Polyscan Digital Scanner

FDA 510(k) K882453 · Medical and Scientific Enterprises, Inc.

Substantially Equivalent

510(k) numberK882453

Submission

Device name
Polyscan Digital Scanner
Applicant
Medical and Scientific Enterprises, Inc.
Sudbury, MA, US
Received
June 14, 1988
Decision date
November 23, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IYW – Scanner, Rectilinear, Nuclear
Device class
Class I (low risk)
Regulation
21 CFR 892.1300
Specialty
Radiology

Other 510(k)s with product code IYW

510(k)DeviceApplicantDecision
K944684Polyscan Digital ScannerIYW · Traditional Mse Medizintechnik GmbH & Co. KG05/15/1995SE
K895799Rectilinear Scanner Model #187-270IYW · Traditional Atomic Products Corp.02/01/1990SE
K780395Imager, Body Section, RadionuclideIYW · Traditional Union Carbide Corp.03/31/1978SE

More from Union Carbide Corp.

510(k)DeviceDecision
K933131Bistat 70/70-I Electrosurgical UnitGEI · Traditional 02/15/1994SE
K913881Endostat Electrosurgical UnitKNS · Traditional 11/01/1991SE
K895855PhoenixKNS · Traditional 01/22/1990SE
K861233Dual Photon Bone DensitometerKGI · Traditional 03/03/1987SE

Questions and answers

When was Polyscan Digital Scanner cleared by the FDA?

Polyscan Digital Scanner (K882453) received a 510(k) decision of Substantially Equivalent on November 23, 1988, 162 days after the submission was received.

What is the product code of K882453?

The FDA product code is IYW – Scanner, Rectilinear, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1300.