IMIX PanoRad and SomaRad X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (Not for mammography.)

Device Description

The PanoRad consists of: A high resolution CCD detector with 14" x 17" or 17" x 17" image area. An X-Ray Tube & Collimator. A fully motorized positioned. A 65 kW high frequency generator. A 4 way floating table. An Image Acquisition workstation with DICOM 3 compliance.

The SomaRad consists of: A high resolution CCD detector with 14" x 17" or 17" x 17" image area. An X-Ray Tube & Collimator. A fully motorized positioned. A 50 kW high frequency generator. A table. An Image Acquisition workstation with DICOM 3 compliance.

AI/ML Overview

The provided text describes a 510(k) summary for the IMIX PanoRad and SomaRad X-Ray Systems (K101435). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study.

Therefore, many of the requested elements for a study proving acceptance criteria (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how training set ground truth was established, and specific quantifiable acceptance criteria) are not applicable in this context. The document's purpose is to show that the new device is as safe and effective as previously cleared devices by comparing technical specifications and intended use.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this 510(k) is primarily based on substantial equivalence to predicate devices. The device "meets acceptance criteria" if it is determined to be as safe and effective as the predicate devices, with no new indications for use or significant technological differences that would raise new questions of safety or effectiveness.

Characteristic	Acceptance Criteria (Based on Predicate Devices)	Reported Device Performance (IMIX PanoRad and SomaRad X-Ray Systems)
Intended Use	General purpose diagnostic X-ray unit. Acquisition of x-ray images when incorporated into an x-ray system, a film substitute.	SAME (General purpose diagnostic X-ray unit. Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. Not for mammography.)
User Interface	Software Driven Touch Panel LCD or Windows computer	Software Driven Touch Panel LCD
Generator	Stadler or equivalent	CPI or Stadler (Ranges from 50 and 65 kW)
Maximum Output	40, 50, and 65 kW or equivalent	50 and 65 kW
Stand	Supplied by Sedecal or equivalent	Supplied by Shinyoung For M Co Ltd
Image Acquisition	Digital: IMIX Digital Radiographic Detector K974863, Varian detectors, 9 or 16 mp.	IMIX or Varian Digital Radiographic Detectors, 9 or 16 mp.
Digital Panel Size	Active image size: 16 x 16 inches (40cm x 40cm), 17" x 17", 14" x 17", 12" x 16" and 8" x 10" panel	14" x 17" (4336R) OR 17" x 17" (4343R)
Digital Panel Supplier	IMIX, Varian 4336 and others	Original IMIX panels (same as K073114) OR: Varian 4343R OR 4336R
Digital Resolution	160 Micron. 3056 x 3056 (9 megapixels) or 120 Micron. 4096 x 4096 (16 megapixels). 7.9 megapixel or 9.4 megapixel. 139 micron.	Same as original 510(k), 16 megapixels OR 7.9 megapixel or 9.4 megapixel. 139 micron.
DICOM	Yes or Optional	Yes, via O&R software cleared in K091364
Method of Control	Touch Panel LCD or Windows computer	Touch Panel LCD
Collimator	Ralco R302L/A DHHS or equivalent	Ralco R302L/A DHHS
Safety	UL listed	UL listed

Study Information (Based on the provided text)

Sample size used for the test set and the data provenance:
- The document mentions "user (clinical image pairs)" as part of the testing data. However, it does not specify the sample size (number of images or patients) used for this "user" testing.
- The data provenance (country of origin, retrospective/prospective) is not explicitly stated.
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 "user (clinical image pairs)" testing implies some form of review, but the details of who performed this review, their number, or qualifications are absent. Given it's a 510(k) for an X-ray system rather than an AI diagnostic device, formal ground truth establishment by multiple experts is less common.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided.
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 MRMC study was done or mentioned. This document is for an X-ray imaging system, not an AI-assisted diagnostic tool. Its purpose is to demonstrate the safety and effectiveness of the hardware and software for image acquisition, primarily through comparison with predicate devices' technical specifications.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an X-ray system, not a standalone algorithm for diagnosis. The "standalone" performance here refers to the system's ability to produce diagnostic quality images, which is addressed by a combination of bench testing, user testing, and adherence to standards.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The term "ground truth" in the context of an X-ray system's performance is typically less about definitive diagnostic labels (like pathology) and more about the diagnostic quality of the images produced and their ability to aid in general diagnostic procedures. The "user (clinical image pairs)" testing likely involved qualitative assessment of image quality for diagnostic purposes, relative to the predicate devices. However, the specific type of ground truth (e.g., clinical interpretation, comparison to established standards for image quality) is not detailed.
The sample size for the training set:
- Not applicable. This is not an AI algorithm trained on a dataset in the way a diagnostic AI would be. The device's software is "identical to K070618" (a DICOM Pacs device), indicating it's a pre-existing software component rather than one developed through machine learning.
How the ground truth for the training set was established:
- Not applicable for the same reasons as above.

