Product Code: HEM FDA class 2 21 CFR 884.2225

Imager, Ultrasonic Obstetric-Gynecologic

Obstetrics/Gynecology

The Obstetric-Gynecologic Ultrasonic Imager is a diagnostic imaging device that uses ultrasound waves to visualize structures within the female reproductive system, including the uterus, ovaries, and fetus, for diagnostic purposes. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HEM, regulated under 21 CFR 884.2225, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code HEM in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: HEM
Device Class: FDA class 2
Regulation Number: 884.2225
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 30 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K951393	ABACUS OB ULTRASOUNG COMPUTER SOFTWARE	May 01, 1995	Substantially Equivalent	Solomon Technology Labs
K942490	BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND	Feb 15, 1995	Substantially Equivalent	Medical Soft, Inc.
K910426	SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT	Jun 06, 1991	Substantially Equivalent	Shimadzu Medical Systems
K905000	ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER	Jan 31, 1991	Substantially Equivalent	Corometrics Medical Systems, Inc.
K900505	SONOACE 88 PORTABLE ULTRASOUND SCANNER	Aug 10, 1990	Substantially Equivalent	Medison Co., Ltd.
K900271	MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK	Apr 19, 1990	Substantially Equivalent	Digisonics, Inc.
K890637	EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE	Jun 12, 1989	Substantially Equivalent	Elscint, Inc.
K881329	FETAL DOPPLER FOR ULTRAMARK 4 AND 8	Apr 14, 1989	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K885061	SIEMENS INTRAVAGINAL TRANSDUCER	Feb 23, 1989	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K881185	ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.	Jun 01, 1988	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K880900	SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER	Jun 01, 1988	Substantially Equivalent	Corometrics Medical Systems, Inc.
K862364	NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)	Aug 19, 1986	Substantially Equivalent for Some Indications	Swemed Laboratories, Inc.
K862627	SONORANGER TRANSVAGINAL PROBE	Aug 01, 1986	Substantially Equivalent for Some Indications	Ausonics Pty , Ltd.
K861931	645OB SECTOR/LINEAR ULTRASOUND SCANNER	Jul 31, 1986	Substantially Equivalent for Some Indications	Ge Medical Systems Information Technologies
K860233	5 MHZ INTRACAVITARY PROBE, MODEL H4222V	Jun 02, 1986	Substantially Equivalent	General Electric Co.
K853711	5.0 MHZ INTRACAVITARY SECTOR PROBE	Dec 18, 1985	Substantially Equivalent	General Electric Co.
K853407	INTRA VAGINAL TRANSDUCER	Sep 27, 1985	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K851902	MODEL U-1000 ULTRASONIC SCANNER	Sep 27, 1985	Substantially Equivalent	Fukuda Denshi USA, Inc.
K852439	FETA SCAN 1000 OBSTETRICAL IMAGER	Aug 30, 1985	Substantially Equivalent	International Biomedics, Inc.
K842261	OB ULTRASOUND LINEAR SCANNER 630	Sep 19, 1984	Substantially Equivalent	Ge Medical Systems Information Technologies
K840623	OBSTETRICAL ULTRASOUND COMPUTER	May 11, 1984	Substantially Equivalent	R & S Systems
K834088	GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING	Dec 15, 1983	Substantially Equivalent	Whs Products, Inc.
K833488	SONICOMP	Nov 28, 1983	Substantially Equivalent	Sonicaid, Inc.
K811520	GRAYLINE IMAGING SYSTEM	Jul 02, 1981	Substantially Equivalent	Sonics Research Corp.
K810305	DATASON DB ULTRASOUND IMAGING SYSTEM	Mar 13, 1981	Substantially Equivalent	General Electric Co.
K780876	ULTRASONIC IMAGER	Jun 27, 1978	Substantially Equivalent	Air-Shields, Inc.
K771816	ROCHE AXISCAN 5	Oct 19, 1977	Substantially Equivalent	Roche Medical Electronics, Inc.
K770644	ULTRASOUND B-SCANNING SYSTEM	Apr 14, 1977	Substantially Equivalent	Unirad Corp.
K761052	REAL TIME OBSTETRICAL ULTRASONIC SCANNER	Dec 16, 1976	Substantially Equivalent	Smithkline Diagnostics, Inc.
K760874	V.I. OCTOSON ULTRASONIC SYSTEM	Dec 16, 1976	Substantially Equivalent	General Electric Co.