Atlas FDA

ARTIUS SYSTEM

FDA 510(k) clearance K771151 · decided 1977-08-04

Clearance details

K-number
K771151
Device name
ARTIUS SYSTEM
Applicant
General Electric Co.
Decision
Substantially Equivalent
Date received
1977-06-24
Decision date
1977-08-04
Days to decision
41 days
Clearance type
Traditional
Product code
HGL
Device class
2
Regulation number
884.2960
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Mchenry, IL, 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
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S017)General Electric Co.1988-07-29
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S013)General Electric Co.1988-07-15
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S016)General Electric Co.1988-06-30
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S014)General Electric Co.1988-05-05
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S015)General Electric Co.1988-05-02
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S012)General Electric Co.1987-11-25
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S011)General Electric Co.1987-06-18
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S010)General Electric Co.1987-03-30