510(k) · Cleared

Cleared

Broadsound, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B

K070195510(k) AbbreviatedCleared Oct 15, 2007266-day reviewClass II21 CFR 892.1570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Broadsound Corporation · ITX Transducer, Ultrasonic, Diagnostic

Cleared on Oct 15, 2007 as substantially equivalent to K900805 (Ge Medical Systems Information Technologies, 1990) and 4 other predicates after a 266-day review. Its family tree reaches back 2 generations to 1997.

Decided: Oct 15, 2007
Review: 266 days
Class: Class II
Product code: ITX
Recalls: None
Predicates: 6

Its longest line of descent runs back 2 generations to K961459 (1997). 5 ancestors in all, the oldest K900805 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK961459 Level 10 HdiAdvanced Technology Laboratories, Inc. · 1997
1 generation backK974269 SA8800 Diagnostic Ultrasound System and Transducers,Medison America, Inc. · 1998
This deviceK070195 Broadsound, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B…Broadsound Corporation · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K961459	Level 10 Hdi	Advanced Technology Laboratories, Inc.	1997	—
−1	K974269	SA8800 Diagnostic Ultrasound System and Transducers,	Medison America, Inc.	1998	—
0 (this device)	K070195	Broadsound, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B…	Broadsound Corporation	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1999	1	0
2000	1	0

FIG. 1 — Lineage of K070195, 1997–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ITX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new ITX device

#1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (9)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K900805	Aloka 500 Diagnostic Ultrasound Scanning System Summary page 9 …Conventional Musculo-skeletal Superficial Other (specify) N = new indication; P = previously cleared by FDA under K900805 and K880900; E added under Appendix E Note 1: Combined application includes B/M mode.…	Ge Medical Systems Information Technologies	1990	—
Kept off the family tree	K880900	FDA’s K880900 is SSD-620 Linear/Convex Array Sector Scanner 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 …ventional Musculo-skeletal Superficial Other (specify) N = new indication; P = previously cleared by FDA under K900805 and K880900; E added under Appendix E Note 1: Combined application includes B/M mode.…	Corometrics Medical Systems, Inc.	1988	—
*	K983879	Aloka SSD-900 Diagnostic Ultrasound System Summary page 2 …-934N-3.5 Aloka Ltd. A-71-50A K<900805, K<880900 UST-5512U--7.5 Aloka Ltd. AL3C79B K983879 UST-979-3.5 Aloka Ltd. AI-71-2413 K983879 UST-5524-…	Aloka Co., Ltd.	1999	—
*	K002003	Hdi 5000 Ultrasound System with Extended Field of View Imaging Summary page 13 …____ Conventional Musculo-skeletal N - new indication; P =previously cleared by FDA under K002003; E added under Appendix E Note I: Combined application includes B/M mode. Note 2: Combined applicatio…	Atl Ultrasound, Inc.	2000	—
*	K974269	SA8800 Diagnostic Ultrasound System and Transducers, Summary page 16 …Conventional Musculo-skeletal Superficial Other (specify) N = new indication; P = previously cleared by FDA under K974269 & K961459; E = added under Appendix E Note I: Combined application includes B/M mode. Note 2: Combined appl…	Medison America, Inc.	1998	—
*	K961459	Level 10 Hdi Summary page 16 …onventional Musculo-skeletal Superficial Other (specify) N = new indication; P = previously cleared by FDA under K974269 & K961459; E = added under Appendix E Note I: Combined application includes B/M mode. Note 2: Combined applications i…	Advanced Technology Laboratories, Inc.	1997	—
*	—	C4-2 Named without a submission number			—
*	—	ATL P3-2 Named without a submission number			—
*	—	ATL P4-2 Named without a submission number			—

Also cleared against K900805: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
None of the 5 ancestors has a recall.
3 other devices also cite its predicate K900805.

How does its category compare?

All ITX devices

ITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · ITX

4in 2025

2007high 17 (2009) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITX

126in 2025

2007high 213 (2023) · low 16 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ITX

2in 2025

2007high 15 (2018) · low 0 (2007)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · ITX

571in 2025

2007high 988 (2024) · low 16 (2007)2025

MAUDE reports naming product code ITX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	10	26	0	16
2008	12	73	4	39
2009	17	28	4	23
2010	10	42	4	30
2011	10	16	1	34
2012	7	25	1	29
2013	3	105	0	38
2014	4	41	1	43
2015	1	—	5	183
2016	4	151	0	269
2017	6	110	1	412
2018	2	—	15	130
2019	1	—	0	119
2020	3	120	3	116
2021	3	139	10 (10)	146
2022	2	—	6	87
2023	6	213	1	138
2024	3	81	1	988
2025	4	126	2	571
2026	6	158	0	—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070195 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070195: Broadsound, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070195

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026