Skip to content

Convex Array Transducer Pet-835LA

by Canon Inc.

Ref PET-835LAModel PSI-28VX, PET-835LA, PVU-475BT, etc.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4987670A0402RH Basic UDI-DI 04987670106088UDI-DIDate18 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04987670106088 UDI-DI Date24 Jul 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Convex Array Transducer
Generic Name
Surgical ultrasound imaging transducer
Device Name
Transducer for Diagnostic Ultrasound System
Model / Reference
PET-835LA, PSI-28VX, PVU-475BT, etc.
Primary DI / UDI-DI
04987670106088
Basic UDI-DI
4987670A0402RH
510(k) Number
FDA Product Code
ITX
EMDN Code
Z110402010201 Curvilinear transcutaneous two–dimensional ultrasound probes (convex–array)
GMDN Term
Surgical ultrasound imaging transducer
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Hydrogen Peroxide

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K242808)

Other devices from Canon Inc.

See all devices from Canon Inc. →

Properties

  • Serial Number

Other properties (23)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: 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