. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)] The technological characteristics of the subject devices are identical compared to the predicate devices. Provided below is a table summarizing and comparing the technological characteristics of The IODR1717 / IODR1417 / IODR1417-GF and the predicate device: | | Proposed Device | Predicate Device#1 | Note | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | K Number | K241346 | K223930 | - | | Manufacturer | Aspen Imaging Healthcare Inc. | H&abyz Co., Ltd. | - | | Detector Name | IODR1717 | A1717MCW | - | | Common Name | Digital Flat Panel X-ray Detector | Digital Flat Panel X-ray Detector | Same | | Product Code | MQB | MQB | Same | | Regulation Number | 21 CFR 892.1680 | 21 CFR 892.1680 | Same | | 510(k) Review Panel | Radiology | Radiology | Same | | Indications for Use | The IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-Ray Detector) is indicated as a digital imaging solution designed for providing the general radiographic diagnosis of human anatomy targeting both adults and children. It is intended to replace film-based radiographic diagnostic systems. Not to be used for mammography. | A1717MCW 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. | Same | | Scintillator | Csl | Csl | Same | #### [Table 1. Comparison of Proposed Device(IODR1717) to Predicate Devices] {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Aspen Imaging Healthcare. The logo consists of a stylized letter "A" on the left, followed by the words "ASPEN IMAGING" in a sans-serif font. Below "ASPEN IMAGING" is the word "HEALTHCARE" in a smaller, lighter font. The logo has a clean and modern design. | Effective Pixel Area | 425.04 x 425.6 mm | 425.04 x 425.6 mm | Same | |----------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|------| | Total Pixel Number | 3,072 x 3,072 pixels | 3,072 x 3,072 pixels | Same | | Pixel Pitch | 140um | 140um | Same | | High Contrast Limiting Resolution (LP/mm) | Max. 3.57 | Max. 3.57 | Same | | Communication | Wired/Wireless | Wired/Wireless | Same | | DQE | 69% (0.5lp/mm, min.) | 69% (0.5lp/mm, min.) | Same | | MTF | 97% (0.1lp/mm, min.) | 97% (0.1lp/mm, min.) | Same | | Anatomical Sites | General | General | Same | | Exposure Mode | Normal Mode (Manual), AED Mode (Auto Exposure Detection) | Normal Mode (Manual), AED Mode (Auto Exposure Detection) | Same | | Wireless | IEEE 802.11a/b/g/n/ac | IEEE 802.11a/b/g/n/ac | Same | # [Table 2. Comparison of Proposed Device(IODR 1417) to Predicate Devices] | | Proposed Device | Predicate Device#1 | Note | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | K Number | K241346 | K223930 | - | | Manufacturer | Aspen Imaging Healthcare Inc. | H&abyz Co., Ltd. | - | | Detector Name | IODR1417 | A1417MCW | - | | Common Name | Digital Flat Panel X-ray Detector | Digital Flat Panel X-ray Detector | Same | | Product Code | MQB | MQB | Same | | Regulation Number | 21 CFR 892.1680 | 21 CFR 892.1680 | Same | | 510(k) Review Panel | Radiology | Radiology | Same | | Indications for Use | The IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-Ray Detector) is indicated as a digital imaging solution designed for providing the general radiographic diagnosis of human anatomy targeting both adults and children. It is intended to replace film-based radiographic diagnostic systems. Not to be used for mammography. | A1417MCW (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. | Same | | Scintillator | Csl | Csl | Same | | Effective Pixel Area | 345.24 x 425.6 mm | 345.24 x 425.6 mm | Same | | Total Pixel Number | 2,560 x 3,072 pixels | 2,560 x 3,072 pixels | Same | {9}------------------------------------------------ | Pixel Pitch | 140um | 140um | Same | |----------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|------| | High Contrast Limiting Resolution (LP/mm) | Max. 3.57 | Max. 3.57 | Same | | Communication | Wired/Wireless | Wired/Wireless | Same | | DQE | 69% (0.5lp/mm, min.) | 69% (0.5lp/mm, min.) | Same | | MTF | 97% (0.1lp/mm, min.) | 97% (0.1lp/mm, min.) | Same | | Anatomical Sites | General | General | Same | | Exposure Mode | Normal Mode (Manual), AED Mode (Auto Exposure Detection) | Normal Mode (Manual), AED Mode (Auto Exposure Detection) | Same | | Wireless | IEEE 802.11a/b/g/n/ac | IEEE 802.11a/b/g/n/ac | Same | # [Table 3. Comparison of Proposed Device (IODR 1417-GF) to Predicate