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Faxitron CoreVision 5x10

by Faxitron Bioptics, LLC

Faxitron CoreVision 5x10 is a stationary specimen x-ray system (FDA Class II; FDA product code MWP, Cabinet,X-Ray System) made by Faxitron Bioptics, LLC, cleared under FDA 510(k) K082432 on 21 Nov 2008 and listed in FDA GUDID since 17 Aug 2016 (UDI-DI 00857069006005), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K082432

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857069006005 UDI-DI Date17 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082432 Date21 Nov 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082432 decided 21 Nov 2008 Active
  • FDA GUDID UDI-DI 00857069006005 listed 17 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082432
  2. Listed FDA GUDID 00857069006005

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Faxitron
Generic name
Stationary specimen x-ray system, digital
Model / reference
CoreVision 5x10
Primary DI / UDI-DI
00857069006005
510(k) Number
FDA product code
MWP
GMDN term
Stationary specimen x-ray system, digital
Device class
Class II
Regulation number
892.1680
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stationary specimen x-ray system, digital

Cleared under the same submission (K082432)

Similar devices

Other devices filed under FDA product code MWP (Cabinet,X-Ray System).

Other devices from Faxitron Bioptics, LLC

See all devices from Faxitron Bioptics, LLC →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)