IDR

K082450 · Icrco, Inc. · MQB · Jun 30, 2009 · Radiology

Device Facts

• Record ID: K082450
• Device Name: IDR
• Applicant: Icrco, Inc.
• Product Code: MQB · Radiology
• Decision Date: Jun 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The iDR is indicated for use in generating diagnostic medical x-rays images of human anatomy. It is intended to replace radiographic film/ screen systems in all general - purpose diagnostic radiographic procedures. It is not intended for mammography applications.

Device Story

iDR is a stationary x-ray system designed to replace traditional radiographic film/screen systems. It captures x-ray signals to generate diagnostic images of human anatomy. Used in clinical settings by healthcare professionals for general-purpose radiographic procedures. Output is a digital diagnostic image used by clinicians to inform medical decision-making and patient diagnosis. Device excludes mammography applications.

Clinical Evidence

Bench testing only.

Technological Characteristics

Stationary x-ray system (21 CFR 892.1680); digital radiography; replaces film/screen systems; general-purpose diagnostic imaging.

Indications for Use

Indicated for generating diagnostic medical x-ray images of human anatomy in general-purpose radiographic 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.

Submission Summary (Full Text)

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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. Thomas Chaney QA/QC Manager iCRco, Inc. 2580 West 237th Street TORRANCE CA 90505

AUG 2 3 2013

Re: K082450 Trade/Device Name: iDR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: June 11, 2009 Received: June 16, 2009

Dear Mr. Chaney:

This letter corrects our substantially equivalent letter of June 30, 2009.

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): K082450

Device Name: iDR

Indications For Use:

The iDR is indicated for use in generating diagnostic medical x-rays images of human anatomy. It is intended to replace radiographic film/ screen systems in all general - purpose diagnostic radiographic procedures.

It is not intended for mammography applications.

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 Device Evaluation (ODE)

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Division of Reproductive, Abdominal,

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Division of Reproductive, Abdominal, Division of Radiological Dev 510(k). Number

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