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XENOVIEW 3.0T Chest Coil Rev B

by Polarean, 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 Number00850045949051 UDI-DI Date23 Sep 2025ListedStatusListed 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  • Withdrawn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
XENOVIEW 3.0T Chest Coil
Generic Name
MRI system coil, radio-frequency
Model / Ref / Catalog
Rev B, 44315-03
Primary DI / UDI-DI
00850045949051
510(k) Number
FDA Product Code
MOS
GMDN Term
MRI system coil, radio-frequency
Device Class
Class II
Regulation Number
892.1000
GUDID distribution status
In Commercial Distribution

Other devices from Polarean, Inc.

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Properties

  • Prescription Use
  • Combination Product
  • Lot / Batch Number
  • Serial Number

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No