FUSION FLAT PANEL

K113449 · Icrco, Inc. · MQB · Jun 14, 2012 · Radiology

Device Facts

• Record ID: K113449
• Device Name: FUSION FLAT PANEL
• Applicant: Icrco, Inc.
• Product Code: MQB · Radiology
• Decision Date: Jun 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The iCRco Fusion Flat Panel DR System is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding, fluoroscopy, angiography and mammography. Fusion Flat Panel DR allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

Device Story

Fusion Flat Panel DR System is a digital radiography detector; captures X-ray signals to produce digital images for diagnostic use. Used in clinical settings by healthcare professionals; replaces conventional screen-film systems. Device facilitates imaging of skull, chest, shoulders, spine, abdomen, and extremities. Output is digital radiographic image displayed for physician review; aids in clinical diagnosis of anatomical structures. Benefits include transition from analog to digital workflow; improved image management; reduced radiation exposure potential compared to film.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Digital radiography detector; flat panel sensor technology. System is designed for general radiographic imaging. Connectivity via standard digital interfaces for image transmission. Software-based image processing for acquisition and display. Sterilization not applicable as device is not invasive.

Indications for Use

Indicated for general radiographic examinations of the skull, chest, shoulders, spine, abdomen, and extremities in patients where conventional screen-film systems are used. Excludes fluoroscopy, angiography, and 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

• iCRco, Inc. iCRco Digital Radiography System (K103566)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

# 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

Mr. Greg Wachtler Manager, Regulatory Compliance iCRco. Inc. 2580 West 237th Street TORRANCE CA 90505

JUN 1 4 2012

Re: K113449

Trade/Device Name: Fusion Flat Panel Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MOB Dated: May 25, 2012 Received: May 31, 2012

#### Dear Mr. Wachtler:

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,

Janine M. Morris

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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# Indications for Use

510(k) Number (if known): K113449

Device Name: Fusion Flat Panel

Indications For Use: The iCRco Fusion Flat Panel DR System is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding, fluoroscopy, angiography and mammography. Fusion Flat Panel DR allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

Prescription Use: YES

### ANDIOR

# Over-the-Counter Use: NO

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices stic Device Eva uation and Sa Office of In 510K

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