Cleared Traditional

K934657 - BRAINLAB LINAC HARDWARE (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934657 · Brainlab Med. Computersysteme GmbH · Radiology device
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Jul 1994
Decision
304d
Days
Class 2
Risk

K934657 is an FDA 510(k) clearance for the BRAINLAB LINAC HARDWARE. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Brainlab Med. Computersysteme GmbH (Troy, US). The FDA issued a Cleared decision on July 22, 1994 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Brainlab Med. Computersysteme GmbH devices

Submission Details

510(k) Number K934657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1993
Decision Date July 22, 1994
Days to Decision 304 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 107d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

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