# K062571: Longport Episcan, Model-I-200

- Pathway: 510(k) (Traditional)
- Applicant: Longport, Inc.
- Decided: Nov 21, 2006 after 82 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Longport LDS-1: named in the summary without a submission number
- (no number) Hudson 2020, 2040, 2060 Ultrasound Scanner: named in the summary without a submission number
- (no number) Diasus, Diagnostic Ultrasound System: named in the summary without a submission number
- (no number) P75LHF, 5-12MHz Ultra wideband Linear Array Probe: named in the summary without a submission number
- (no number) Cortex DermaScan C Ultrasonic Transducer: named in the summary without a submission number
- (no number) Cortex DermaScan C Ultrasonic System: named in the summary without a submission number

## Most influential descendants
- K160674: Fujifilm Sonosite Vevo MD Imaging System (2016), 6 descendants of its own
- K190476: FUJIFILM Sonosite Vevo MD Imaging System (2019), 4 descendants of its own
- K233112: HM70 EVO Diagnostic Ultrasound System (2023), 2 descendants of its own
- K254099: EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System (2026), 1 descendant of its own
- K263182: EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K062571
Methodology: https://510kreport.com/methodology