Cleared Traditional

K780876 - ULTRASONIC IMAGER

K780876 is an FDA 510(k) clearance for ULTRASONIC IMAGER, manufactured by Air-Shields, Inc.. The device is a Class 2 Radiology device with product code HEM cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K780876 · Air-Shields, Inc. · Radiology device
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Jun 1978
Decision
28d
Days
Class 2
Risk

K780876 is an FDA 510(k) clearance for the ULTRASONIC IMAGER. Classified as Imager, Ultrasonic Obstetric-gynecologic (product code HEM), Class II - Special Controls.

Submitted by Air-Shields, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 27, 1978 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2225 - the FDA radiology and imaging software oversight framework. 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 Air-Shields, Inc. devices

FDA 510(k) Submission Details - K780876

510(k) Number K780876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1978
Decision Date June 27, 1978
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEM Device Classification - Class 2, Special Controls

Product Code HEM Imager, Ultrasonic Obstetric-gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2225
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - HEM Imager, Ultrasonic Obstetric-gynecologic

All 14
Devices cleared under the same product code (HEM) and FDA review panel - the closest regulatory comparables to K780876.
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K761052 · Smithkline Diagnostics, Inc. · Dec 1976