510(k) · Cleared
Recalled · Class II · 2024EnVisio Navigation Sytem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elucent Medical, Inc. · NEU Marker, Radiographic, Implantable
Cleared on Mar 22, 2019 as substantially equivalent to K181007 (Cianna Medical, Inc., 2018) after a 105-day review. Its family tree reaches back 1 generation to 2018. It has been recalled once.
- Decided
- Mar 22, 2019
- Review
- 105 days
- Class
- Class II
- Product code
- NEU
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K181007 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backK181007 Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc. · 2018
- This deviceK183400 EnVisio Navigation SytemElucent Medical, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. | 2018 | — |
| 0 (this device) | K183400 | EnVisio Navigation Sytem | Elucent Medical, Inc. | 2019 | — |
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 NEU? 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 NEU device
- #1 K240042 MOLLI 2 Systemscore 14.4 · 12 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 |
|---|---|---|---|
| * | K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout SystemSummary page 4…ral and Plastic Surgery 3. PREDICATE DEVICE (PRIMARY) Trade Name: Cianna Medical SAVI Scout Reflector and SAVI Scout System 510(k) K181007 Common Name: Implanted, Radiographic, Tissue Marker Classification Number: 21 CFR 878.4300 Classificatio… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2024 | Class II | Z-0806-2025 | Device Design | There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K181007.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NEU
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEU
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEU
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NEU
411in 2025
MAUDE reports naming product code NEU, 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 | 4 | 94 | 0 | 5 |
| 2008 | 7 | 107 | 0 | 5 |
| 2009 | 4 | 70 | 0 | 30 |
| 2010 | 5 | 69 | 0 | 12 |
| 2011 | 3 | 145 | 1 | 18 |
| 2012 | 3 | 120 | 0 | 54 |
| 2013 | 7 | 49 | 0 | 60 |
| 2014 | 3 | 48 | 0 | 38 |
| 2015 | 7 | 111 | 0 | 120 |
| 2016 | 2 | — | 0 | 56 |
| 2017 | 4 | 115 | 1 | 69 |
| 2018 | 8 | 89 | 0 | 66 |
| 2019 | 5 | 149 | 0 | 58 |
| 2020 | 3 | 169 | 0 | 45 |
| 2021 | 3 | 46 | 0 | 82 |
| 2022 | 2 | — | 1 | 100 |
| 2023 | 4 | 136 | 0 | 142 |
| 2024 | 10 | 267 | 2 (1) | 247 |
| 2025 | 5 | 99 | 2 | 411 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The SmartClip Soft Tissue Marker is intended to be placed percutaneously in soft tissue to permanently mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (EnVisio Navigation System); the SmartClip is located and surgically removed with the target tissue. The EnVisio Navigation System is intended only for the non-imaging detection and localization (by navigation) of the SmartClip that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183400: EnVisio Navigation Sytem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183400
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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