IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO

FDA 510(k) clearance K022292 · decided 2002-09-12

Clearance details

K-number: K022292
Device name: IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO
Applicant: Agfa Corp.
Decision: Substantially Equivalent
Date received: 2002-07-15
Decision date: 2002-09-12
Days to decision: 59 days
Clearance type: Traditional
Product code: LLZ
Device class: 2
Regulation number: 892.2050
Medical specialty: Radiology
Advisory committee: Radiology
Location: Brevard, NC, US
Third-party review: No
Expedited review: No

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Record	Firm	Date
IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatic recall (Z-2246-2011)	AGFA Corp.	2011-05-24
Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems ( recall (Z-1887-2009)	AGFA Corp.	2009-09-08
IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Ca recall (Z-0945-2009)	AGFA Corp.	2009-02-03
IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture Archiv recall (Z-1243-2008)	AGFA Corp.	2008-09-11
WEB1000 Versions 3.1, 4.1 and 5.1, Picture Archiving and Communications systems (PACs), us recall (Z-1244-2008)	AGFA Corp.	2008-09-11
Impax 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2. recall (Z-2180-2008)	AGFA Corp.	2008-09-04
Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integ recall (Z-1307-2008)	AGFA Corp.	2008-07-02
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis) recall (Z-0033-2007)	AGFA Corp.	2006-10-12
IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processi recall (Z-1256-06)	AGFA Corp.	2006-07-27