Cleared Traditional

K862643 - RADIATION ONCOLOGY COMPUTER SYS TREATMENT PLANNING (FDA 510(k) Clearance)

K862643 · Pacific Physics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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

Product Code -
Device Class -