FDA Device Intelligence
Home › VISIONFLEX PTY. LTD. › Visionflex

Visionflex

VISIONFLEX PTY. LTD. · Model VFGEISCAM1.04 · UDI-DI 09352527000775

FWB
6
510(k) clearances
177
Adverse events
2
Recalls
35
Facilities

Description

GEIS Camera (General Examination Imaging System) is a handheld device that can capture medical grade quality images and video in Full HD 1080p resolution at the touch of a button.

Recalls

DateFirmReason
2017-12-15Trumpf Medical Systems, Inc.The radiated emission from the TruVidia" Wireless Receiver is above the normative accepted limits, in which the radiated emission may interact with other devices in the operating r
2015-01-13Sony Medical SystemsTthe medical monitor has either not turned on or has lost image during clinical use.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.