CORRIDOR4DM V2010 Model: V2010

FDA 510(k) K101279 · Invia

Substantially Equivalent

510(k) numberK101279

Submission

Device name
CORRIDOR4DM V2010 Model: V2010
Applicant
Invia
Ashland, MA, US
Received
May 6, 2010
Decision date
August 4, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

Other 510(k)s with product code LLZ

510(k)DeviceApplicantDecision
K2620603D-RD-SLLZ · Traditional Radiopharmaceutical Imaging & Dosimetry, LLC09/04/2026SE
K261500KBA3D (v2.4.0)LLZ · Traditional S.M.A.I.O08/17/2026SE
K262449AdvaViewLLZ · Special Advahealth Solutions, LLC08/14/2026SE
K261916NeuroQuant PETLLZ · Traditional Cortechs Labs, Inc.08/12/2026SE
K260936RadioViewAILLZ · Traditional Neurocareai, Inc. (Dba Savelife.Ai)07/31/2026SE
K260588Cleerly LABSLLZ · Traditional Cleerly, Inc.07/29/2026SE
K262462TheraSphere 360™ Y-90 Management PlatformLLZ · Special Boston Scientific Corporation07/24/2026SE
K262143ImageGrid StreamVueLLZ · Traditional Candelis, Inc.07/23/2026SE
K260500ResolutionMDLLZ · Traditional ResolutionMD, Inc.07/21/2026SE
K262120Avara ViewerLLZ · Traditional Avara Software07/10/2026SE

More from Avara Software

510(k)DeviceDecision
K2608794DMQIH · Traditional 09/10/2026SE
K080575CORRIDOR4DMKPS · Traditional 05/13/2008SE

Questions and answers

When was CORRIDOR4DM V2010 Model: V2010 cleared by the FDA?

CORRIDOR4DM V2010 Model: V2010 (K101279) received a 510(k) decision of Substantially Equivalent on August 4, 2010, 90 days after the submission was received.

What is the product code of K101279?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.