Atlas FDA

5.0 MHZ INTRACAVITARY SECTOR PROBE

FDA 510(k) clearance K853711 · decided 1985-12-18

Clearance details

K-number
K853711
Device name
5.0 MHZ INTRACAVITARY SECTOR PROBE
Applicant
General Electric Co.
Decision
Substantially Equivalent
Date received
1985-09-05
Decision date
1985-12-18
Days to decision
104 days
Clearance type
Traditional
Product code
HEM
Device class
2
Regulation number
884.2225
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Milwaukee, WI, 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
ABACUS OB ULTRASOUNG COMPUTER SOFTWARE (K951393)Solomon Technology Labs1995-05-01
BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND (K942490)Medical Soft, Inc.1995-02-15
SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT (K910426)Shimadzu Medical Systems1991-06-06
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (K905000)Corometrics Medical Systems, Inc.1991-01-31
SONOACE 88 PORTABLE ULTRASOUND SCANNER (K900505)Medison Co., Ltd.1990-08-10
MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK (K900271)Digisonics, Inc.1990-04-19
EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE (K890637)Elscint, Inc.1989-06-12
FETAL DOPPLER FOR ULTRAMARK 4 AND 8 (K881329)Advanced Technology Laboratories, Inc.1989-04-14
SIEMENS INTRAVAGINAL TRANSDUCER (K885061)Siemens Medical Solutions USA, Inc.1989-02-23
SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER (K880900)Corometrics Medical Systems, Inc.1988-06-01
ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA. (K881185)Philips Medical Systems (Cleveland), Inc.1988-06-01
NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) (K862364)Swemed Laboratories, Inc.1986-08-19

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