510(k) · Cleared
Recalled · Class II · 2025Ultrasound System 1300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bk Medical Aps · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Oct 23, 2023 as substantially equivalent to K173569 (Bk Medical Aps, 2018) after a 129-day review. Its family tree reaches back 16 generations to 1989. It has been recalled once.
- Decided
- Oct 23, 2023
- Review
- 129 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 16 generations to K894632 (1989). 135 ancestors in all. No later device cites it as a predicate yet.
- Root · 16 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 12 generations between
- 3 generations backK103629 Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C · 2011
- 2 generations backK161960 bk2300Bk Medical Aps · 2016
- 1 generation backK173569 Ultrasound System 1300Bk Medical Aps · 2018
- This deviceK231764 Ultrasound System 1300Bk Medical Aps · 2023
Show all 16 generations
- Root · 16 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 15 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 14 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 13 generations backK991858 Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999
- 12 generations backK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
- 11 generations backK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
- 10 generations backK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003
- 9 generations backK063130 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · Recalled
- 8 generations backK072000 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C · 2007
- 7 generations backK081065 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2Toshiba America Medical Systems, In.C · 2008
- 6 generations backK082119 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C · 2008
- 5 generations backK091295 Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C · 2009 · Recalled
- 4 generations backK092179 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version…Toshiba America Medical Systems, In.C · 2009 · Recalled
- 3 generations backK103629 Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C · 2011
- 2 generations backK161960 bk2300Bk Medical Aps · 2016
- 1 generation backK173569 Ultrasound System 1300Bk Medical Aps · 2018
- This deviceK231764 Ultrasound System 1300Bk Medical Aps · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −15 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −14 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −13 | K991858 | Ssa-390A/Power Vision 8000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −12 | K013633 | Ssa-770A, Aplio Ultrasound System | Toshiba America Medical Systems, In.C | 2001 | — |
| −11 | K022400 | Ssa-700A, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2002 | 1 |
| −10 | K032281 | Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2003 | — |
| −9 | K063130 | Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0 | Toshibamedical Systems Corporation | 2006 | 1 |
| −8 | K072000 | Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0 | Toshiba America Medical Systems, In.C | 2007 | — |
| −7 | K081065 | Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2 | Toshiba America Medical Systems, In.C | 2008 | — |
| −6 | K082119 | Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0 | Toshiba America Medical Systems, In.C | 2008 | — |
| −5 | K091295 | Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0 | Toshiba America Medical Systems, In.C | 2009 | 2 |
| −4 | K092179 | Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001 | Toshiba America Medical Systems, In.C | 2009 | 1 |
| −3 | K103629 | Pet-512MC Transesophageal Transducer | Toshiba America Medical Systems, In.C | 2011 | — |
| −2 | K161960 | bk2300 | Bk Medical Aps | 2016 | — |
| −1 | K173569 | Ultrasound System 1300 | Bk Medical Aps | 2018 | — |
| 0 (this device) | K231764 | Ultrasound System 1300 | Bk Medical Aps | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 8 | 0 |
| 1996 | 2 | 0 |
| 1997 | 8 | 0 |
| 1998 | 3 | 0 |
| 1999 | 10 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 14 | 0 |
| 2005 | 11 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K173569 | Ultrasound System 1300Summary page 5…ation of Predicate or Legally Marketed Devices: • Primary predicate device: Ultrasound System 1300 as cleared under 510(k) premarket notification No K173569. Trade Name: Ultrasound System 1300 Common Name: Ultrasound System… | 2018 |
| † | K223830 | Ultrasound System 2300 | 2023 |
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 |
|---|---|---|---|---|
| Oct 9, 2025 | Class II | Z-0436-2026 | Device Design | GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 34 of the 135 ancestors have a recall of any class.
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. 2023, 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?
The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance. The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult trans-cranial), Neonatal Cephalic, Intra-operative, Intra-operative…
Read the full statement (174 words)
The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.
The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult trans-cranial), Neonatal Cephalic, Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, and Peripheral Vessel (also known as Peripheral Vascular).
Modes of Operation:
* 2D (B-Mode) (including Tissue Harmonic imaging)
» M-Mode
* Vector Flow Imaging (VFI)
» Strain Elastography
» CW Doppler
* Contrast Imaging
* PWD Mode
* CFM Mode (Includes Color Doppler and Amplitude (Power) Doppler)
Environment:
The Ultrasound System 1300 is intended for use in the professional healthcare environment (e.g. hospitals, physician offices)
Contraindications:
The Ultrasound System 1300 is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.
The Cardiac Adult application is not intended for direct use on the heart.
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/K231764 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231764: Ultrasound System 1300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231764
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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