510(k) · Cleared
ClearedPortray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surround Medical Systems · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Jul 28, 2021 as substantially equivalent to K182206 (Trident S.R.L, 2018) after a 114-day review. Its family tree reaches back 6 generations to 1994. 1 later device descends from it.
- Decided
- Jul 28, 2021
- Review
- 114 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K935046 (1994). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK935046 GX-770 X-Ray Control, Model 46-404600G4Gendex Corp. · 1994
- 5 generations backK043092 Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015Progeny, Inc. · 2004
- 4 generations backK083344 Heliodent PlusSirona Dental Systems GmbH · 2008
- 3 generations backK120318 Vivi Ergon-X HFVivi S.R.L. · 2012
- 2 generations backK163519 RX DCCefla S.C. · 2017
- 1 generation backK182206 RiX70 DCTrident S.R.L · 2018
- This deviceK211014 PortraySurround Medical Systems · 2021
- Descendant · cites it directly · 0 of its ownK223780 Lumos 3DX3Dio · 2023
Most influential descendants
Showing 1 of 1 · See all- K223780Lumos 3DX3Dio · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935046 | GX-770 X-Ray Control, Model 46-404600G4 | Gendex Corp. | 1994 | — |
| −5 | K043092 | Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015 | Progeny, Inc. | 2004 | — |
| −4 | K083344 | Heliodent Plus | Sirona Dental Systems GmbH | 2008 | — |
| −3 | K120318 | Vivi Ergon-X HF | Vivi S.R.L. | 2012 | — |
| −2 | K163519 | RX DC | Cefla S.C. | 2017 | — |
| −1 | K182206 | RiX70 DC | Trident S.R.L | 2018 | — |
| 0 (this device) | K211014 | Portray | Surround Medical Systems | 2021 | — |
| +1 | K223780 | Lumos 3DX | 3Dio | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 EHD? 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 EHD device
- #1 K260795 Hand-held Dental X-ray System (HyperLight-M)score 14.1 · 8 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 |
|---|---|---|---|
| * | K182206 | RiX70 DCSummary page 4…ray system Class: II Product Code: EHD Predicate Device(s): RiX70 DC, K182206 Device Description: The Portray System, an extraoral X-ray source (intraoral X-ra… | 2018 |
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 |
|---|---|---|---|
| K223780 | Lumos 3DX | 2023 | 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?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K223780 (3Dio, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K182206.
How does its category compare?
All EHD devicesEHD Unit, X-Ray, Extraoral With Timer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · EHD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EHD
58in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EHD
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EHD
6in 2024
MAUDE reports naming product code EHD, 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 | 1 | — | 0 | 5 |
| 2008 | 5 | 49 | 0 | 6 |
| 2009 | 4 | 92 | 0 | 38 |
| 2010 | 4 | 268 | 3 | 47 |
| 2011 | 3 | 102 | 3 | 26 |
| 2012 | 2 | — | 0 | 22 |
| 2013 | 4 | 216 | 0 | 21 |
| 2014 | 3 | 107 | 1 | 20 |
| 2015 | 1 | — | 0 | 110 |
| 2016 | 2 | — | 1 | 63 |
| 2017 | 4 | 28 | 1 | 66 |
| 2018 | 5 | 30 | 0 | 21 |
| 2019 | 4 | 173 | 0 | 21 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 8 | 58 | 0 | 4 |
| 2023 | 8 | 147 | 0 | 2 |
| 2024 | 7 | 58 | 0 | 6 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 128 | 0 | — |
What is it indicated for?
The Portray System is an extraoral X-ray source (intraoral X-ray detection) dental X-ray system for producing diagnostic dental radiographs of the teeth, jaw, and other oral structures. The system provides 2D imaging for diagnostic purposes and 3D imaging as an adjunctive tool.
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/K211014 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211014: Portray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211014
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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