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ArcScan Insight 100 EyeSeal Disposable

by Arcscan, Inc.

ArcScan Insight 100 EyeSeal Disposable (ED1) is an ophthalmic ultrasound imaging system (FDA Class II) made by Arcscan, Inc., listed in FDA GUDID since 4 Oct 2016 (UDI-DI B017ED102), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB017ED102 UDI-DI Date4 Oct 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
ArcScan Insight 100
Generic name
Ophthalmic ultrasound imaging system
Model / Ref / Catalog
EyeSeal Disposable, ED1
Primary DI / UDI-DI
B017ED102
FDA product code
ITX, IYO
GMDN term
Ophthalmic ultrasound imaging system
Device class
Class II
Regulation number
892.1570, 892.1560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic ultrasound imaging system

Similar devices in this category

Other devices filed under Ophthalmic ultrasound imaging system.

Other devices from Arcscan, Inc.

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)