PVS Model 1.0

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K102237 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Medcom GmbH →

• What is the PVS Model 1.0 used for?

  The PVS Model 1.0 is an accelerator device used in radiology. It is a Class II medical device designed for specific radiological procedures, though the exact indications are not specified in the provided data.

• How is the PVS Model 1.0 supplied?

  The PVS Model 1.0 is supplied by Medcom GmbH, located in Darmstadt, Hessen, Germany. The device is manufactured and distributed from this address, with Stefan Walter listed as the contact person.

• What is the regulatory status of the PVS Model 1.0?

  The PVS Model 1.0 has received FDA clearance under 510(k) with K-number K102237. It was determined to be substantially equivalent and received clearance on November 23, 2010. The device is regulated under product code IYE and regulation number 892.5050.

• Is the PVS Model 1.0 a single-use or reusable device?

  The provided data does not specify whether the PVS Model 1.0 is designed for single-use or multiple uses. This information would typically be found in the device's instructions for use or labeling materials.