Summary of the Study and Conclusion:

The "study" or evaluation performed for the IMIX PanoRad and SomaRad X-Ray Systems was a substantial equivalence comparison. This involved:

Bench testing: Evaluating the technical specifications and performance of the components.
User testing (clinical image pairs): Likely qualitative assessment of image quality in a clinical setting by users. The details of this testing (sample size, expert involvement, ground truth, adjudication) are not provided.
Standards testing: Ensuring compliance with relevant industry and safety standards (e.g., UL listed).

The conclusion was that the device is "as safe and effective as the predicate devices, have few technological differences, and have no new indications for use," thereby establishing substantial equivalence. This is a regulatory pathway, not a clinical trial designed to quantify performance against a specific clinical acceptance criterion.

Summary

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Image /page/0/Picture/0 description: The image shows the text "510(k) Summary K10j" at the top. Below this text is a graphic of a wave pattern with two black dots above it. Underneath the wave pattern is the text "IMIX Immediate Method of Imaging X-rays".

K101435

SEP 1 5 2010

IMIX ADR Finland OY Peltokatu 16 D3 33100 Tampere Finland Telephone: +358 (3) 2129 850 Fax: +358 (3) 2129 852 E-mail: emea@imixadr.com

Contact: Sigrid Smitt-Jeppesen President and CEO IMIX Americas Date Prepared: May 13, 2010

1. Identification of the Device: Proprietary-Trade Name: IMIX PanoRad and SomaRad X-Ray Systems Classification Name: Stationary X-ray system, Product Codes Product Codes KPR, MOB, and LLZ Common/Usual Name: General purpose diagnostic X-ray Unit.
1. Equivalent legally marketed devices: K073114, IMIX Insight; K083645 Radstar Digital Imaging System made by 5-Star, and K070618, DICOM Pacs made by O&R. The IMIX PanoRad and SomaRad X-Ray Systems use the identical panel to K083645 and the identical software to K070618.
1. Indications for Use (intended use) IMIX PanoRad and SomaRad X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. Not for mammography.

4. Description of the Device:

The PanoRad consists of:
- A high resolution CCD detector with 14" x 17" or 17" x 17" image area. t
- An X-Ray Tube & Collimator. .
- A fully motorized positioned .
- A 65 kW high frequency generator .
- A 4 way floating table .
- An Image Acquisition workstation with DICOM 3 compliance.

The SomaRad consists of:

A high resolution CCD detector with 14" x 17" or 17" x 17" image area. .
An X-Ray Tube & Collimator. .
A fully motorized positioned .
A 50 kW high frequency generator .
A table .
An Image Acquisition workstation with DICOM 3 compliance.

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1. Safety and Effectiveness, comparison to predicate device. The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices. The changed components are in fact identical to the predicate devices.

Characteristic	K073114, IMIX Insight	K083645 RadstarDigital Imaging Systemmade by 5-Star	IMIX PanoRad andSomaRad X-RaySystems, Combinescleared devices
Intended Use:	General purpose diagnosticX-ray unit	Acquisition of x-ray imageswhen incorporated into anx-ray system, a filmsubstitute.	SAME
User Interface	Software Driven TouchPanel LCD	Windows computer	Software Driven TouchPanel LCD
Generator	Stadler	Not supplied	CPI or Stadler
Maximum output	40, 50, and 65 kW	Not supplied	50 and 65 kW
Stand	Supplied by Sedecal	Not supplied	Supplied by Shinyoung ForM Co Ltd
Image Acquisition	Digital: IMIX DigitalRadiographic DetectorK974863	Varian	IMIX or Varian DigitalRadiographic Detectors, 9or 16 mp.
Digital Panel Size	Active image size: 16 x 16inches (40cm x 40cm)	17" x 17", 14" x 17", 12" x16" and 8" x 10" panel	14" x 17" (4336R) OR17" x 17" (4343R)
Digital PanelSupplier	IMIX	Varian 4336 and others.(not specified)	Original IMIX panels, sameas in K073114 OR:Varian 4343R OR 4336R
Digital Resolution	160 Micron.3056 x 3056 (9 megapixels)or 120 Micron4096 x 4096 (16megapixels)	7.9 megapixel or 9.4megapixel. 139 micron.	Same as original 510(k), 16megapixels OR7.9 megapixel or 9.4megapixel. 139 micron.
DICOM	Yes	Optional	Yes, via O&R softwarecleared in K091364
Method of Control	Touch Panel LCD	Windows computer	Touch Panel LCD
Collimator	Ralco R302L/A DHHS	Not supplied	Ralco R302L/A DHHS
Safety	UL listed	UL listed	UL listed

1. Substantial Equivalence Chart, IMIX PanoRad and SomaRad X-Ray Systems

Conclusion: After analyzing bench, user (clinical image pairs), and standards testing data, it is the conclusion of IMIX ADR that the IMIX PanoRad and SomaRad X-Ray Systems are as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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

IMIX ADR Finland OY % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

SEP 1 5 2010

Re: K101435

Trade/Device Name: IMIX PanoRad and SomaRad X-Ray Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: July 32, 2010 Received: July 29, 2010

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 510(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.

Donald J. Trump

Donald J. St.Pierre Acting 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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510(k) Number (if known):	K101435
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KIDI435 SEP 1 5 2010

Device Name: IMIX PanoRad and SomaRad X-Ray Systems

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)

Page 1 of 1

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K101435

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.