IMIX PANORAD AND SOMARAD

K101435 · Imix Adr Finland OY · KPR · Sep 15, 2010 · Radiology

Device Facts

• Record ID: K101435
• Device Name: IMIX PANORAD AND SOMARAD
• Applicant: Imix Adr Finland OY
• Product Code: KPR · Radiology
• Decision Date: Sep 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

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.

Device Story

IMIX PanoRad and SomaRad are stationary X-ray systems for general-purpose diagnostic imaging. Systems consist of high-frequency X-ray generator (50-65 kW), X-ray tube, collimator, motorized positioning stand, and solid-state CCD digital detector (14"x17" or 17"x17"). Device captures X-ray signals, converting them into digital images via an image acquisition workstation. Operated by clinicians in diagnostic settings; output displayed on software-driven touch panel LCD. DICOM 3 compliance ensures integration into clinical workflows. System replaces traditional film/screen radiography, facilitating faster image acquisition and digital storage. Benefits include improved diagnostic efficiency and workflow integration.

Clinical Evidence

Bench, user, and standards testing performed. Clinical image pairs were evaluated to confirm diagnostic quality. No clinical trials were required; substantial equivalence supported by comparison of technical specifications and performance data against predicate devices.

Technological Characteristics

Stationary X-ray system; 50-65 kW high-frequency generator; CCD digital detector (14"x17" or 17"x17"); 160/139 micron resolution; DICOM 3.0 compliant; software-driven touch panel LCD interface; motorized stand; Ralco R302L/A collimator; UL listed.

Indications for Use

Indicated for generating radiographic images of human anatomy for general-purpose diagnostic procedures. 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

• IMIX Insight (K073114)
• Radstar Digital Imaging System (K083645)
• DICOM Pacs (K070618)

Reference Devices

• IMIX Digital Radiographic Detector (K974863)
• O&R software (K091364)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] E-mail: [e-mail]

## 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.
- 2. 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.
- 3. 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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- 5. 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 Radstar<br>Digital Imaging System<br>made by 5-Star | IMIX PanoRad and<br>SomaRad X-Ray<br>Systems, Combines<br>cleared devices |
|---------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended Use: | General purpose diagnostic<br>X-ray unit | Acquisition of x-ray images<br>when incorporated into an<br>x-ray system, a film<br>substitute. | SAME |
| User Interface | Software Driven Touch<br>Panel LCD | Windows computer | Software Driven Touch<br>Panel 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 For<br>M Co Ltd |
| Image Acquisition | Digital: IMIX Digital<br>Radiographic Detector<br>K974863 | Varian | IMIX or Varian Digital<br>Radiographic Detectors, 9<br>or 16 mp. |
| Digital Panel Size | Active image size: 16 x 16<br>inches (40cm x 40cm) | 17" x 17", 14" x 17", 12" x<br>16" and 8" x 10" panel | 14" x 17" (4336R) OR<br>17" x 17" (4343R) |
| Digital Panel<br>Supplier | IMIX | Varian 4336 and others.<br>(not specified) | Original IMIX panels, same<br>as in K073114 OR:<br>Varian 4343R OR 4336R |
| Digital Resolution | 160 Micron.<br>3056 x 3056 (9 megapixels)<br>or 120 Micron<br>4096 x 4096 (16<br>megapixels) | 7.9 megapixel or 9.4<br>megapixel. 139 micron. | Same as original 510(k), 16<br>megapixels OR<br>7.9 megapixel or 9.4<br>megapixel. 139 micron. |
| DICOM | Yes | Optional | Yes, via O&R software<br>cleared 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 |

- 6. Substantial Equivalence Chart, IMIX PanoRad and SomaRad X-Ray Systems
7. 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 [phone]. 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 [phone] or [phone] 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 |
|---------------------------|---------|
|---------------------------|---------|

KIDI435 SEP 1 5 2010

Device Name: IMIX PanoRad and SomaRad X-Ray Systems

Indications For 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.)

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