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 Description

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.

AI/ML Overview

The Aspen Imaging Healthcare IODR1717 / IODR1417 / IODR1417-GF Digital Flat Panel X-ray Detectors are evaluated against a predicate device (K223930). This submission focuses on demonstrating substantial equivalence based on technological characteristics and performance, rather than a clinical study with specific acceptance criteria on diagnostic accuracy for an AI-powered device.

Here's an analysis of the provided text in relation to your request, with the caveat that this is a hardware device (digital X-ray detector) and not an AI algorithm for diagnosis. Therefore, many of your requested points, especially those related to AI effectiveness, human reader improvement, and expert-established ground truth for a diagnostic test set, are not directly applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The submission establishes substantial equivalence by comparing the proposed device's performance characteristics to a legally marketed predicate device (K223930). The "acceptance criteria" here are implicitly that the proposed device's reported performance metrics are equivalent to or better than the predicate device.

Performance Metric	Acceptance Criteria (Predicate Device K223930)	Reported Device Performance (IODR1717)	Reported Device Performance (IODR1417)	Reported Device Performance (IODR1417-GF)
Scintillator	CsI	CsI	CsI	CsI
Effective Pixel Area (IODR1717)	425.04 x 425.6 mm	425.04 x 425.6 mm	N/A	N/A
Total Pixel Number (IODR1717)	3,072 x 3,072 pixels	3,072 x 3,072 pixels	N/A	N/A
Effective Pixel Area (IODR1417/GF)	345.24 x 425.6 mm	N/A	345.24 x 425.6 mm	345.24 x 425.6 mm
Total Pixel Number (IODR1417/GF)	2,560 x 3,072 pixels	N/A	2,560 x 3,072 pixels	2,560 x 3,072 pixels
Pixel Pitch	140um	140um	140um	140um
High Contrast Limiting Resolution (LP/mm)	Max. 3.57	Max. 3.57	Max. 3.57	Max. 3.57
Communication	Wired/Wireless	Wired/Wireless	Wired/Wireless	Wired/Wireless
DQE (0.5lp/mm, min.) - IODR1717/IODR1417	69%	69%	69%	N/A (listed separately for IODR1417-GF only)
DQE (0.5lp/mm, min.) - IODR1417-GF	71%	N/A	N/A	71%
MTF (0.1lp/mm, min.) - IODR1717/IODR1417	97%	97%	97%	N/A (listed separately for IODR1417-GF only)
MTF (0.1lp/mm, min.) - IODR1417-GF	98%	N/A	N/A	98%
Anatomical Sites	General	General	General	General
Exposure Mode	Normal Mode (Manual), AED Mode	Normal Mode (Manual), AED Mode	Normal Mode (Manual), AED Mode	Normal Mode (Manual), AED Mode
Wireless	IEEE 802.11a/b/g/n/ac	IEEE 802.11a/b/g/n/ac	IEEE 802.11a/b/g/n/ac	IEEE 802.11a/b/g/n/ac

2. Sample size used for the test set and the data provenance

The document states that "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." This standard describes methods for laboratory testing of detector performance, using phantoms and controlled X-ray beams. It is not equivalent to a clinical test set with patient data.

Therefore, there is no information about a "test set" in the context of clinical images or patient data. The provenance of such clinical data (e.g., country of origin, retrospective/prospective) is not provided because such a test set was not used for this type of device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As this is a hardware device (digital X-ray detector) and not an AI-powered diagnostic algorithm, there was no clinical test set requiring expert interpretation or ground truth establishment in the diagnostic sense. The performance tests (DQE, MTF, resolution) are objective physical measurements.

4. Adjudication method for the test set

Not applicable, for the same reasons as point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-powered diagnostic device, and no MRMC study was conducted or mentioned. The submission is for an X-ray detector, which is a component rather than a diagnostic interpretation system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is geared towards AI/software. The IODR devices are digital flat panel X-ray detectors. They are hardware components for X-ray imaging. While they include "Aspen\View software" for "generator control, detector control, firmware, image acquisition, image calibration and correction, image storage", this software pertains to the operation and image processing of the detector itself, not diagnostic analysis or algorithms to be used standalone for diagnosis. Therefore, a standalone performance study in the sense of an algorithm for diagnostic interpretation was not done.

7. The type of ground truth used

The "ground truth" for the performance tests (DQE, MTF, resolution) is based on physical measurements using phantoms and standardized protocols as defined by IEC 62220-1-1. This is a technical standard for evaluating the intrinsic image quality characteristics of the detector, not pathological or clinical outcomes data.

8. The sample size for the training set

Not applicable. This is not an AI algorithm that requires a training set. The device itself is hardware.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI algorithm.

Summary

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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.

