Atlas FDA

SIENET TELERADIOLOGY PRODUCT LINE

FDA 510(k) clearance K955394 · decided 1996-02-21

Clearance details

K-number
K955394
Device name
SIENET TELERADIOLOGY PRODUCT LINE
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
1995-11-24
Decision date
1996-02-21
Days to decision
89 days
Clearance type
Traditional
Product code
LMC
Device class
2
Regulation number
892.2040
Medical specialty
Radiology
Advisory committee
Radiology
Location
Iselin, NJ, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Siemens Medical Solutions USA

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD (K141454)Sony Electronics, Inc.2014-06-26
SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD (K141346)Sony Electronics, Inc.2014-06-26
DRYVIEW CHROMA IMAGING SYSTEM (K111566)Carestream Health, Inc.2011-10-06
CYPHER DICOM PRINT SOLUTION (K092280)Virtual Imaging, Inc.2009-10-16
CARESTREAM DRYVIEW 5850 LASER IMAGER (K090469)Carestream Health, Inc.2009-05-22
SONY UP-DF750 DIGITAL FILM IMAGER (K083522)Sony Electronics, Inc.2009-01-09
LASER IMAGER DRYPRO MODEL 873 (K081637)Konica Minolta Medical & Graphic, Inc.2008-07-01
DRYSTAR AXYS, MODEL EYZ4E (K072680)Agfa Healthcare Corporation2007-10-25
DRY LASER IMAGER, DRYPRO MODEL 832 (K061999)Konica Minolta Medical & Graphic, Inc.2006-08-15
DIGITAL PRINTER P6000D SERIES, MODEL P6000DU (K061302)Mitsubishi Electric Corporation Kyoto Works2006-06-23
CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER (K060440)Codonics, Inc.2006-03-16
DRYSTAR MODEL 5500 (K052251)Agfa Corporation2005-08-31

Recalls involving this device

RecordFirmDate
Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, proc recall (Z-1354-2015)Siemens Medical Solutions USA, Inc2015-03-30
Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended t recall (Z-1027-2015)Siemens Medical Solutions USA, Inc2015-01-28

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