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Pfizonic 300 Ultrasound Scanner

by Pfizer Medical Systems, Inc. 510(k)

Active United States

510(k) K802532

Overview

The Pfizonic 300 Ultrasound Scanner is a system, imaging, pulsed echo, ultrasonic medical device classified under product code IYO and reviewed by the Radiology advisory committee. It is substantially equivalent to a predicate device and received traditional 510(k) clearance from the FDA on December 18, 1980.

Manufactured by Pfizer Medical Systems, Inc., the device is identified by the 510(k) number K802532 and was submitted on October 16, 1980. It is intended for use in radiology imaging applications as defined by its classification and regulatory submission.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802532 Date18 Dec 1980ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Pfizonic 300 Ultrasound Scanner used for?

    The Pfizonic 300 Ultrasound Scanner is intended for use in radiology imaging applications as defined by its classification under product code IYO and its regulatory submission, based on its substantial equivalence to a predicate device.

  • How was the Pfizonic 300 Ultrasound Scanner cleared for market?

    The device received traditional 510(k) clearance from the FDA on December 18, 1980, under submission number K802532, after being found substantially equivalent to a legally marketed predicate device.

  • What regulatory pathway and product code apply to the Pfizonic 300 Ultrasound Scanner?

    The Pfizonic 300 Ultrasound Scanner is classified under product code IYO and was reviewed by the Radiology advisory committee (RA) as part of its traditional 510(k) submission process.