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FDA 510(k)

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

K-Number: K113732 · 2012-05-07

ApplicantBrainlab AG
Decision Date2012-05-07
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2012-05-07 under 510(k) number K113732. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)?

IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) is a medical device that received FDA 510(k) clearance on 2012-05-07. The listed applicant is Brainlab AG. The 510(k) number is K113732.

When did IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) receive FDA 510(k) clearance?

IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) received FDA 510(k) clearance on 2012-05-07, under 510(k) number K113732.

Who is the listed applicant for IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)?

The FDA 510(k) record lists Brainlab AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)?

The FDA product code for IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) is JAK.

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Other records listing Brainlab AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutK252562Spine & Trauma Navigation InstrumentsK243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADK243142Cranial 4Pi ImmobilizationK250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RTK243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)

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Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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