Atlas FDA

SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS

FDA 510(k) clearance K002105 · decided 2000-12-05

Clearance details

K-number
K002105
Device name
SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
2000-07-12
Decision date
2000-12-05
Days to decision
146 days
Clearance type
Traditional
Product code
MLD
Device class
2
Regulation number
870.1025
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Danvers, MA, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 (K982104)Medical Data Electronics1998-11-25
SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS (K974492)Siemens Medical Solutions USA, Inc.1998-02-26
ACUITY CENTRAL STATION (K972121)Protocol Systems, Inc.1997-11-07
AS/3 ESTPR MODULE (K953175)Datex Division Instrumentarium Corp.1997-02-06
EAGLE 3000/3100 PATIENT MONITOR (K960272)Marquette Electronics, Inc.1996-10-02
HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24 (K960934)Hewlett-Packard Co.1996-06-14
OMNI-TRAC MODIFICATION (K935020)Invivo Research, Inc.1995-04-26

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008)Siemens Medical Solutions USA, Inc.2024-09-23
MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007)Siemens Medical Solutions USA, Inc.2020-08-21
MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006)Siemens Medical Solutions USA, Inc.2019-12-10
Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005)Siemens Medical Solutions USA, Inc.2017-09-29
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003)Siemens Medical Solutions USA, Inc.2017-03-23
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001)Siemens Medical Solutions USA, Inc.2016-05-12
MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002)Siemens Medical Solutions USA, Inc.2016-01-13
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011)Siemens Medical Solutions USA, Inc.2015-04-21