510(k) · Cleared
ClearedSiui Apogee 800PLUS Ultrasound Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shantou Institute of Ultrasonic Instuments · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Nov 1, 1999 as substantially equivalent to K903603 (Advanced Technology Laboratories, Inc., 1991) and 1 other predicate after a 342-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Nov 1, 1999
- Review
- 342 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K903603 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK903603 Ultramark 9 Ultrasound System (UM 9)Advanced Technology Laboratories, Inc. · 1991
- This deviceK984203 Siui Apogee 800PLUS Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903603 | Ultramark 9 Ultrasound System (UM 9) | Advanced Technology Laboratories, Inc. | 1991 | — |
| 0 (this device) | K984203 | Siui Apogee 800PLUS Ultrasound Imaging System | Shantou Institute of Ultrasonic Instuments | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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? (2)
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 |
|---|---|---|---|
| * | K903603 | Ultramark 9 Ultrasound System (UM 9)Summary page 1…ident Telephone: (86) 754-8250150 Fax: (86) 754-8251499 Establishment Registration Number: 9615439 Predicate: Advanced Technology Laboratories, Ultramark 9 HDI system, K903603 and Interspec Inc Apogee RX 400, K924231 Device Description: Apogee 800 PLUS transmits ultrasound waves, receives the echoes, an… | 1991 |
| * | K924231 | Interspec Apogee ClaSummary page 1…6) 754-8251499 Establishment Registration Number: 9615439 Predicate: Advanced Technology Laboratories, Ultramark 9 HDI system, K903603 and Interspec Inc Apogee RX 400, K924231 Device Description: Apogee 800 PLUS transmits ultrasound waves, receives the echoes, and generates images based on information c… | 1993 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K903603.
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.
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?
Ultrasonic pulsed echo imaging, measurement, color Doppler, and color velocity imaging for Fetal, Abdominal, Pediatric, Small Organ, and Peripheral Vascular.
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/K984203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984203: Siui Apogee 800PLUS Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984203
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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