# K993037: LCV+ Version 2

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Feb 14, 2000 after 158 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890348 (1989). 3 ancestors in all.
330 later devices descend from it; 6 cite it directly.
10 of 334 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890348: LC, Cardiac Positioner #B5078A, General Electric Co. (1989) Summary page 1.
- K926258: DLX, GE Medical Systems (1993) Summary page 1.
- K945459: DLX, General Electric Co. (1995) Summary page 1.

## Most influential descendants
- K021021: Modular Angiography System Axiom Artis (2002), 218 descendants of its own
- K020055: Philips Integris Allura 9 with FD Option (2002), 124 descendants of its own
- K022899: Philips Integris Allura Flat Detector Release 1.0 (2002), 114 descendants of its own
- K031333: Philips Integris Allura Flat Detector Release 1.2 (2003), 113 descendants of its own
- K023178: Innova 4100 (2002), 97 descendants of its own

## Recalls of this device
- 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
- Aug 6, 2009 · Not classified · Z-0393-2011: GE Healthcare has become aware of a potential video splitter failure with certain Innova 2000 and 4100 X-ray systems that may impact patient safety. A potential video splitter failure inside the GE eq
- Aug 6, 2009 · Not classified · Z-0392-2011: GE Healthcare has become aware of a potential video splitter failure with certain Innova 2000 and 4100 X-ray systems that may impact patient safety. A potential video splitter failure inside the GE eq
- 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.

## Indications for use
The LCV+ Version 2 is indicated for use in generating fluoroscopic images of human anatomy for cardiology diagnostic/interventional procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology.

Source page: https://510kreport.com/device/K993037
Methodology: https://510kreport.com/methodology