Cleared Traditional

PFIZONIC 150 ULTRASOUND SCANNER (K802528) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K802528 · Pfizer Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1980
Decision
63d
Days
Class 2
Risk

K802528 is an FDA 510(k) clearance for the PFIZONIC 150 ULTRASOUND SCANNER. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Pfizer Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1980 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Pfizer Medical Systems, Inc. devices

Submission Details

510(k) Number K802528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1980
Decision Date December 18, 1980
Days to Decision 63 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 213
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K802528.
ARTICULATED ARM B-SCANNER
K811426 · General Electric Co. · Aug 1981
DATASON RTL II
K802695 · General Electric Co. · Jan 1981
SYSTEM, ECHO, PULSED ULTRASONIC DIAG.
K802708 · General Electric Co. · Jan 1981
HP MODEL 77020A ULTRASOUND SYSTEM
K801954 · Hewlett-Packard Co. · Dec 1980
DATASON DB SYSTEM
K801986 · General Electric Co. · Nov 1980
MINIVISOR TERMINAL
K802263 · Organon Teknika Corp. · Oct 1980