K Number
K241346
Device Name
IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
Date Cleared
2024-11-07

(178 days)

Product Code
Regulation Number
892.1680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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.
More Information

Not Found

No
The summary describes a standard digital X-ray detector and associated software for image acquisition and processing, with no mention of AI or ML capabilities.

No
Explanation: The device is described as a "Digital Flat Panel X-Ray Detector" intended for "providing the general radiographic diagnosis of human anatomy." It "is intended to replace film-based radiographic diagnostic systems." This indicates its use for diagnosis (imaging) rather than treatment (therapy).

Yes

The device is explicitly indicated for "providing the general radiographic diagnosis of human anatomy."

No

The device description explicitly states that the device is a "digital flat panel X-Ray Detector" which is a hardware component. While it includes software ("Aspen\View software"), it is not solely 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 "providing the general radiographic diagnosis of human anatomy targeting both adults and children." This describes a medical imaging device used for visualizing internal structures of the body.
  • Device Description: The description details a digital flat panel X-ray detector that captures X-ray images. This is consistent with medical imaging equipment, not devices used to examine specimens from the human body.
  • Input Imaging Modality: The input modality is X-ray, which is a form of radiation used for imaging, not for analyzing biological samples.
  • Anatomical Site: The device targets "general radiographic diagnosis of human anatomy," indicating it's used on the patient's body.
  • Performance Studies: The performance studies focus on imaging characteristics like DQE, MTF, and resolution, which are relevant to image quality in medical imaging.

IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or treatment. This device does not perform such analysis on biological samples.

N/A

Intended Use / 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.

Product codes

MOB, MQB

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray

Anatomical Site

human anatomy targeting both adults and children.
General

Indicated Patient Age Range

adults and children

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-Clinical Test summary:

  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: IEC 60601-1, IEC 60601-1-2, IEC 62220-1-1.
  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.
  3. 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. The subject device shows the same DQE as the predicate device (K223930).
  4. Cybersecurity: Complies with "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions"
  5. Label: Complies with 21 CFR 1020.30, 1020.31 and "Pediatric Information for X-ray Imaging Device Premarket Notifications".

Clinical Test Summary:
Clinical data is no provided for this submission.

Key Metrics

DQE: 69% (0.5lp/mm, min.) for IODR1717 and IODR1417, 71% (0.5lp/mm, min.) for IODR1417-GF.
MTF: 97% (0.1lp/mm, min.) for IODR1717 and IODR1417, 98% (0.1lp/mm, min.) for IODR1417-GF.
High Contrast Limiting Resolution (LP/mm): Max. 3.57 for all models.

Predicate Device(s)

K223930

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.

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)

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4

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 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
CodeMQB
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 NameIODR1717IODR1417IODR1417-GF
Sensor Typea-Si TFT
ScintillatorCsI
Total Pixel Number3072 x 3072 pixels2560 x 3072 pixels
Total Pixel Area430 x 430mm358.5 x 430mm
Effective Pixel
Number3036 x 3040 pixels2466 x 3040 pixels
Effective Pixel Area425.04 x 425.6mm345.24 x 425.6mm
Pixel pitch140um

> Detector

7

Limiting ResolutionMax 3.57lp/mm
Energy Range40 ~ 150Kv
A/D Conversion16 bits
Wi-FiIEEE 802.11a/b/g/n/ac, 2.4GHz/5GHz
IP RangeIP54
Communication1Giga-bit Ethernet
Trigger ModeNormal Mode
AED Mode (Auto Exposure Detection Mode)
Packing1 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 DevicePredicate Device#1Note
K NumberK241346K223930-
ManufacturerAspen Imaging Healthcare Inc.H&abyz Co., Ltd.-
Detector NameIODR1717A1717MCW-
Common NameDigital Flat Panel X-ray DetectorDigital Flat Panel X-ray DetectorSame
Product CodeMQBMQBSame
Regulation
Number21 CFR 892.168021 CFR 892.1680Same
510(k) Review
PanelRadiologyRadiologySame
Indications for
UseThe 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
ScintillatorCslCslSame

