Fusion Bx

Primary DI
26280558580010
Brand
Fusion Bx
Company
Focal Healthcare Inc
Model
1.1
Device description
Fusion Bx is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians’ existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle guides/templates and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration. The device will assist clinicians in planning and performing image-guided interventional procedures such as biopsies and placing instruments in the prostate for adult men with suspected prostate cancer. Fusion Bx is comprised of a laptop-based workstation and a hardware assembly. The included hardware consists of a frame grabber, encoder converter, hardware arm (comprising of a swing arm, counterbalance, tracker and stepper), and stand. The stepper holds the ultrasound probe and measures probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. Encoders in the stepper and tracker send joint movement information to the computer workstation which tracks probe position and orientation. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of Fusion Bx. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3D image and 3D rendered surface model of the prostate and to display the live image position within the prostate.
Published
2016-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153166000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153166000Fusion BxFocal Healtcare, Inc.2016-01-25LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26280558580010PackageGS11In Commercial Distribution
00628055858003PrimaryGS10
16280558580013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2628055858001026280558580010
00628055858003006280558580036280558580030628055858003
1628055858001316280558580013

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system workstationA freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
200507997
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628055858003Fusion Bx1.12016-10-01
00628055858010Fusion Bx2.02018-08-31
16280558580020Fusion Bx2.02018-08-31

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