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Multi-Plane Transesophageal Transducer Pei-514VX

by Canon Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04987670106309 UDI-DI Date29 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Multi-Plane Transesophageal Transducer
Generic Name
Oesophageal ultrasound imaging transducer, reusable
Model / Reference
PEI-514VX
Primary DI / UDI-DI
04987670106309
510(k) Number
FDA Product Code
ITX
GMDN Term
Oesophageal ultrasound imaging transducer, reusable
Device Class
Class II
Regulation Number
892.1570
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K242808)

Other devices from Canon Inc.

See all devices from Canon Inc. →

Properties

  • Serial Number

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No