Atlas FDA

SONOLINE SX ULTRASOUND SCANNER

FDA 510(k) clearance K852739 · decided 1986-03-10

Clearance details

K-number
K852739
Device name
SONOLINE SX ULTRASOUND SCANNER
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
1985-06-27
Decision date
1986-03-10
Days to decision
256 days
Clearance type
Traditional
Product code
DXK
Device class
2
Regulation number
870.2330
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Iselin, NJ, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter (K181042)Boston Scientific Corporation2018-05-17
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) (K160173)Boston Scientific Corporation2016-02-26
IN-VISION IMAGING SYSTEM (K031148)Jomed, Inc.2003-05-28
9750 ATHENA ETHERNET OPTION (K934887)S & W Medico Teknik A/S1994-01-14
ACCESSORY TO GENESIS III (GCFM) (K913209)Biosound, Inc.1992-05-15
CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 (K911384)Endosonics Corp.1991-06-25
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST (K904832)Hewlett-Packard Co.1991-04-22
VISTA VIEWING STATION (K904975)Prism Imaging, Inc.1991-02-25
SOFTWARE PROGRAM USED W/PRISM PRODUCTS (K904978)Prism Imaging, Inc.1991-02-25
CINE'VIEW - STRESS ECHO & IMAGE REVIEW (K904976)Prism Imaging, Inc.1991-02-25
CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (K904977)Prism Imaging, Inc.1991-02-25
PATIENT CARE MANAGEMENT SYSTEM MODIFICATION (K910029)Spacelabs, Inc.1991-01-31

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