Cleared Traditional

K092424 - P-ART, MODEL 001
(FDA 510(k) Clearance)

K092424 · P-Cure, Ltd. · Radiology

Mar 2010

Decision

210d

Days

Class 2

Risk

K092424 is an FDA 510(k) clearance for the P-ART, MODEL 001. This device is classified as a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE).

Submitted by P-Cure, Ltd. (Netanya, Hasharon, IL). The FDA issued a Cleared decision on March 5, 2010, 210 days after receiving the submission on August 7, 2009.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number	K092424 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 2009
Decision Date	March 05, 2010
Days to Decision	210 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement