Atlas FDA

DIGISCAN 2

FDA 510(k) clearance K924459 · decided 1992-12-17

Clearance details

K-number
K924459
Device name
DIGISCAN 2
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
1992-09-02
Decision date
1992-12-17
Days to decision
106 days
Clearance type
Traditional
Product code
IXK
Device class
2
Regulation number
892.1630
Medical specialty
Radiology
Advisory committee
Radiology
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
DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA (K093640)Electron Jsco.2011-04-29
PVMED DDR 2520 DIGITAL IMAGING SYSTEM (K072766)Portavision Medical2007-12-11
RADIOTHERAPY SOLUTION BASED ON CR (K042779)Agfa Corp.2004-10-21
PORT CASSETTE (K032654)Orex Computed Radiography, Ltd.2003-10-09
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 (K003689)Canon USA, Inc.2002-01-02
AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO (K000159)Agfa Corp.2000-02-16
FUJI FCR IMAGE PROCESSING UNIT IP-U515 (K942561)Fujifilm Medical System U.S.A., Inc.1994-12-23
DIGORA (K934949)Orion Corporation Soredex1994-02-10
FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS (K931002)Fujifilm Medical System U.S.A., Inc.1993-06-08
FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE (K923990)Fujifilm Medical System U.S.A., Inc.1992-12-17
FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE (K924012)Fujifilm Medical System U.S.A., Inc.1992-10-16
XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM (K853459)Xerox Medical Systems1985-10-30

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