Cleared Traditional

K802484 - SINVISION 2001 ULTRASOUND SCANNER (FDA 510(k) Clearance)

K802484 · National Ultrasound Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1980
Decision
46d
Days
-
Risk

K802484 is an FDA 510(k) clearance for the SINVISION 2001 ULTRASOUND SCANNER.

Submitted by National Ultrasound Corp. (Mchenry, US). The FDA issued a Cleared decision on December 1, 1980 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology 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 National Ultrasound Corp. devices

Submission Details

510(k) Number K802484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1980
Decision Date December 01, 1980
Days to Decision 46 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 160d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -