# K070195: Broadsound, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B

- Pathway: 510(k) (Abbreviated)
- Applicant: Broadsound Corporation
- Decided: Oct 15, 2007 after 266 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961459 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900805: Aloka 500 Diagnostic Ultrasound Scanning System, Ge Medical Systems Information Technologies (1990) Summary page 9.
- K983879: Aloka SSD-900 Diagnostic Ultrasound System, Aloka Co., Ltd. (1999) Summary page 2.
- K002003: Hdi 5000 Ultrasound System with Extended Field of View Imaging, Atl Ultrasound, Inc. (2000) Summary page 13.
- K974269: SA8800 Diagnostic Ultrasound System and Transducers,, Medison America, Inc. (1998) Summary page 16.
- K961459: Level 10 Hdi, Advanced Technology Laboratories, Inc. (1997) Summary page 16.
- (no number) C4-2: named in the summary without a submission number
- (no number) ATL P3-2: named in the summary without a submission number
- (no number) ATL P4-2: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K880900: SSD-620 Linear/Convex Array Sector Scanner, Corometrics Medical Systems, Inc. (1988). Our reading of the summary gave K880900, FDA’s number for SSD-620 Linear/Convex Array Sector Scanner (Corometrics Medical Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “UST-934N-3.5”. Kept off the family tree. Summary page 9.

## Indications for use
The above referenced devices are replacement ultrasound transducers intended to be used 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: AL3C34A: Abdominal, Fetal AL7L50A: Small organ, Peripheral vascular AL3C79B: Abdominal, Fetal, Pediatric AL7L24B: Small organ, Peripheral vascular AT3C42B: Abdominal, Fetal, Pediatric AT3C52B: Abdominal, Fetal, Pediatric AT5L40B: Abdominal, Pediatric, Peripheral vascular, Musculo-skeletal AT3P32A: Abdominal, Adult cephalic, Cardiac AT3P42A: Abdominal, Adult cephalic, Cardiac

Source page: https://510kreport.com/device/K070195
Methodology: https://510kreport.com/methodology