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510(k) Data Aggregation
K Number
K070195Device Name
BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B
Manufacturer
Date Cleared
2007-10-15
(266 days)
Product Code
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
BROADSOUND CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The above referenced Broadsound transducer assemblies are intended for use, with standard ultrasound systems, in diagnostic ultrasound imaging or fluid flow analysis of the human body and to be operated by or under the direction of a physician.
Their specific indications for use are listed as following:
| | Model Name | Specific Indications of Use* |
|---|------------|-------------------------------------------------------------|
| 1 | AL3C34A | Abdominal, Fetal |
| 2 | AL7L50A | Small organ, Peripheral vascular |
| 3 | AL3C79B | Abdominal, Fetal, Pediatric |
| 4 | AL7L24B | Small organ, Peripheral vascular |
| 5 | AT3C42B | Abdominal, Fetal, Pediatric |
| 6 | AT3C52B | Abdominal, Fetal, Pediatric |
| 7 | AT5L40B | Abdominal, Pediatric, Peripheral vascular, Musculo-skeletal |
| 8 | AT3P32A | Abdominal, Adult cephalic, Cardiac |
| 9 | AT3P42A | Abdominal, Adult cephalic, Cardiac |
Device Description
The above referenced devices are replacement ultrasound transducers used with standard ultrasound systems. Each of them consists of piezoelectric crystals covered with an acoustic lens, a scan head that fits around the lens, a cable with strain relief devices on both ends, and a connector to attach the transducer to the ultrasound console.
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