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510(k) Data Aggregation
K Number
K121479Device Name
AIM
Manufacturer
INNEROPTIC TECHNOLOGY, INC
Date Cleared
2012-09-13
(118 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
INNEROPTIC TECHNOLOGY, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AM is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a stereoscopic computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualizing such procedures.
Device Description
AM is an accessory to ultrasound systems that provides guidance for the placement of needles or needle-like rigid objects, such as biopsy needles and ablation probes. The system enables a physician to accurately place a needle into a target anatomical structure by overlaying the image of the needle and its predicted future path on the ultrasound image of the internal organs in real time on a stereo monitor, for a "3D" effect (cf. IMAX 3D theaters). AIM consists of four (4) principal components: an electromagnetic position tracking system; tracking sensors and mounts for the ultrasound transducer and the needle; custom guidance software installed on a computer; and a stereoscopic monitor with passive glasses for viewing the monitor.
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K Number
K083728Device Name
INVISION SYSTEM
Manufacturer
INNEROPTIC TECHNOLOGY, INC
Date Cleared
2009-08-12
(239 days)
Product Code
IYO, OEW
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
INNEROPTIC TECHNOLOGY, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InVision System is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a stereoscopic computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualizing such procedures.
Device Description
The InVision System is an accessory to ultrasound systems that provides guidance for the placement of needle-like rigid objects, such as biopsy needles and ablation probes. The system enables a physician to accurately place a needle into a target anatomical structure by overlaying the image of the needle and its predicted future path on the ultrasound image of the internal organs in real time on a stereo monitor, for a "3D" effect (cf. IMAX 3D theaters).
The InVision System consists of four (4) principal components:
- a passive infrared position tracking system; (1)
- (2) tracking mounts for the ultrasound transducer and the needle;
- custom guidance software installed on a computer; and (3)
- (4) a stereoscopic monitor with passive glasses for viewing the monitor.
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