CLIO/CLIOSOFT

K110886 · Sota Precision Optics, Inc. · LLZ · Jun 30, 2011 · Radiology

Device Facts

• Record ID: K110886
• Device Name: CLIO/CLIOSOFT
• Applicant: Sota Precision Optics, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jun 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

CLIOSOFT is a clinical software application that receives images and data from CLIO sensor and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, CLIOSOFT enables the storage of clinical notes and clinical exam data. It is intended to acquire, display, process, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images using standard PC hardware.

Device Story

CLIO/CLIOSOFT is a dental diagnostic imaging system comprising an intraoral CMOS X-ray sensor and software. The sensor captures X-ray images, transmitting them via USB to a standard PC. The software (CLIOSOFT) manages image acquisition from the sensor, intraoral cameras, flatbed scanners, and other radiographic devices. It provides tools for viewing, processing (contrast adjustment, resizing, annotation), storing, and distributing images and clinical notes. Used in dental clinics by dentists and staff; the system facilitates patient record management and diagnostic review. By digitizing and organizing dental images, the device assists clinicians in diagnostic decision-making and patient treatment planning.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1) and electromagnetic compatibility (EN 60601-1-2) testing, alongside software validation.

Technological Characteristics

System includes CMOS intraoral X-ray sensors (Size 1 and 2) and software. Connectivity via USB 2.0. Dynamic range 4096:1. Operates on standard PC hardware (Windows XP/Vista/7). Software performs image acquisition, processing, and database management. Complies with IEC 60601-1 and EN 60601-1-2 standards.

Indications for Use

Indicated for use by dental professionals to acquire, display, process, edit, review, store, print, and distribute dental radiographic and clinical images and data. No specific patient population or contraindications described.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• VixWin Pro (K060178)
• Digital X-ray Sensor (K092537)

Submission Summary (Full Text)

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K110886

. JUN 3 0 2011

# 510(k) Summary

As Required by 21 CFR Section 807.92 (c)

## 1. Submitter Information

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| Name: | SOTA Imaging |
|-------------------|-----------------------------------------------------------|
| Address: | 1073 North Batavia Street Suite B<br>Orange, CA 92867 USA |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | Brian Kim, President |
| Date Prepared: | March 23, 2011 |

## 2. Identification of the Device

| Trade Name: | CLIO/CLIOSOFT |
|----------------------|--------------------------------------------------------------------------------------------|
| Common/Usual Name: | Dental Image Management System |
| Classification Name: | Picture Archiving and Communications System or<br>System, X-ray, Extraroal Source, Digital |
| Product Code: | LLZ or MUH |
| Regulation: | 21 CFR 892.2050 or 21 CFR 892.1800, Class II |

### 3. Equivalent legally Marketed Device

| Manufacturer: | GENDEX DENTAL SYSTEMS |
|----------------|-----------------------------------------------|
| Product Name: | VixWin Pro |
| Product Code: | MUH and LLZ |
| Regulation: | 21 CFR 892.1800 and 21 CFR 892.2050, Class II |
| 510(k) Number: | K060178 |
| Manufacturer: | TOSHIBA AMERICA ELECTRONIC COMPONENTS, INC. |
| Product Name: | Digital X-ray Sensor |
| Product Code: | MUH |
| Regulation: | 21 CFR 892.1800, Class II |
| 510(k) Number: | K092537 |

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#### 4. Device Description

CLIO/CLIOSOFT is a system for general dental diagnostic imaging. CLIO is an intraoral x-ray sensor and CLIOSOFT is a software program. CLIO has size 1 and size 2 sensors. CLIO sensor connects to the PCcompatible computer via an USB port. CLIOSOFT controls capture, display, treatment, review, store, print, and distribute digital x-ray images from CLIO sensors. It can also handle other types of images acquired by digitizing film with a flatbed scanner, or color images from an intraoral dental camera such as the Claris i310 series. CLIO/CLIOSOFT runs on standard PC-compatible computers.

CLIO connects to the computer via USB port.

When properly installed in your computer, CLIOSOFT lets you:

- . Control the direct capture of digital x-ray images from the intraoral sensor CLIO.
- . View and capture live image from intraoral cameras via USB 2.0 or video capture card.
- . Import images from various sources such as radiographic devices, flatbed scanner, digital camera, and generic image devices.
- . Export, e-mail, and print images.
- . Process digital images with several tools to enhance their diagnostic value.
- . Create a database of patients and store images in patient folders.

#### 5. Indications for Use

CLIOSOFT is indicated for use as a clinical software application that receives images and data from CLIO sensor and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, CLIOSOFT enables the storage of clinical notes and clinical exam data.

lt is intended to acquire, display, process, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images using standard PC hardware.

