Atlas FDA

HEM

30 FDA 510(k) clearances · Product code

81 daysmedian time to decision
189 days90th percentile
30clearances measured

FDA profile

Official device name
Imager, Ultrasonic Obstetric-Gynecologic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2225
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
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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
SONORANGER TRANSVAGINAL PROBE (K862627)Ausonics Pty , Ltd.1986-08-01
645OB SECTOR/LINEAR ULTRASOUND SCANNER (K861931)Ge Medical Systems Information Technologies1986-07-31
5 MHZ INTRACAVITARY PROBE, MODEL H4222V (K860233)General Electric Co.1986-06-02
5.0 MHZ INTRACAVITARY SECTOR PROBE (K853711)General Electric Co.1985-12-18
MODEL U-1000 ULTRASONIC SCANNER (K851902)Fukuda Denshi USA, Inc.1985-09-27
INTRA VAGINAL TRANSDUCER (K853407)Advanced Technology Laboratories, Inc.1985-09-27
FETA SCAN 1000 OBSTETRICAL IMAGER (K852439)International Biomedics, Inc.1985-08-30
OB ULTRASOUND LINEAR SCANNER 630 (K842261)Ge Medical Systems Information Technologies1984-09-19
OBSTETRICAL ULTRASOUND COMPUTER (K840623)R & S Systems1984-05-11
GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING (K834088)Whs Products, Inc.1983-12-15
SONICOMP (K833488)Sonicaid, Inc.1983-11-28
GRAYLINE IMAGING SYSTEM (K811520)Sonics Research Corp.1981-07-02
DATASON DB ULTRASOUND IMAGING SYSTEM (K810305)General Electric Co.1981-03-13
ULTRASONIC IMAGER (K780876)Air-Shields, Inc.1978-06-27
ROCHE AXISCAN 5 (K771816)Roche Medical Electronics, Inc.1977-10-19
ULTRASOUND B-SCANNING SYSTEM (K770644)Unirad Corp.1977-04-14
V.I. OCTOSON ULTRASONIC SYSTEM (K760874)General Electric Co.1976-12-16
REAL TIME OBSTETRICAL ULTRASONIC SCANNER (K761052)Smithkline Diagnostics, Inc.1976-12-16

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