510(k) · Cleared
Recalled · Class II · 2016Touch Ultrasound
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 9, 2015 as substantially equivalent to K043524 (B-K Medical A/S, 2005) and 4 other predicates after a 100-day review. Its family tree reaches back 4 generations to 2000. It has been recalled 2 times.
- Decided
- Dec 9, 2015
- Review
- 100 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 4 generations to K000567 (2000). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK000567 Ultrasound Scanner Type 2102B & K Medical A/S · 2000 · Recalled
- 3 generations backK024236 Ultrasound Scanner, Type 2400B-K Medical A/S · 2003 · Recalled
- 2 generations backK043524 Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S · 2005 · Recalled
- 1 generation backK100919 Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202B-K Medical Aps · 2011
- This deviceK152467 Touch UltrasoundCarestream Health, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000567 | Ultrasound Scanner Type 2102 | B & K Medical A/S | 2000 | 1 |
| −3 | K024236 | Ultrasound Scanner, Type 2400 | B-K Medical A/S | 2003 | 2 |
| −2 | K043524 | Ultrasound Scanner Pro Focus, Model 2202 | B-K Medical A/S | 2005 | 1 |
| −1 | K100919 | Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202 | B-K Medical Aps | 2011 | — |
| 0 (this device) | K152467 | Touch Ultrasound | Carestream Health, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043524 | Ultrasound Scanner Pro Focus, Model 2202Summary page 11…0) Diagnostic Ultrasonic Transducer (90 ITX, CFR 892.1570) Identification of predicate, legally marketed devices: B-K Medical Ultrasound Scanner Pro Focus 2202, K043524 B-K Medical Ultrasound Scanner Pro Focus 2202, K100919 BK Medical Ultrasound Scanner bk2300, K140428 Carestream Health Touch Ultr… | 2005 |
| * | K100919 | Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202Summary page 11…R 892.1570) Identification of predicate, legally marketed devices: B-K Medical Ultrasound Scanner Pro Focus 2202, K043524 B-K Medical Ultrasound Scanner Pro Focus 2202, K100919 BK Medical Ultrasound Scanner bk2300, K140428 Carestream Health Touch Ultrasound, K150342 Siemens Ultrasound Scanner System Acuso… | 2011 |
| * | K140428 | Ultrasound Scanner System BK2300Summary page 11…lly marketed devices: B-K Medical Ultrasound Scanner Pro Focus 2202, K043524 B-K Medical Ultrasound Scanner Pro Focus 2202, K100919 BK Medical Ultrasound Scanner bk2300, K140428 Carestream Health Touch Ultrasound, K150342 Siemens Ultrasound Scanner System Acuson S1000, K130619 Device description: Ultrasou… | 2014 |
| * | K150342 | Touch UltrasoundSummary page 11…Scanner Pro Focus 2202, K043524 B-K Medical Ultrasound Scanner Pro Focus 2202, K100919 BK Medical Ultrasound Scanner bk2300, K140428 Carestream Health Touch Ultrasound, K150342 Siemens Ultrasound Scanner System Acuson S1000, K130619 Device description: Ultrasound scanner and transducers for B, Tissue and… | 2015 |
| * | K130619 | Acuson S1000 Diagnostic Ultrasound SystemSummary page 11…Scanner Pro Focus 2202, K100919 BK Medical Ultrasound Scanner bk2300, K140428 Carestream Health Touch Ultrasound, K150342 Siemens Ultrasound Scanner System Acuson S1000, K130619 Device description: Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler,… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2016 | Class II | Z-1052-2017 | Software design | Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulting measurement unit is not displayed, i.e., centimeters or… |
| Jul 8, 2016 | Class II | Z-2217-2016 | Software design | A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. For example, measurement results of the anatomy may appear enlarged or distended when it… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 4 of the 10 ancestors have a recall of any class.
- 4 other devices also cite its predicate K043524.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152467 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152467: Touch Ultrasound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152467
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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