# K022322: Innova and Innova 2000 S

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Oct 8, 2002 after 83 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K890348 (1989). 5 ancestors in all.
78 later devices descend from it; 3 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993037: LCV+ Version 2, Ge Medical Systems, Inc. (2000) Summary page 1.
- K945375: Advantx Lca, GE Medical Systems (1995) Summary page 1.

## Most influential descendants
- K031637: Innova 3100 (2003), 76 descendants of its own
- K050489: Innova 2100 (2005), 75 descendants of its own
- K052412: Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ (2005), 74 descendants of its own
- K060259: Digital Fluoroscopic Imaging Systems - Innova  3131 & Innova 2121 (2006), 47 descendants of its own
- K081582: Infx-8000V, Infinix-Cfi and Infinix Vfi (2008), 23 descendants of its own

## Recalls of this device
- Nov 21, 2016 · Class II · Z-0904-2017: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
- Dec 18, 2015 · Class II · Z-0763-2016: GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.
- Aug 16, 2013 · Class II · Z-0021-2014: GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Inn
- Jun 10, 2010 · Not classified · Z-2238-2010: A hardware component (potentiometer and encoder)mismatch in Innova 2000 digital fluoroscopic imaging systems may cause a Source to Image Distance (SID) failure, which will cause the imager to fail to 
- Dec 22, 2009 · Not classified · Z-0620-2010: Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potentia
- Jul 25, 2008 · Not classified · Z-2435-2008: The charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down.
- Mar 6, 2006 · Not classified · Z-0896-06: Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.

## Indications for use
The Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and interventional cardiac angiography and optionally, rotational cardiac angiography procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional cardiac angiography procedures.

Source page: https://510kreport.com/device/K022322
Methodology: https://510kreport.com/methodology