IYHClass II

Generator, Dermatological (grenz Ray), Therapeutic X-ray

Radiology · 21 CFR 892.5900

MDR events0All time

Recalls1All time

Registered firms1Currently listed

510(k) clearances1All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Brainlab AG
TerminatedMay 6, 2015
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery
ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees.
Z-1582-2015 · View FDA record ↗

Registered firms

1 firms currently registered for this product code

X-cel X-ray Corp.
Crystal Lake, IL, US

510(k) clearances

1 clearances for this product code

X-Cel X-Ray Corp.May 14, 1987
K871116 · X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R