Atlas FDA

SONICOMP

FDA 510(k) clearance K833488 · decided 1983-11-28

Clearance details

K-number
K833488
Device name
SONICOMP
Applicant
Sonicaid, Inc.
Decision
Substantially Equivalent
Date received
1983-10-07
Decision date
1983-11-28
Days to decision
52 days
Clearance type
Traditional
Product code
HEM
Device class
2
Regulation number
884.2225
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Sonicaid

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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.