Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

Device Description

The innovaXion FP represents a modification of our own predicate K071402 X3C 1600 plus Digital Radiographic System. We now support the 510(k) cleared Samsung digital panel. The other radiographic equipment is identical to that supplied by Viztek in Ku 102123. We will market the product in four possible configurations:
. innovaXion FP 1600 Plus
innovaXion FP (flat panel as a retrofit package with Magellan FP software) .
. Magellan (software)

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated)	Reported Device Performance
Substantial Equivalence to Predicate Devices	"The results of clinical, bench, safety test, and software validation testing indicates that the new device is as safe and effective as our predicate device." "After analyzing risk analysis, software validation, safety testing data, and clinical images, it is the conclusion of IDC that the innovaXion FP software is as safe and, suite onlined predicate devices, have almost no technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate devices."
Safety and Effectiveness comparable to predicate devices	"This modified device has the same indications for use and technological characteristics as the predicate devices, in fact supplying the predicate devices in the end product. The only difference is adding a new panel (cleared sparely) ) and requisite software."
Conformance to US Performance Standards	"The modified device conforms to US Performance Standards and the hardware is CSA Listed to US Standards for softon for medical devices."
UL listed to US Standards for safety (for digital receptor panels)	"The digital receptor panels are UL listed to US Standards for safety for medical devices."

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

Sample Size: Not explicitly stated. The document mentions "Clinical images were acquired" but does not give a specific number.
Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective in comparison, as "clinical images were acquired and compared to our predicate images," suggesting existing data from the predicate device was used for comparison.

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

This information is not provided in the document. The abstract does not detail the process of establishing ground truth for the clinical images used in the comparison.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

No, a multi-reader, multi-case comparative effectiveness study of the device with human readers was not done or described. The study focuses on comparing the new device's images to the predicate device's images.
This device is a digital X-ray system, not an AI-assisted diagnostic tool, so the concept of human readers improving with AI assistance is not applicable in this context.

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

The study described is a standalone performance comparison of the device itself (new digital panel and software) against a predicate device, based on acquired clinical images. It assesses image quality and output, not an algorithm's diagnostic performance. Therefore, in a sense, it's a "standalone" evaluation of the imaging system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document implies that the ground truth for the clinical images was established by the predicate images themselves serving as the reference. The new device's images were compared to these predicate images to determine if there were "no significant differences between them," implying the predicate images represented an acceptable standard. There's no mention of expert consensus, pathology, or outcomes data being used to establish a separate, independent ground truth.

8. The sample size for the training set

This information is not applicable as the device is not an AI algorithm that requires a training set in the typical sense. It's a digital X-ray system.

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

This information is not applicable for the same reason as point 8.

Summary

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510(K) Summary, Special 510(k) K11 Page 1 of 2 Submitter: Imaging Dynamics Company, Ltd. 151, 2340 Pegasus Way N.E. Calgary, Alberta, Canada T2E 8M5 MAY 2 7 2011 Tel: 403.251.9939 Fax: 403.251.1771 www.imagingdynamics.com Date prepared: March 25, 2011 Contact person: Nichole Wheery

K111098

Quality Assurance and Regulatory Affairs Manager

Identification of the Device: 1.

Proprietary-Trade Name: innovaXion FP (various models) Classification Name: System, x-ray, stationary, KPR and solid state x-ray imager (flat panel/digital imager), MQB Common/Usual Name: Stationary Diagnostic X-ray System with Digital Panel

Common/Usual Name: Stationary Diagnostic X-ray System with Digital Panel

Equivalent legally marketed devices: 2.

K071402 X3C 1600 plus Digital Radiographic System, IDC (Imaging Dynamics Company) .
K102123, Vizion DR, Viztek .
K090742, LTX240AA01-A, Samsung .
Description of the Device: The innovaXion FP represents a modification of our own predicate 3. K071402 X3C 1600 plus Digital Radiographic System. We now support the 510(k) cleared Samsung digital panel. The other radiographic equipment is identical to that supplied by Viztek in Ku 102123. We will market the product in four possible configurations:
- . innovaXion FP 1600 Plus
- innovaXion FP (flat panel as a retrofit package with Magellan FP software) .
- . Magellan (software)
1. Indications for Use (intended use): Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, pointal column, chest, abdomen, extremities, and other body parts on both and pediation with Applications can be performed with patient sitting, standing on the promethy pations.
  Not in the contribution sitting, standing on lying in the prone or supine positions. Not intended for mammography.
1. Safety and Effectiveness, comparison to predicate device. This modified device has the same indications for use and technological characteristics as the predicate devices, in fact supplying the predicate devices in the end product. The only difference is adding a new panel (cleared sparely) ) and requisite software. This device is identical to the Viztek predicate except for the DVCOM software.
Description of Testing: Clinical images were acquired and compared to our predicate images. 6. There were no significant differences between them. We also performed software validating, and The results of clinical, bench, safety test, and software validation testing indicates that the new device is as safe and effective as our predicate device. The modified device conforms to US Performance Standards and the hardware is CSA Listed to US Standards for softon for medical devices. The digital receptor panels are UL listed to US Standards for safety for medical devices.

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Page 2 of 2

1. Conclusion: After analyzing risk analysis, software validation, safety testing data, and clinical images, it is the conclusion of IDC that the innovaXion FP software is as safe and, suite onlined predicate devices, have almost no technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Imaging Dynamics Co., Ltd. % Mr. Daniel Kamm Principal Consultant Kamm & Associates 8870 Ravello Ct MAPLES FL 34114

MAY 2 7 2011

Re: K111098

Trade/Device Name: innovaXion FP (various models) Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II Product Code: MOB Dated: April 12, 2011 Received: April 20, 2011

Dear Mr. Kamm:

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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5.10(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K11 | 09

innovaXion FP (various models) Device Name:

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patel
(Division Sign Off)

Division of Radiolog Office of In Vitro 510K

Page 1 of 1

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.