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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

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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

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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)

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)

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FORM FDA 3881 (8/23)

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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 LLC7505 Fannin St. Suite 610Houston, 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 FlatPanel 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

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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 ProductCode	MQB
●	Device Class:	II

510(k) Review Panel: Radiology

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

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
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 PixelNumber	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

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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 ModeAED Mode (Auto Exposure Detection Mode)
Packing	1 BOX

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

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
RegulationNumber	21 CFR 892.1680	21 CFR 892.1680	Same
510(k) ReviewPanel	Radiology	Radiology	Same
Indications forUse	The IODR1717 / IODR1417 /IODR1417-GF (Digital FlatPanel X-Ray Detector) isindicated as a digital imagingsolution designed forproviding the generalradiographic diagnosis ofhuman anatomy targetingboth adults and children. It isintended to replace film-basedradiographic diagnosticsystems. Not to be used formammography.	A1717MCW is indicated fordigital imaging solution designedfor providing generalradiographic diagnosis of humananatomy targeting both adult andchildren. It is intended to replacefilm based radiographicdiagnostic systems. Not to beused for mammography.	Same
Scintillator	Csl	Csl	Same

[Table 1. Comparison of Proposed Device(IODR1717) to Predicate Devices]

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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 PixelArea	425.04 x 425.6 mm	425.04 x 425.6 mm	Same
Total PixelNumber	3,072 x 3,072 pixels	3,072 x 3,072 pixels	Same
Pixel Pitch	140um	140um	Same
High ContrastLimitingResolution(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
AnatomicalSites	General	General	Same
Exposure Mode	Normal Mode (Manual),AED Mode (Auto ExposureDetection)	Normal Mode (Manual),AED Mode (Auto ExposureDetection)	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
RegulationNumber	21 CFR 892.1680	21 CFR 892.1680	Same
510(k) ReviewPanel	Radiology	Radiology	Same
Indications forUse	The IODR1717 / IODR1417 /IODR1417-GF (Digital FlatPanel X-Ray Detector) isindicated as a digital imagingsolution designed for providingthe general radiographicdiagnosis of human anatomytargeting both adults andchildren. It is intended toreplace film-based radiographicdiagnostic systems. Not to beused for mammography.	A1417MCW (Digital Flat PanelX-Ray Detector) is indicated fordigital imaging solution designedfor providing generalradiographic diagnosis of humananatomy targeting both adult andchildren. It is intended to replacefilm based radiographicdiagnostic systems. Not to beused for mammography.	Same
Scintillator	Csl	Csl	Same
Effective PixelArea	345.24 x 425.6 mm	345.24 x 425.6 mm	Same
Total PixelNumber	2,560 x 3,072 pixels	2,560 x 3,072 pixels	Same

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Pixel Pitch	140um	140um	Same
High ContrastLimitingResolution(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
AnatomicalSites	General	General	Same
Exposure Mode	Normal Mode (Manual),AED Mode (Auto ExposureDetection)	Normal Mode (Manual),AED Mode (Auto ExposureDetection)	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
RegulationNumber	21 CFR 892.1680	21 CFR 892.1680	Same
510(k) ReviewPanel	Radiology	Radiology	Same
Indications forUse	The IODR1717 / IODR1417 /IODR1417-GF (Digital FlatPanel X-Ray Detector) isindicated as a digital imagingsolution designed for providingthe general radiographicdiagnosis of human anatomytargeting both adults andchildren. It is intended toreplace film-basedradiographic diagnosticsystems. Not to be used formammography.	F1417MCW (Digital Flat PanelX-Ray Detector) is indicated fordigital imaging solution designedfor providing generalradiographic diagnosis of humananatomy targeting both adult andchildren. It is intended to replacefilm based radiographicdiagnostic systems. Not to beused for mammography.	Same
Scintillator	Csl	Csl	Same
Effective PixelArea	345.24 x 425.6 mm	345.24 x 425.6 mm	Same
Total PixelNumber	2,560 x 3,072 pixels	2,560 x 3,072 pixels	Same
Pixel Pitch	140um	140um	Same
High ContrastLimitingResolution(LP/mm)	Max. 3.57	Max. 3.57	Same

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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
AnatomicalSites	General	General	Same
Exposure Mode	Normal Mode (Manual),AED Mode (Auto ExposureDetection)	Normal Mode (Manual),AED Mode (Auto ExposureDetection)	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	PublicationYear
IEC 60601-1	Medical Electrical EquipmentPart 1: General requirements for basic safety andessential performance	2005/AMD2:2020	2020
IEC 60601-1-2	Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety – Collateral Standard:Electromagnetic Compatibility - Requirements andTests	60601-1-2Edition 4.12014-02	2020
IEC 62220-1-1	Medical electrical equipment-Characteristics ofdigital X-ray imaging devices Part 1-1:Determination of the detective quantum efficiencyDetectors used in radiographic imaging	62220-1-1 Edition1.0 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

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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.

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.