510(k) · Cleared
ClearedUltra Image and Ultra Scan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonotech, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Aug 21, 1998 as substantially equivalent to K883917 (Sonomed Technology, Inc., 1989) and 2 other predicates after a 155-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Aug 21, 1998
- Review
- 155 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K883917 (1989). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK883917 Natural Image Ultrasound Transmission CouplantSonomed Technology, Inc. · 1989
- This deviceK981028 Ultra Image and Ultra ScanSonotech, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883917 | Natural Image Ultrasound Transmission Couplant | Sonomed Technology, Inc. | 1989 | — |
| 0 (this device) | K981028 | Ultra Image and Ultra Scan | Sonotech, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 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
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K883917 | Natural Image Ultrasound Transmission CouplantSummary page 2…ng gel Regulatory Classification: 11 Legally marketed devices to which we claim equivalence (see Comparison Table for further information): Natural Image Scanning Gel, K883917/B, reviewed and clearance received 3/31/89 Clear Image Sterile Scanning Gel, K931909, reviewed and clearance received 3/21/94 So… | 1989 |
| * | K931909 | Clear Image Sterile Diagnostic Ultrsound GelSummary page 2…ivalence (see Comparison Table for further information): Natural Image Scanning Gel, K883917/B, reviewed and clearance received 3/31/89 Clear Image Sterile Scanning Gel, K931909, reviewed and clearance received 3/21/94 SonoMix Scanning Gel, K931908/S1, reviewed and clearance received 12/13/94 Description… | 1994 |
| * | K931908 | Sonoquick Ultrasound GelSummary page 2…canning Gel, K883917/B, reviewed and clearance received 3/31/89 Clear Image Sterile Scanning Gel, K931909, reviewed and clearance received 3/21/94 SonoMix Scanning Gel, K931908/S1, reviewed and clearance received 12/13/94 Description: Sono Image and Ultra Glide are medical diagnostic ultrasound scanning… | 1994 |
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 3 ancestors has a recall.
- 1 other device also cites its predicate K883917.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 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?
Sono Image and Ultra Glide are coupling gels and will be used in conjunction with ultrasound transducers during medical diagnostic ultrasound to couple sound waves into the patient's body.
Sono Image is a high viscosity scanning gel suitable for echocardiography, vascular sonography, vascular sonography and general ultrasound scanning procedures.
Ultra Glide is a low viscosity scanning gel suitable for abdominal, OB/GYN and general ultrasound scanning procedures.
Note: viscosity does not affect the safety or performance of a scanning gel. Scanning gels are selected by sonographers based on viscosity preference.
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/K981028 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981028: Ultra Image and Ultra Scan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981028
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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