IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)

System, X-ray, Tomography, Computed

BRAINLAB AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Iplan (iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan Cmf, Iplan View, Iplan Spine).

Pre-market Notification Details

• Device ID: K113732
• 510k Number: K113732
• Device Name: IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)
• Classification: System, X-ray, Tomography, Computed
• Applicant: BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622
• Contact: Alexander Schwiersch
• Correspondent: Alexander Schwiersch; BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622
• Product Code: JAK
• CFR Regulation Number: 892.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-12-19
• Decision Date: 2012-05-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056481140984	K113732	000
04056481142162	K113732	000
04056481142186	K113732	000
04056481000240	K113732	000
04056481000608	K113732	000
04056481000653	K113732	000
04056481000677	K113732	000
04056481006884	K113732	000
04056481108243	K113732	000
04056481000257	K113732	000
04056481140571	K113732	000
04056481108755	K113732	000