#### 6. Safety and Effectiveness, Comparison to Predicate Device

CLIO/CLIOSOFT is safe and effective as the predicate device cited above.

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#### 6.1 Substantial Equivalence Chart

| Description | VixWin Pro<br>(K060178) | Toshiba Digital X-ray Sensor<br>(K092537) | CLIO/CLIOSOFT |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Controls capture, display, treatment, analysis and saving of X-ray digital images from DenOptix®, Visualix®/GX-S, Orthoralix 9200 DPI and DDE digital imaging systems produced by Gendex. It can also handle other types of digital images, e.g. color images from an intraoral or extraoral dental camera, such as the Gendex Concept IV series, or images acquired by digitizing film with a flat bed scanner. | Toshiba Digital X-ray Sensor is an intraoral receiver of X-ray energy by the dentist to obtain instant images of teeth and the oral cavity of patients. Images are transmitted to a computer for display. | CLIOSOFT is indicated for use as a clinical software application that receives images and data from CLIO sensor and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, CLIOSOFT enables the storage of clinical notes and clinical exam data. It is intended to acquire, display, process, edit (e.g., resize, adjust contrast, annotate, etc), review, store, print, and distribute images using standard PC hardware. |
| Implementation | Software only | Sensor only | Sensor and/or Software |
| Number of sensors | - | 4<br>two for size 1 and<br>two for size 2 | 2<br>Size 1 and size 2 |
| Sensor size (mm) | - | Size 1: 40.1 x 25.1<br>Size 2 soft: 44.4 x 32.6<br>Size 2 hard: 43.7 x 31.9 | Size 1: 36.73 x 24.35<br>Size 2: 42.80 x 30.49 |
| Technology | - | CMOS | CMOS |
| Interface to PC | - | USB | USB |
| Dynamic Range | - | 4096:1 | 4096:1 |
| Sensor cable length (m) | - | 2.5 | 3 |
| Host platform | PC | - | PC |
| Operating system | Windows 98, 2000, XP | - | Windows XP, Vista, 7 (32/64 bit) |
| Host RAM | 32 MB | - | 512 MB |
| Host Magnetic Storage | 4 GB, 9 GB or higher recommended | - | 80 GB, 250 GB or higher recommended |
| CD-ROM | Yes | - | Yes |
| Host Processor | Intel Pentium 133 MHz, 200 MHz or higher recommended | - | Intel Pentium 4 2.0 GHz or higher |
| Host Monitor Size | SVGA, XGA recommended | - | XGA, SXGA recommended |
| Display Resolution | 800x600, 1024x768 recommended | - | 1024x768, 1280x1024 recommended |

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#### 6.2 Meaningful Differences

The sensor included in the CLIO/CLIOSOFT system is provided as OEM and the specification and configuration is similar to TOSHIBA Digital X-ray Sensor (K092537) that already approved. The sensor is safe and effective based on the following references:

- CB TEST CERTIFICATE for IEC 60601-1:1988 +A1:1991 +A2:1995 and CB TEST CERTIFICATE for IEC 60601-1:2005 (except 60601-1-6) see Appendix C
- SAFETY TEST ACCORDING TO THE STANDARD IEC 60601-1:1988 +A1:1991 +A2:1995 see Appendix D
- SAFETY TEST ACCORDING TO THE STANDARD IEC 60601-1:2005 (without 60601-1-6) see Appendix E
- EMC TEST ACCORDING TO THE STANDARD EN 60601-1-2:2007 ' see Annex Document No. 4 in Appendix D
- EMC TEST ACCORDING TO THE STANDARD EN 60601-1-2:2007 see Attachment No. 9 in Appendix E
- Software Validation see Exhibit 14
- Reference 510(k) sensor: K092537

### 7. Conclusion

CLIO/CLIOSOFT is substantially equivalent to legally marketed Image Processing Systems (i.e. PACS).

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Public Health Service

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

Mr. Bram Kim President SOTA Precision Optics, Inc. DBA SOTA Imaging 1073 North Batavia Street Suite B ORANGE CA 92867

JUN 3 0 201

Re: K110886

Trade/Device Name: CLIO/CLIOSOFT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 9. 2011 Received: June 14, 2011

Dear Mr. 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 (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 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,

Mary Patel

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 Form

510(k) Number (if known): Kli 0880

Device Name: CLIO/CLIOSOFT

Indications for Use:

CLIOSOFT is a clinical software application that receives images and data from CLIO sensor and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, CLIOSOFT enables the storage of clinical notes and clinical exam data.

It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute images using standard PC hardware.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Subpart D) (21 CFR 801 Subpart C)

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

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

Mairy S. Padell

Division Sigh-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K 110886

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