Devices] | | Proposed Device | Predicate Device#1 | Note | |----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | K Number | K241346 | K223930 | - | | Manufacturer | Aspen Imaging Healthcare Inc. | H&abyz Co., Ltd. | - | | Detector Name | IODR1417-GF | F1417MCW | - | | Common Name | Digital Flat Panel X-ray Detector | Digital Flat Panel X-ray Detector | Same | | Product Code | MQB | MQB | Same | | Regulation Number | 21 CFR 892.1680 | 21 CFR 892.1680 | Same | | 510(k) Review Panel | Radiology | Radiology | Same | | Indications for Use | The IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-Ray Detector) is indicated as a digital imaging solution designed for providing the general radiographic diagnosis of human anatomy targeting both adults and children. It is intended to replace film-based radiographic diagnostic systems. Not to be used for mammography. | F1417MCW (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. | Same | | Scintillator | Csl | Csl | Same | | Effective Pixel Area | 345.24 x 425.6 mm | 345.24 x 425.6 mm | Same | | Total Pixel Number | 2,560 x 3,072 pixels | 2,560 x 3,072 pixels | Same | | Pixel Pitch | 140um | 140um | Same | | High Contrast Limiting Resolution (LP/mm) | Max. 3.57 | Max. 3.57 | Same | {10}------------------------------------------------ | Communication | Wired/Wireless | Wired/Wireless | Same | |---------------------|----------------------------------------------------------------|----------------------------------------------------------------|------| | DQE | 71% (0.5lp/mm, min.) | 71% (0.5lp/mm, min.) | Same | | MTF | 98% (0.1lp/mm, min.) | 98% (0.1lp/mm, min.) | Same | | Anatomical Sites | General | General | Same | | Exposure Mode | Normal Mode (Manual), AED Mode (Auto Exposure Detection) | Normal Mode (Manual), AED Mode (Auto Exposure Detection) | Same | | Wireless | IEEE 802.11a/b/g/n/ac | IEEE 802.11a/b/g/n/ac | Same | # 9. Non-Clinical Test summary The IODR1717 / IODR1417 / IODR1417-GF comply with voluntary standards for electrical safety, electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination: #### 1) Electrical Safety, Electromagnetic Compatibility and Performance: The IODR1717 / IODR1417 / IODR1417-GF detectors comply with the electrical safety and electromagnetic compatibility requirements established by the standards. | Standards No. | Standard Title | Version | Publication Year | |-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------| | IEC 60601-1 | Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance | 2005/AMD2: 2020 | 2020 | | IEC 60601-1-2 | Medical Electrical Equipment - Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests | 60601-1-2 Edition 4.1 2014-02 | 2020 | | IEC 62220- 1-1 | Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging | 62220-1- 1 Edition 1.0 2015- 03 | 2015 | #### 2) Software Validation The IODR1717 / IODR1417 / IODR1417-GF contain 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 guidance: - The content of premarket submissions for software contained in 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 #1 in order to demonstrate adequate DQE performance of The IODR1717 / IODR1417 / IODR1417-GF detector. According to the above comparison table, subject device shows the same DQE as the predicate device. #### 5) Cybersecurity - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket . Submissions #### 6) Label - 21 CFR 1020.30, 1020.31 - Pediatric Information for X-ray Imaging Device Premarket Notifications {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Aspen Imaging Healthcare. The logo consists of a stylized letter A and I in dark blue on the left. To the right of the letters, the words "ASPEN IMAGING" are written in a dark gray sans-serif font, with the word "HEALTHCARE" written in a lighter gray below. #### 10. Clinical Test Summary Clinical data is no provided for this submission. ### 11. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] The IODR1717 / IODR1417 / IODR1417-GF are identical to the predicate device, K223930 and there is no change that would adversely affect the use of the product. It is substantially equivalent to these devices in indications for use and technology characteristics. ## 12. 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 IODR1717 / IODR1417-GF detectors are substantially equivalent in safety and effectiveness to the predicate device, K223930.