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510(k) Data Aggregation
K Number
K993673Device Name
SNN FLUORO NAVIGATION SYSTEM
Manufacturer
I.S.G. TECHNOLOGIES, INC.
Date Cleared
1999-12-21
(50 days)
Product Code
HAW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
I.S.G. TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SNN System is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine. The SNN System is contraindicated for patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured.
The SNN Fluoro Navigation Module is also indicated for situations where reference to a rigid anatomical structure such as the skull, a long bone or vertebra can be identified relative to a fluoroscopic image of the anatomy.
Device Description
The SNN Fluoro Navigation System is a module of the SNN System to provide image-guided surgery based on an intra-operative fluoroscopic image of the patient anatomy.
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K Number
K982570Device Name
SNN SCOUT
Manufacturer
I.S.G. TECHNOLOGIES, INC.
Date Cleared
1999-01-13
(174 days)
Product Code
HAW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
I.S.G. TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SNN Scout is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine. The SNN Scout is contraindicated for patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured.
Device Description
The passive sensor feature is an addition to the SNN Scout image-guided surgical system. This feature is designed to improve the ergonomics of the user/device interaction by eliminating the cable connections between the tracked surgical instruments and the computer workstation.
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K Number
K980684Device Name
VR NETSERVE
Manufacturer
I.S.G. TECHNOLOGIES, INC.
Date Cleared
1998-05-06
(72 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
I.S.G. TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VR SOFTSTORE is a software device intended to direct the lossless archival storage and retrieval, including the use of pre-fetching and auto-routing capabilities, of digital medical images within a Picture Archiving and Communications System (PACS).
VR SOFTSTORE may be used for the permanent storage and subsequent retrieval of any medical imaging data presented in DICOM or other supported format, within a Picture Archiving and Communications System (PACS).
Device Description
The VR NetServe software module is an addition to the VR SOFTSTORE medical image archive system which allows the user to access patient images using web server technology to query the database and display retrieved images. The intended use of the VR SOFTSTORE system containing this module has not been modified by this addition.
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K Number
K973413Device Name
ID. STORE (RELEASE 2.0)
Manufacturer
I.S.G. TECHNOLOGIES, INC.
Date Cleared
1997-11-25
(77 days)
Product Code
LMB
Regulation Number
892.2010Why did this record match?
Applicant Name (Manufacturer) :
I.S.G. TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ID.Store is a software device intended to direct the lossless archival storage and retrieval, including the use of pre-fetching and auto-routing capabilities, of digital medical images within a Picture Archiving and Communications System (PACS).
ID.Store may be used for the permanent storage and subsequent retrieval of any medical imaging data presented in DICOM or other supported format, within a Picture Archiving and Communications System (PACS).
Device Description
The ID.Store device is a software package composed of several application modules which work in tandem using a distributed storage architecture to control the archival storage and retrieval of digitized medical images. The ID.gate (gateway), ID.store (archiving), and ID.dbs (image database manager) modules communicate with each other using the dedicated administrative communication protocol ImageTalk. Permanent archival storage media supported include CD-R, WORM, MOD/WORM, DVD, etc. Recommended hardware are standard general purpose equipment, e.g. Sun Sparc or UltraSparc CPU's, and RAID devices for temporary data storage.
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K Number
K970865Device Name
ISG FAMILY OF VIEWING WANDS
Manufacturer
I.S.G. TECHNOLOGIES, INC.
Date Cleared
1997-06-04
(86 days)
Product Code
HAW, 84H
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
I.S.G. TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Family of Viewing Wands, (including cranial and spinal applications) is comprised of a medical workstation and an integrated position sensing probe, is intended to be used pre-operatively and intraoperatively to perform the following functions:
- process and display pre-operatively radiographic images on a monitor; .
- provide intra-operative image information based on the position and orientation of a user directed . probe:
- allow for the optical integration and usage of different position sensing technologies (e.g. articulated arm, infrared freehand) and surgical probes (handheld pointers);
- store/retrieve image data on computer access media (e.g. hard disks, archive media); and
- transmit data over local area and wide area networks.
The Family of Viewing Wands is intended to be used pre-operatively:
- when more than one approach (e.g. entry point, transtony, craniotomy size, screw placement) is being considered:
- when determining the size of any instrumentation:
and intra-operatively, when:
- the target, trajectory, or approach is in a region with few anatomical landmarks (e.g. subcortical brain) or with complex anatomy (e.g. scoliosis, fractures, deformity);
- the target, traiectory, or approach is not entirely exposed (e.g. costerior approach for screw placement):
- the target, trajectory, or approach is in a region where the normal landmarks have been distorted either by disease (e.g. degenerative disease, osteophytes) or by previous surgery;
- the target, trajectory, or approach is in close proximity to critical structures (e.g. venous sinuses, air sinuses, spinal nerve roots or blood vessels) which must be avoided or negotiated; or
- a the target's delineation is important and will not move significantly during the approach (e.g. skull based tumors, sinus diseases, corpus callosotomies, spinal cord tumors).
The Family of Viewing Wands is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head.
It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations in the spine.
The Family of Viewing Wands is contraindicated for patients suspected of having Creutzfeld-Jakob's disease if adequate sterilization of the instrument cannot be assured.
Device Description
The ISG Family of Viewing Wands is comprised of a medical imaging workstation that is integrated with a position-sensing user directed probe. This allows for the provision of information pertaining to the current position of the probe related to the surrounding anatomy by correlating pre-operative CT and/or MR imaging data with the intraoperative situation. Once a patient's CT or MR images have been transferred to the workstation, the patient is correlated to that image dataset. The system then displays the orientation of the probe and the position of the tip on the corresponding image, updating the display in real-time as the probe is moved.
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K Number
K960714Device Name
ISG VIEWING WAND
Manufacturer
I.S.G. TECHNOLOGIES, INC.
Date Cleared
1996-05-29
(98 days)
Product Code
HAW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
I.S.G. TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The ISG Family of Viewing Wands is comprised of a medical imaging workstation that is integrated with a position-sensing user directed probe. This allows for the provision of information pertaining to the current position of the probe related to the surrounding anatomy by correlating pre-operative CT and/or MR imaging data with the intra-operative situation. Once a patient's CT or MR images have been transferred to the workstation, the patient is correlated to that image dataset. The system then displays the orientation of the probe and the position of the tip on the corresponding image, updating the display in real-time as the probe is moved.
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