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C-beam 1.0

by Pulmera, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860016243804 UDI-DI Date10 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
C-beam
Generic Name
Stationary general-purpose fluoroscopic x-ray system, digital
Model / Reference
1.0
Primary DI / UDI-DI
00860016243804
510(k) Number
FDA Product Code
OWB, JAK
GMDN Term
Stationary general-purpose fluoroscopic x-ray system, digital
Device Class
Class II
Regulation Number
892.1650, 892.1750
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Other devices from Pulmera, Inc.

  • C-beam

    Class II

Properties

  • Contains Latex
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No