Cleared Traditional

K837304 - MODELS 246 AND 210F LINEAR ARRAY ULTRASOUND SCANNER (FDA 510(k) Clearance)

K837304 · Aloka Co., Ltd. · Radiology device
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May 1983
Decision
52d
Days
-
Risk

K837304 is an FDA 510(k) clearance for the MODELS 246 AND 210F LINEAR ARRAY ULTRASOUND SCANNER.

Submitted by Aloka Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on May 9, 1983 after a review of 52 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.

View all Aloka Co., Ltd. devices

Submission Details

510(k) Number K837304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1983
Decision Date May 09, 1983
Days to Decision 52 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 107d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -