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Phipiological Synchronizer Part#205

by Brattle Instrument Corp. 510(k)

Active United States

510(k) K781681

Overview

The Phipiological Synchronizer Part#205 is a Class II X-ray system manufactured by Brattle Instrument Corp. It is a radiographic device with a stationary top table design. This device is used in radiology settings for medical imaging procedures.

The Phipiological Synchronizer Part#205 is supplied as a single unit and is not specified as single-use or reusable. It received FDA 510(k) clearance on October 17, 1978, with the decision code SESE (Substantially Equivalent). The device is regulated under product code IXQ and falls under medical specialty Radiology.

AI-generated from registry data, 22 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 NumberK781681 Date17 Oct 1978ClearedStatusActive

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 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IXQ
Device Class
Class II
Regulation
21 CFR Part 892.1980
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Brattle Instrument Corp.

Questions

  • What is the Phipiological Synchronizer Part#205 used for?

    The Phipiological Synchronizer Part#205 is a radiographic device used in medical imaging procedures within radiology settings. It features a stationary top table design that facilitates various radiological examinations.

  • Is the Phipiological Synchronizer Part#205 single-use or reusable?

    The device is supplied as a single unit, but the description does not specify whether it is intended for single-use or reusable purposes. This information should be confirmed with the manufacturer based on specific usage protocols.

  • What regulatory approvals does the Phipiological Synchronizer Part#205 have?

    The Phipiological Synchronizer Part#205 received FDA 510(k) clearance on October 17, 1978, with the decision code SESE (Substantially Equivalent). It is regulated under product code IXQ and classified under medical specialty Radiology.

  • How is the Phipiological Synchronizer Part#205 supplied?

    The device is supplied as a single unit. The packaging details, including sterility status and specific handling instructions, are not specified in the provided information and should be obtained directly from the manufacturer.