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Corridor4DM v2013

by Invia

Corridor4DM v2013, a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Invia, was cleared under FDA 510(k) K101279 on 4 Aug 2010 and listed in FDA GUDID on 4 Aug 2016 (UDI-DI 00864974000202); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K101279

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 Number00864974000202 UDI-DI Date4 Aug 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK101279 Date4 Aug 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K101279 decided 4 Aug 2010 Active
  • FDA GUDID UDI-DI 00864974000202 listed 4 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K101279
  2. Listed FDA GUDID 00864974000202

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Corridor4DM
Generic name
Radiology DICOM image processing application software
Model / reference
v2013
Primary DI / UDI-DI
00864974000202
510(k) Number
FDA product code
LLZ
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K101279)

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Invia

  • 4DM

    Class II

  • Corridor4DM v2016

    Class II

  • Corridor4DM v2017

    Class II

  • Corridor4DM C4DM10

    Class II

See all devices from Invia →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)