Radiological Computer Assisted Detection/Diagnosis Software For Fracture
The Radiological Computer Assisted Detection/Diagnosis Software for Fracture is an image processing device intended to aid in the detection, localization, and characterization of fractures on acquired medical images such as radiography, MRI, or CT, providing information about fracture presence, location, and characteristics to clinicians while primary diagnostic and patient management decisions remain with the clinical user. It is classified as a Class 2 device under regulation 892.2090, requiring 510(k) premarket notification, and falls within the Radiology (RA) medical specialty. The product code is QBS. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QBS
- Device Class
- FDA class 2
- Regulation Number
- 892.2090
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260378 | Rayvolve | May 12, 2026 | Substantially Equivalent | AZmed |
| K242171 | TechCare Trauma | Jan 17, 2025 | Substantially Equivalent | Milvue |
| K240712 | icobrain aria | Nov 07, 2024 | Substantially Equivalent | Icometrix NV |
| K240845 | Rayvolve | Jul 17, 2024 | Substantially Equivalent | Azmed Sas |
| K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | May 25, 2023 | Substantially Equivalent | Ge Medical Systems, LLC |
| K222176 | BoneView | Mar 02, 2023 | Substantially Equivalent | Gleamer |
| K220164 | Rayvolve | Jun 02, 2022 | Substantially Equivalent | Azmed Sas |
| K212365 | BoneView | Mar 01, 2022 | Substantially Equivalent | Gleamer |
| K193417 | FractureDetect (FX) | Jul 30, 2020 | Substantially Equivalent | Imagen Technologies, Inc. |
| DEN180005 | OsteoDetect | May 24, 2018 | Unknown | Imagen Technologies, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.