510(k) K990423

PHILIPS NICOL COLLIMATOR FAMILY by Philips Medical Systems, Inc. — Product Code IZW

K990423 is an FDA 510(k) premarket notification submitted by Philips Medical Systems, Inc. for the device "PHILIPS NICOL COLLIMATOR FAMILY". The FDA issued a decision of Substantially Equivalent on March 15, 1999. The device falls under product code IZW (Collimator, Automatic, Radiographic), a Class II device regulated under 21 CFR 892.1610. Philips Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1999
Date Received
February 11, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collimator, Automatic, Radiographic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type