Device Atlas

Polyscan Digital Scanner

Q: What is the product code of K944684?

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

FDA 510(k) K944684 · Mse Medizintechnik GmbH & Co. KG

Substantially Equivalent

510(k) numberK944684

Submission

Device name: Polyscan Digital Scanner
Applicant: Mse Medizintechnik GmbH & Co. KG
Rodemark, DE
Received: September 22, 1994
Decision date: May 15, 1995
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

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)	Device	Applicant	Decision
K895799	Rectilinear Scanner Model #187-270IYW · Traditional	Atomic Products Corp.	02/01/1990SE
K882453	Polyscan Digital ScannerIYW · Traditional	Medical and Scientific Enterprises, Inc.	11/23/1988SE
K780395	Imager, Body Section, RadionuclideIYW · Traditional	Union Carbide Corp.	03/31/1978SE

Questions and answers

When was Polyscan Digital Scanner cleared by the FDA?

Polyscan Digital Scanner (K944684) received a 510(k) decision of Substantially Equivalent on May 15, 1995, 235 days after the submission was received.

What is the product code of K944684?

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