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510(k) Data Aggregation
K Number
K180414Device Name
EPX-4440FN Digital Video Processor with Light Source
Manufacturer
FUJIFILM New Development U.S.A., Inc.
Date Cleared
2018-05-24
(98 days)
Product Code
FET, GCT, PEA
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
FUJIFILM New Development U.S.A., Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EPX-4440FN Digital Video Processor with Light Source is used for endoscopic or laparoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope or laparoscope (a video camera in an endoscope or laparoscope). This product may be used on all patients requiring endoscopic examination or laparoscopic surgical procedures and when using a FUJIFILM medical endoscope or laparoscope, light source, monitor, recorder and various peripheral devise. FICE (Flexible spectral-Imaging Color Enhancement) is an adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathologic sampling as a means of diagnosis.
Device Description
The EPX-4440FN Digital Video Processor with Light Source is comprised of:
- o VP-4440FN Video Processor with DK-4440E Data Keyboard
- o XL-4450FN Light Source
The EPX-4440FN Digital Video Processor with Light Source consists of the VP-4440FN Video Processor and the XL-4450FN Light Source. The VP-4440FN Video Processor relays the image from a laparoscope or endoscope to a video monitor. The processor also controls the light projected to the body cavity. The XL-4450FN Light Source employs a Xenon lamp with an emergency back-up Halogen lamp. Brightness control is performed by the user.
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K Number
K162836Device Name
FUJIFILM Surgical System
Manufacturer
FUJIFILM New Development U.S.A., Inc.
Date Cleared
2017-03-13
(153 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
FUJIFILM New Development U.S.A., Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FUJIFILM Surgical System includes a laparoscope, video processor and light source and is intended to be used with a monitor, hand instruments, electrosurgical unit, and other ancillary equipment for minimally invasive laparoscopic observation, diagnosis and treatment in general abdominal and gynecologic areas.
Device Description
The FUJIFILM Surgical System is comprised of:
- . EL-580FN Video Laproscope with RC-4440FN Relay Connector
- . EPX-4440FN Digital Video Processor with light source
- o VP-4440FN Video Processor
- o XL-4450FN Light Source
- o DK-4440E Data Keyboard
The EL-580FN Video Laparoscope is comprised of a rigid insertion portion, cable portion. video connector and light guide connector. An optical system, CCD image sensor and electrical circuits are located within the distal end portion of the laparoscope. The video signal lines from the CCD sensor and the light guide fiber bundles are connected to the video connector and light guide connector respectively through the laparoscope and video cables.
The EL-580FN Video Laparoscope is used with the EPX-4440FN Digital Video processor which consists of the VP-4440FN Processor and the XL-4450FN Light Source. The video connector is connected to the video processor via the RC-4440FN Relay Connector and the light connector is connected to the XL-4450FN Light Source. The VP-4440FN Video Processor relays the image from a laparoscope to a video monitor. The processor also controls the light projected to the body cavity. The XL-4450FN Light Source employs a Xenon lamp with an emergency back-up Halogen lamp. Brightness control is performed by the user.
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K Number
K170084Device Name
InterLock Trocar
Manufacturer
FUJIFILM New Development U.S.A., Inc.
Date Cleared
2017-03-10
(59 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
FUJIFILM New Development U.S.A., Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InterLock Trocar has applications in abdominal, thoracic, and gynecological minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
Device Description
The InterLock Trocar is comprised of a minimally invasive surgical trocar (outer sheath sleeve, inner trocar and optical obturator) and accessories (lens cleaning syringe and lens cleaning tube). There are two tubes with a luer lock connector attached to the InterLock Trocar. The tube connected to the Outer sheath sleeve is used for abdominal insufflation and the other attached to the Inner trocar is used for the objective lens cleaning function. The outer diameter of the insertion portion of the outer sheath is approximately 18.5 mm and the overall length of the trocar is approximately 180 mm. The trocar provides two instruments (a 3.8 mm laparoscope and a 5 mm standard, currently marketed hand instrument) with access to the abdominal cavity at the same time. The design of the trocar allows the laparoscope to be in direct alignment with and to follow the hand instrument. This feature provides a surgeon with self-visualization control, meaning that the camera is in direct alignment or parallel to the hand instrument. Therefore, the hand instrument is always in the field of view of the laparoscope. The laparoscope does not need to be held by a surgeon. The trocar holds the laparoscope and no additional surgeon or assistant is required to control operation of the laparoscope. The trocar also provides features for insufflating the peritoneal cavity and cleaning the 3.8 mm laparoscope lens without removing it from the trocar. The InterLock Trocar is for exclusive use with a 3.8 mm laparoscope.
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