Cleared Traditional

K851301 - TARGET CAT#B7850AA & B7850AB & B7850B

K851301 is an FDA 510(k) clearance for TARGET CAT#B7850AA & B7850AB & B7850B, manufactured by General Electric Co.. The device is a Class 2 Radiology device with product code LHN cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K851301 · General Electric Co. · Radiology device
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Sep 1985
Decision
172d
Days
Class 2
Risk

K851301 is an FDA 510(k) clearance for the TARGET CAT#B7850AA & B7850AB & B7850B. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on September 20, 1985 after a review of 172 days - an extended review cycle.

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. Standard predicate reliance. 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 General Electric Co. devices

FDA 510(k) Submission Details - K851301

510(k) Number K851301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1985
Decision Date September 20, 1985
Days to Decision 172 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 107d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHN Device Classification - Class 2, Special Controls

Product Code LHN System, Radiation Therapy, Charged-particle, 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.