[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 Pixel

Area425.04 x 425.6 mm425.04 x 425.6 mmSame
Total Pixel
Number3,072 x 3,072 pixels3,072 x 3,072 pixelsSame
Pixel Pitch140um140umSame
High Contrast
Limiting
Resolution
(LP/mm)Max. 3.57Max. 3.57Same
CommunicationWired/WirelessWired/WirelessSame
DQE69% (0.5lp/mm, min.)69% (0.5lp/mm, min.)Same
MTF97% (0.1lp/mm, min.)97% (0.1lp/mm, min.)Same
Anatomical
SitesGeneralGeneralSame
Exposure ModeNormal Mode (Manual),
AED Mode (Auto Exposure
Detection)Normal Mode (Manual),
AED Mode (Auto Exposure
Detection)Same
WirelessIEEE 802.11a/b/g/n/acIEEE 802.11a/b/g/n/acSame

[Table 2. Comparison of Proposed Device(IODR 1417) to Predicate Devices]

Proposed DevicePredicate Device#1Note
K NumberK241346K223930-
ManufacturerAspen Imaging Healthcare Inc.H&abyz Co., Ltd.-
Detector NameIODR1417A1417MCW-
Common NameDigital Flat Panel X-ray DetectorDigital Flat Panel X-ray DetectorSame
Product CodeMQBMQBSame
Regulation
Number21 CFR 892.168021 CFR 892.1680Same
510(k) Review
PanelRadiologyRadiologySame
Indications for
UseThe 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
ScintillatorCslCslSame
Effective Pixel
Area345.24 x 425.6 mm345.24 x 425.6 mmSame
Total Pixel
Number2,560 x 3,072 pixels2,560 x 3,072 pixelsSame

9

Pixel Pitch140um140umSame
High Contrast
Limiting
Resolution
(LP/mm)Max. 3.57Max. 3.57Same
CommunicationWired/WirelessWired/WirelessSame
DQE69% (0.5lp/mm, min.)69% (0.5lp/mm, min.)Same
MTF97% (0.1lp/mm, min.)97% (0.1lp/mm, min.)Same
Anatomical
SitesGeneralGeneralSame
Exposure ModeNormal Mode (Manual),
AED Mode (Auto Exposure
Detection)Normal Mode (Manual),
AED Mode (Auto Exposure
Detection)Same
WirelessIEEE 802.11a/b/g/n/acIEEE 802.11a/b/g/n/acSame

[Table 3. Comparison of Proposed Device (IODR 1417-GF) to Predicate Devices]

Proposed DevicePredicate Device#1Note
K NumberK241346K223930-
ManufacturerAspen Imaging Healthcare Inc.H&abyz Co., Ltd.-
Detector NameIODR1417-GFF1417MCW-
Common NameDigital Flat Panel X-ray DetectorDigital Flat Panel X-ray DetectorSame
Product CodeMQBMQBSame
Regulation
Number21 CFR 892.168021 CFR 892.1680Same
510(k) Review
PanelRadiologyRadiologySame
Indications for
UseThe 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
ScintillatorCslCslSame
Effective Pixel
Area345.24 x 425.6 mm345.24 x 425.6 mmSame
Total Pixel
Number2,560 x 3,072 pixels2,560 x 3,072 pixelsSame
Pixel Pitch140um140umSame
High Contrast
Limiting
Resolution
(LP/mm)Max. 3.57Max. 3.57Same

10

CommunicationWired/WirelessWired/WirelessSame
DQE71% (0.5lp/mm, min.)71% (0.5lp/mm, min.)Same
MTF98% (0.1lp/mm, min.)98% (0.1lp/mm, min.)Same
Anatomical
SitesGeneralGeneralSame
Exposure ModeNormal Mode (Manual),
AED Mode (Auto Exposure
Detection)Normal Mode (Manual),
AED Mode (Auto Exposure
Detection)Same
WirelessIEEE 802.11a/b/g/n/acIEEE 802.11a/b/g/n/acSame

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

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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.