Atlas FDA

SIEMENS INTRAVAGINAL TRANSDUCER

FDA 510(k) clearance K881405 · decided 1988-08-02

Clearance details

K-number
K881405
Device name
SIEMENS INTRAVAGINAL TRANSDUCER
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
1988-04-04
Decision date
1988-08-02
Days to decision
120 days
Clearance type
Traditional
Product code
HGL
Device class
2
Regulation number
884.2960
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
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
ULTRASOUND TRANSDUCER, MODEL US917 (K952031)Advanced Medical Systems, Inc.1995-07-18
ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION (K923335)Advanced Medical Systems, Inc.1994-07-22
OP3/VP4 (K924516)Huntleigh Technology, Inc.1993-06-28
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM (K903348)Advanced Technology Laboratories, Inc.1990-10-22
EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE (K900966)Hitachi Medical Corp. of America1990-09-12
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (K903316)Ge Medical Systems Information Technologies1990-08-22
MER MULTIPLANE VAGINAL PROBE (MVP) (K901142)Medical Equipment Resources1990-08-22
TRANSVAGINAL TRANSDUCER ASSEMBLY (K900838)Pie Medical Equipment B.V.1990-05-23
ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM (K895449)Ge Medical Systems Information Technologies1990-03-05
MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER (K881263)Multigon Industries, Inc.1990-01-05
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER (K895647)Advanced Technology Laboratories, Inc.1989-12-18
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER (K895123)Advanced Technology Laboratories, Inc.1989-11-13

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