Radiology · 510(k) · 2020
FractureDetect (FX)
Imagen Technologies, Inc.. Cleared by FDA on 30 July 2020 under submission K193417, product code QBS (radiological computer assisted detection/diagnosis software for fracture). What FDA's record says, in FDA's words.
Device record · K193417
- Device. FractureDetect (FX)DEVICE
- Company. Imagen Technologies, Inc.COMPANY
- Decision. 30 July 2020, 510(k), substantially equivalent (traditional review); received 9 December 2019DECISION
- Panel. RadiologyPANEL
- Product code. QBS, Radiological Computer Assisted Detection/Diagnosis Software For FractureCODE
- Regulation. 21 CFR 892.2090, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only. FX is indicated for radiographs of the following industry-standard radiographic views and study types. Study Type (Anatomic Area of Interest+) Radiographic View(s) Supported* Ankle Frontal, Lateral, Oblique Clavicle Frontal Elbow Frontal, Lateral Femur Frontal, Lateral Forearm Frontal, Lateral Hip Frontal, Frog Leg Lateral Humerus Frontal, Lateral Knee Frontal, Lateral Pelvis Frontal Shoulder Frontal, Lateral, Axillary Tibia / Fibula Frontal, Lateral Wrist Frontal, Lateral, Oblique *For the purposes of this table, “Frontal” is considered inclusive of both posteroanterior (PA) and anteroposterior (AP) views. +Definitions of anatomic area of interest and radiographic views are consistent with the American College of Radiology (ACR) standards and guidelines.
The product code's definition, from FDA's classification record. A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). The device detects, identifies and/or characterizes fracture based on features or information extracted from images, and may provide information about the presence, location, and/or characteristics of the fracture to the user. Primary diagnostic and patient management decisions are made by the clinical user.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedradiographs (X-ray)
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QBS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QBS, in Radiology, from Imagen Technologies, Inc., or cleared in 2020. The whole record is at FDA AI-enabled medical devices.
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