Cleared Traditional

K827035 - OCULAR BIOMETER 4000 (FDA 510(k) Clearance)

K827035 · Radionics Medical, Inc. · Radiology device
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Jul 1982
Decision
90d
Days
-
Risk

K827035 is an FDA 510(k) clearance for the OCULAR BIOMETER 4000.

Submitted by Radionics Medical, Inc. (Ontario L3r 1g2, CA). The FDA issued a Cleared decision on July 22, 1982 after a review of 90 days - within the typical 510(k) review window.

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 Radionics Medical, Inc. devices

Submission Details

510(k) Number K827035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1982
Decision Date July 22, 1982
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -