510(k) · Cleared
ClearedModel DGH 6000 Scanmate a
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dgh Technology, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 5, 2010 as substantially equivalent to K872726 (Dgh Technology, Inc., 1987) and 1 other predicate after a 158-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.
- Decided
- Apr 5, 2010
- Review
- 158 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K872726 (1987). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K171301Scanmate FlexDgh Technology, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872726 | DGH-3000A a-Scan | Dgh Technology, Inc. | 1987 | — |
| 0 (this device) | K093371 | Model DGH 6000 Scanmate a | Dgh Technology, Inc. | 2010 | — |
| +1 | K171301 | Scanmate Flex | Dgh Technology, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 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? (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 |
|---|---|---|---|
| * | K872726 | DGH-3000A a-ScanSummary page 2…(800) 722-3883 TFCHNH IC Legally Marketed Predicate Device(s): DGH 3000A Ultrasonic A-Scan (K872726) Quantel Medical AXIS II Ultrasonic Biometer (K000554) Description of Device: The DGH 6000… | 1987 |
| * | K000554 | Pocket Ultrasonic Ophthalmic Pachymeter, Biometry Transducer for PocketSummary page 2…IC Legally Marketed Predicate Device(s): DGH 3000A Ultrasonic A-Scan (K872726) Quantel Medical AXIS II Ultrasonic Biometer (K000554) Description of Device: The DGH 6000 A-Scan is a USB plug-in device that uses A- Mode, pul… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171301 | Scanmate Flex | 2017 | 0 |
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?
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. 2010, this device’s year, is highlighted.
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 intended use of the DGH 6000 is the measurement of AL, ACD, LT of the human eye. The DGH 6000 is also intended to calculate the optical power of an IOL that is to be implanted during cataract surgery. The DGH 6000 is intended to be used solely by qualified medical professionals. Clinical consideration and judgment should be applied when using the DGH 6000. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: The intended…
Read the full statement (124 words)
The intended use of the DGH 6000 is the measurement of AL, ACD, LT of the human eye. The DGH 6000 is also intended to calculate the optical power of an IOL that is to be implanted during cataract surgery. The DGH 6000 is intended to be used solely by qualified medical professionals. Clinical consideration and judgment should be applied when using the DGH 6000.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
The intended use of the DGH 6006 transducer is the measurement of AL, AGO, LT of the human eye. The DGH 6006 transducer is intended to be used solely by qualified medical professionals. Clinical consideration and judgment should be applied when using the DGH 6006 transducer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093371: Model DGH 6000 Scanmate a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093371
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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