ICRCO 3600M

K122510 · Icrco, Inc. · MUE · Apr 26, 2013 · Radiology

Device Facts

• Record ID: K122510
• Device Name: ICRCO 3600M
• Applicant: Icrco, Inc.
• Product Code: MUE · Radiology
• Decision Date: Apr 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1715
• Device Class: Class 2

Intended Use

The iCR3600M CR Mammography Feature together with iCR3600M CR Mammography Cassette comprise a device which, when used in conjunction with an iCRco 3600 CR System and a mammographic x-ray machine, generates digital mammographic images. The device is intended to be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by an MQSA qualified physician using either hardcopy film or softcopy display at a workstation.

Device Story

The iCR3600M is a computed radiography (CR) system component designed for digital mammography. It consists of a specialized mammography feature and cassette used with an iCRco 3600 CR system and a standard mammographic x-ray machine. The device captures x-ray signals to generate digital mammographic images. These images are processed and then interpreted by an MQSA-qualified physician via hardcopy film or softcopy workstation display. The system is used in clinical settings for breast cancer screening and diagnosis, providing an alternative to traditional screen-film mammography. It assists clinicians in visualizing breast tissue to aid in the detection and diagnosis of breast cancer.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and technological comparison to existing mammography systems.

Technological Characteristics

Computed Radiography (CR) system for mammography. Includes specialized mammography cassette and CR system integration. Operates with mammographic x-ray machines. Digital image output for softcopy or hardcopy interpretation. Complies with 21 CFR 892.1715.

Indications for Use

Indicated for screening and diagnosis of breast cancer in patients requiring mammographic imaging. Intended for use in clinical applications equivalent to traditional screen-film mammography systems.

Regulatory Classification

Identification

A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”*See* § 892.1(e) for the availability of this guidance document.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

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

April 26, 2013

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

Re: K122510

Trade/Device Name: iCRco 3600M Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: April 19, 2013 Received: April 24, 2013

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Wachtler

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/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jamila M. Mense

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K122510

Device Name: iCR 3600M

Indications for Use:

The iCR3600M CR Mammography Feature together with iCR3600M CR Mammography Cassette comprise a device which, when used in conjunction with an iCRco 3600 CR System and a mammographic x-ray machine, generates digital mammographic images. The device is intended to be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by an MQSA qualified physician using either hardcopy film or softcopy display at a workstation.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K122510 510(k)

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