IQQA Guide

510(k) Number

K151414 ↗

FDA product code

JAK

Device class

Class II

Regulation

21 CFR Part 892.1750

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

• SCAN BAND by Cook, Inc.
• HEAD-SPINE STABILIZER HSS-1 by Imaging Accessories, Inc.
• ADVANCE VESSEL ANALYSIS II by GE Healthcare
• VIATRONIC V3D CALCIUM SCORING by Viatronix, Inc.
• PRIMELUNG by Accuimage Diagnostics Corp.
• Enhanced Boundary for PCCT by GE MEDICAL SYSTEMS, INC.
• syngo.CT Dual Energy by SIEMENS MEDICAL SOLUTIONS USA, INC.
• SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO by SIEMENS MEDICAL SOLUTIONS USA, INC.
• HITACHI Supria Whole-body X-ray CT System Phase 3 by Hitachi Medical Systems America, Inc.
• OnSight 3D Extremity System by CARESTREAM HEALTH, INC.

• EDDA TECHNOLOGY IQQA-Liver Multimodality

  Class II

  FDA 510(k) K131498 Active Cleared 25 Jul 2013 GUDID on market

• EDDA TECHNOLOGY IQQA-Chest

  Class II

  FDA 510(k) K042408 Active Cleared 8 Oct 2004 GUDID on market

• EDDA TECHNOLOGY IQQA-Liver

  Class II

  FDA 510(k) K061696 Active Cleared 13 Nov 2006 GUDID on market

• EDDA TECHNOLOGY IQQA-Guide

  Class II

  FDA 510(k) K151414 Active Cleared 20 Nov 2015 GUDID on market

See all devices from EDDA Technology, Inc. →