510(k) · Cleared
ClearedLongport Episcan, Model-I-200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Longport, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Nov 21, 2006 after an 82-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Nov 21, 2006
- Review
- 82 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK062571 Longport Episcan, Model-I-200Longport, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK160674 Fujifilm Sonosite Vevo MD Imaging SystemFUJIFILM Sonosite, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK190476 FUJIFILM Sonosite Vevo MD Imaging SystemFUJIFILM Sonosite, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK233112 HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2023
- Descendant · 4 generations on · 1 of its ownK254099 EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound…Samsung Medison Co., Ltd. · 2026
- Descendant · 5 generations on · 0 of its ownK263182 EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound…Samsung Medison Co., Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K160674Fujifilm Sonosite Vevo MD Imaging SystemFUJIFILM Sonosite, Inc. · 2016 · cites it directly6descendants
- K190476FUJIFILM Sonosite Vevo MD Imaging SystemFUJIFILM Sonosite, Inc. · 2019 · 2 generations on4descendants
- K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2023 · 3 generations on2descendants
- K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd. · 2026 · 4 generations on1descendant
- K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062571 | Longport Episcan, Model-I-200 | Longport, Inc. | 2006 | — |
| +1 | K160674 | Fujifilm Sonosite Vevo MD Imaging System | FUJIFILM Sonosite, Inc. | 2016 | — |
| +2 | K190476 | FUJIFILM Sonosite Vevo MD Imaging System | FUJIFILM Sonosite, Inc. | 2019 | — |
| +3 | K233112 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2023 | — |
| +4 | K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System… | Samsung Medison Co., Ltd. | 2026 | — |
| +5 | K263182 | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System… | Samsung Medison Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 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? (6)
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 |
|---|---|---|---|
| * | — | Longport LDS-1 Named without a submission number | |
| * | — | Hudson 2020, 2040, 2060 Ultrasound Scanner Named without a submission number | |
| * | — | Diasus, Diagnostic Ultrasound System Named without a submission number | |
| * | — | P75LHF, 5-12MHz Ultra wideband Linear Array Probe Named without a submission number | |
| * | — | Cortex DermaScan C Ultrasonic Transducer Named without a submission number | |
| * | — | Cortex DermaScan C Ultrasonic System Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160674 | Fujifilm Sonosite Vevo MD Imaging System | 2016 | 6 |
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?
- Of its descendants, K160674 (FUJIFILM Sonosite, Inc., 2016) has gone furthest, with 6 descendants of its own.
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 EPISCAN 1-200 high resolution ultrasound system is a specialized system for imaging the skin and underlying soft tissue. It is intended for use by clinicians, or under the direction of physicians for imaging and analysis in research environments as well as clinical settings including medical/surgical dermatology assessment and diagnosis (aesthetic and therapeutic), plastic/reconstructive surgical planning, wound assessment and management, skin assessment for pressure ulcer detection and prevention, and superficial musculoskeletal diagnosis.
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/K062571 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062571: Longport Episcan, Model-I-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062571
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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