(206 days)
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Not Found
No
The provided 510(k) summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No.
The device is described as an imaging system for diagnostic purposes, not for treating conditions.
No
Explanation: The device is used for imaging (general radiographic examinations) and does not describe any diagnostic capabilities beyond image acquisition. It captures images of anatomical sites but does not indicate that it analyzes those images to determine the nature or cause of a disease or condition.
No
The device description explicitly states "Flat Panel DR System," indicating a hardware component (the flat panel detector) is integral to the device's function.
Based on the provided information, the iCRco Fusion Flat Panel DR System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "general radiographic examinations" and "imaging of the skull, chest, shoulders, spine, abdomen, and extremities." This describes a device used for in vivo imaging (imaging within a living organism).
- IVD Definition: In vitro diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro) to provide information about a person's health.
The iCRco Fusion Flat Panel DR System is a medical imaging device used to capture images of the internal structures of the body directly, not by analyzing samples taken from the body.
N/A
Intended Use / 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.
Product codes
MOB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
skull, chest, shoulders, spine, abdomen, and extremities.
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.
0
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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
2
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
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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