Cleared Traditional

K827035 - OCULAR BIOMETER 4000

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

FDA 510(k) Submission Details - K827035

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 - Class ,

Product Code -
Device Class -