Cleared Traditional

K862643 - RADIATION ONCOLOGY COMPUTER SYS TREATMENT PLANNING

K862643 · Pacific Physics, Inc. · Radiology device
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Mar 1987
Decision
241d
Days
-
Risk

K862643 is an FDA 510(k) clearance for the RADIATION ONCOLOGY COMPUTER SYS TREATMENT PLANNING.

Submitted by Pacific Physics, Inc. (Encinitas, US). The FDA issued a Cleared decision on March 9, 1987 after a review of 241 days - an extended review cycle.

This device falls under the Radiology FDA review panel. 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 Pacific Physics, Inc. devices

FDA 510(k) Submission Details - K862643

510(k) Number K862643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1986
Decision Date March 09, 1987
Days to Decision 241 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 107d · This submission: 241d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -