IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR

K092307 · Imasight, Inc. · KPR · Aug 25, 2009 · Radiology

Device Facts

• Record ID: K092307
• Device Name: IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR
• Applicant: Imasight, Inc.
• Product Code: KPR · Radiology
• Decision Date: Aug 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The ImaSight 4600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The ImaSight 4600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. The ImaSight 4600 is not intended for mammography.

Device Story

ImaSight 4600 is a digital radiographic sensor system used to capture X-ray images. It functions as a replacement for traditional radiographic film/screen systems. The device consists of a sensor, an acquisition box, and a computer with display and processing software. It does not include an X-ray source, generator, or tube, which must be provided by independent manufacturers. Operated by qualified doctors or technologists in clinical settings, the sensor collects X-rays from an external source and converts them into digital images. These images are transmitted to the computer for display and processing, allowing clinicians to view diagnostic radiographic exposures. The system benefits patients by providing digital image capture, facilitating efficient diagnostic workflows.

Clinical Evidence

No clinical trials were performed. Substantial equivalence was supported by bench testing (performance, biocompatibility, thermal, electrical, and mechanical safety) and a comparative visual assessment of images against the predicate device.

Technological Characteristics

Digital radiographic sensor utilizing 16-megapixel CCD imaging technology. System includes sensor, acquisition box, and computer workstation. Conforms to ISO 9001 and ISO 13485 quality systems. Operates as a stationary X-ray system component.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of all body parts. Not indicated 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

• Xplorer 1800 Digital Radiographic System (K063247)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "ImaSight GET CLEAR" in a stylized font. The word "ImaSight" is in a larger font size than "GET CLEAR". There is a line above the word "ImaSight". The text is black and the background is white.

AUG 2 5 2009

## 510K SUBMISSION - ABBREVIATED - SUMMARY 2.

- Device type and name: ImaSight 4600 Digital Radiographic Sensor 1.
- 2. Submitter

ImaSight Inc. 10-925 de la Carrière Blvd. Gatineau, Quebec Canada J8Y 6W5

Contact person:

Jean Caseault President Tel: [phone] Fax: [phone] e-mail: ¡[e-mail]

August 11, 2009 Date prepared:

- 3. Device name: ImaSight 4600 Digital Radiography Sensor
- Device classification: Class II, 892.1680 (KPR) র্বা
- 5. Product Code: 90MQB
- e. Basis for the submission: New device
- 7. Predicate device: Xplorer 1800 Digital Radiographic System (K063247)
- The ImaSight 4600 is a digital radiographic sensor which 8. Device description: automatically collects x-ray images from an x-ray source. The ImaSight 4600 sensor collects x-rays and converts them into a computer images for display on a computer. The sensor does not have an x-ray source, which is provided by independent manufacturers. The sensor comes with an acquisition box and a computer, which holds the display and processing software.
- 9. Indications for use: The ImaSight 4600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The Imasight 4600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. The ImaSight 4600 is not intended for mammography.

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FDA Premarket Notification (510k) Submission

22 50 7

Image /page/1/Picture/1 description: The image shows the word "ImaSight" in a stylized font. Below the word "ImaSight" are the words "GET CLEAR" in a smaller, sans-serif font. There is a line above the word "ImaSight".

- 10. Comparison with predicate device: Based on performance tests, the ImaSight 4600 is substantially equivalent to the Xplorer 1800. The ImaSight 4600 produces images of similar quality and performance characteristics that are equivalent to those of the Xplorer 1800. Both systems use the same 16-megapixel CCD imaging sensor technology.
- tests: The sensor has been evaluated for performance, a. Non-clinical biocompatibility, effectiveness, thermal, electrical and mechanical safety and is substantially equivalent to the predicate device. The design, development and production of the sensor conforms to 892.1680, ISO 9001 and ISO 13485 quality systems.
- Clinical tests: A set of images have been submitted along with the equivalent ﺗﻘ images from the predicate device.
- Conclusion: the device was evaluated against the predicate device (Xplorer ﻥ 1800) and was found to be substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

## 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

Imasight, Inc. % Mr. Daniel W. Lehtonen Sr. Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 TWINSBURG OH 44087

## AUG 2 5 2009

Re: K092307

Trade/Device Name: Imasight 4600 Digital Radiography Sensor Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: KPR Dated: July 29, 2009 Received: July 30, 2009

Dear Mr. Lehtonen:

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 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.

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 Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

K092307

Device Name:

Indications For Use:

. ImaSight 4600

The ImaSight 4600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The ImaSight 4600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. The ImaSight 4600 is not intended for mammography.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Ove r-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Loaitha 2thaz
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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