Cleared Traditional

K841048 - TRANSDUCER 4.OMHZ LA4011 (FDA 510(k) Clearance)

K841048 · Philips Ultrasound, Inc. · Radiology device
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Jan 1985
Decision
319d
Days
-
Risk

K841048 is an FDA 510(k) clearance for the TRANSDUCER 4.OMHZ LA4011.

Submitted by Philips Ultrasound, Inc. (Santa Ana, US). The FDA issued a Cleared decision on January 25, 1985 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Philips Ultrasound, Inc. devices

Submission Details

510(k) Number K841048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date January 25, 1985
Days to Decision 319 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 107d · This submission: 319d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -