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510(k) Data Aggregation
K Number
K061437Device Name
SIGMA 5000 SERIES, IMAGIC
Manufacturer
Date Cleared
2006-06-14
(21 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
KONTRON MEDICAL SYSTEMS SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation
---|---
Fetal | B, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
Abdominal | B, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
Pediatric | B, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
Small organs (Thyroid, Breast, Testicle) | B, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
Adult Cephalic | B, M, PW D, CW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
Cardiac | B, M, PW D, CW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
Transesophageal | B, M, PW D, CW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
Transrectal | B, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
Transvaginal | B, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
Peripheral Vascular | B, M, PW D, CW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
Musculo-skeletal Conventional | B, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
Musculo-skeletal Superficial | B, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
Device Description
The Sigma 5000 series, Imagic is a medical diagnostic ultrasound imaging system. This submission adds an Adult Cephalic (Adult Transcranial) indication for use to the system, which was previously cleared with other diagnostic ultrasound investigations including Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode). The submission also includes several transducers for use with the system.
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K Number
K053084Device Name
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
Manufacturer
Date Cleared
2005-11-16
(14 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
KONTRON MEDICAL SYSTEMS SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continous wave Doppler (CW Doppler), Color Flow Mapping (CFM) adn Color Time motion (CM mode).
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small organs (Thyroid, Breast, Testicle), Cardiac, Transesophageal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
Device Description
The Sigma 5000 series, Imagic is an ultrasound instrument intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode). The submission also includes the transducers necessary for these procedures. The system is a mobile console approximately 60 cm wide, 95 cm deep and 130 cm high equipped with a keyboard control panal, a large TFT screen, assorted transducers and image storage or hard-copy devices.
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K Number
K050099Device Name
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
Manufacturer
Date Cleared
2005-01-28
(10 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
KONTRON MEDICAL SYSTEMS SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small organs (Thyroid, Breast, Testicle), Cardiac, Transesophageal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Modes of Operation: B, M, PW D, CW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD).
Device Description
The Sigma 5000 series, Imagic is an ultrasound instrument intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode). The submission also includes the transducers necessary for these procedures. The system is a mobile console approximately 60 cm wide, 95 cm deep and 130 cm high equipped with a keyboard control panal, a large TFT screen, assorted transducers and image storage or hard-copy devices.
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K Number
K002239Device Name
SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
Date Cleared
2000-08-08
(15 days)
Product Code
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
KONTRON MEDICAL SYSTEMS SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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