Cleared Traditional

K841048 - TRANSDUCER 4.OMHZ LA4011

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

FDA 510(k) Submission Details - K841048

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 107d · This submission: 319d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -