510(k) · Cleared
ClearedDicom Image Manager, Model 3-D Visualization Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dicomit Imaging Systems Corp. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 16, 1999 as substantially equivalent to K951925 (Dicomit Imaging Systems Corp., 1995) and 2 other predicates after an 80-day review. Its family tree reaches back 2 generations to 1994. 213 later devices descend from it.
- Decided
- Apr 16, 1999
- Review
- 80 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K930768 (1994). 4 ancestors in all. 213 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK930768 Orion Diagnostic Ultrasound SystemGE Medical Systems · 1994
- 1 generation backK964617 GE Logiq 700 Diagnostic Ultrasound SystemGE Medical Systems · 1997
- This deviceK990248 Dicom Image Manager, Model 3-D Visualization OptionDicomit Imaging Systems Corp. · 1999
- Descendant · cites it directly · 212 of its ownK992886 Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C · 1999
- Descendant · 2 generations on · 211 of its ownK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
- Descendant · 2 generations on · 210 of its ownK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
- Descendant · 3 generations on · 209 of its ownK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003
- Descendant · 4 generations on · 205 of its ownK063130 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · Recalled
Showing 5 of 213 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 213 · See all- K992886Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C · 1999 · cites it directly212descendants
- K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001 · 2 generations on211descendants
- K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · 2 generations on210descendants
- K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003 · 3 generations on209descendants
- K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · 4 generations on205descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930768 | Orion Diagnostic Ultrasound System | GE Medical Systems | 1994 | — |
| −1 | K964617 | GE Logiq 700 Diagnostic Ultrasound System | GE Medical Systems | 1997 | — |
| 0 (this device) | K990248 | Dicom Image Manager, Model 3-D Visualization Option | Dicomit Imaging Systems Corp. | 1999 | — |
| +1 | K992886 | Powerview Ultrasound Workstation, Uidm-400A | Toshiba America Medical Systems, In.C | 1999 | — |
| +2 | K013633 | Ssa-770A, Aplio Ultrasound System | Toshiba America Medical Systems, In.C | 2001 | — |
| +2 | K022400 | Ssa-700A, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2002 | 1 |
| +3 | K032281 | Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2003 | — |
| +4 | K063130 | Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0 | Toshibamedical Systems Corporation | 2006 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 4 | 0 |
| 2014 | 10 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 12 | 0 |
| 2018 | 18 | 0 |
| 2019 | 8 | 0 |
| 2020 | 20 | 0 |
| 2021 | 9 | 0 |
| 2022 | 16 | 0 |
| 2023 | 18 | 0 |
| 2024 | 13 | 0 |
| 2025 | 26 | 0 |
| 2026 | 13 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K951925 | DicomitSummary page 1…ame: Ultrasonic Pulsed Echo Imaging System (3) ldentification of predicate devices: Manufacturer Device 510(k) Number Dicomit Imaging Systems Corp. Dicom Image Manager K951925 Advanced Technology Labs ATL HDI 3000/5000 Ultrasound systems K961459 General Electric Medical Systems GE LOGIQ 700 Ultrasound sy… | 1995 |
| * | K961459 | Level 10 HdiSummary page 1…icate devices: Manufacturer Device 510(k) Number Dicomit Imaging Systems Corp. Dicom Image Manager K951925 Advanced Technology Labs ATL HDI 3000/5000 Ultrasound systems K961459 General Electric Medical Systems GE LOGIQ 700 Ultrasound system K964617 (4) Description of the device: The software changes des… | 1997 |
| * | K964617 | GE Logiq 700 Diagnostic Ultrasound SystemSummary page 1…s Corp. Dicom Image Manager K951925 Advanced Technology Labs ATL HDI 3000/5000 Ultrasound systems K961459 General Electric Medical Systems GE LOGIQ 700 Ultrasound system K964617 (4) Description of the device: The software changes described in this submission enable the DICOMIT Dicom Image Manager - with… | 1997 |
What descends from it? (213)
See all 2131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992886 | Powerview Ultrasound Workstation, Uidm-400A | 1999 | 212 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K992886 (Toshiba America Medical Systems, In.C, 1999) has gone furthest, with 212 descendants of its own.
- 1 other device also cites its predicate K951925.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The DICOMIT Dicom Image Manager medical image management system is intended for acceptance, transfer, display, storage and digital processing of medical images. The software component provides functions for performing operations related to image manipulation.
The "3D ROI" software option enables the device to display and manipulate an adjunctive 3D volume image created with data from a diagnostic ultrasound scanning procedure.
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/K990248 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990248: Dicom Image Manager, Model 3-D Visualization Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990248
Report an extraction error
Are you the manufacturer?
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