Atlas FDA

ULTRASONIC PULSED DOPPLER IMAGING SYSTEM

FDA 510(k) clearance K903348 · decided 1990-10-22

Clearance details

K-number
K903348
Device name
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
Applicant
Advanced Technology Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1990-07-26
Decision date
1990-10-22
Days to decision
88 days
Clearance type
Traditional
Product code
HGL
Device class
2
Regulation number
884.2960
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Bothell, WA, 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
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
HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER (K895026)Hewlett-Packard Co.1989-11-06

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD (P940005/S002)Advanced Technology Laboratories, Inc.1998-07-21
HDI 3000 ULTRASOUND SYSTEM (P940005/S001)Advanced Technology Laboratories, Inc.1996-12-23
ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM (P940005)Advanced Technology Laboratories, Inc.1996-04-11