Cleared Traditional

MODEL LS 3000 LINEAR SCANNER (K827377) - FDA 510(k) Clearance

K827377 · Hitachi Medical Corp. · Radiology device
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Jul 1982
Decision
84d
Days
-
Risk

K827377 is an FDA 510(k) clearance for the MODEL LS 3000 LINEAR SCANNER.

Submitted by Hitachi Medical Corp. (Tokyo, JP). The FDA issued a Cleared decision on July 13, 1982 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K827377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1982
Decision Date July 13, 1982
Days to Decision 84 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -