Search Results
Found 7 results
510(k) Data Aggregation
K Number
K043554Device Name
ULTRASOUND SCANNER MINI FOCUS, MODEL 1402
Manufacturer
B-K MEDICAL A/S
Date Cleared
2005-01-14
(18 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
B-K MEDICAL A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal, Intraoperative, Pediatrics, Transrectal, Small Parts (organ), Transvaginal, Peripheral vascular, Muskulo-skeletal (conventional and superficial).
Device Description
Mini Focus 1402 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode, CFM mode. B mode includes tissue harmonic imaging. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. The system can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. (Freehand tracking). Transducers are linear and convex arrays and mechanical sector.
Ask a Question
K Number
K043524Device Name
ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
Manufacturer
B-K MEDICAL A/S
Date Cleared
2005-01-13
(24 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
B-K MEDICAL A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Neurosurgery, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Musculo-skeletal.
Device Description
Pro Focus 2202 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode, CFM mode. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
Ask a Question
K Number
K024236Device Name
ULTRASOUND SCANNER, TYPE 2400
Manufacturer
B-K MEDICAL A/S
Date Cleared
2003-01-17
(25 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
B-K MEDICAL A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal Doppler, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small Parts (organ s), Transvaginal, Peripheral vascular, Musculo-skeletal.
Device Description
2400 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode and CFM mode. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. Transducers are linear and convex arrays and mechanical sector. The patient contact materials comply with ISO10993-1 All transducers used together with 2400 are Track 3 transducers.
Ask a Question
K Number
K023457Device Name
ULTRASOUND SCANNER, TYPE 1101
Manufacturer
B-K MEDICAL A/S
Date Cleared
2002-11-01
(17 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
B-K MEDICAL A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatrics, Small Organ, Cardiac, Transrectal, Transvaginal, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
Device Description
1101 supports the following scanning modes and combinations thereof: B-mode M-mode. The system can perform simple geometric measurements, and perform calculations in the areas of Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. Transducers are linear and convex arrays and mechanical sector. The patient contact materials comply with ISO10993-1 All transducers used together with 1101 are Track 3 transducers.
Ask a Question
K Number
K011417Device Name
ULTRASOUND SCANNER, TYPE 2102
Manufacturer
B-K MEDICAL A/S
Date Cleared
2001-06-08
(30 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
B-K MEDICAL A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K003986Device Name
ULTRASOUND SCANNER TYPE 2102
Manufacturer
B-K MEDICAL A/S
Date Cleared
2001-04-03
(98 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
B-K MEDICAL A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K003041Device Name
ULTRASOUND SCANNER TYPE 2101
Manufacturer
B-K MEDICAL A/S
Date Cleared
2001-02-07
(131 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
B-K MEDICAL A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1