Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart C — Obstetrical and Gynecological Monitoring Devices](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices) → [21 CFR 884.2225](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2225) → HEM — Imager, Ultrasonic Obstetric-Gynecologic # HEM · Imager, Ultrasonic Obstetric-Gynecologic _Obstetrics/Gynecology · 21 CFR 884.2225 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM ## Overview - **Product Code:** HEM - **Device Name:** Imager, Ultrasonic Obstetric-Gynecologic - **Regulation:** [21 CFR 884.2225](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2225) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) - **3rd-party reviewable:** yes ## Identification An obstetric-gynecologic ultrasonic imager is a device designed to transmit and receive ultrasonic energy into and from a female patient by pulsed echoscopy. This device is used to provide a visual representation of some physiological or artificial structure, or of a fetus, for diagnostic purposes during a limited period of time. This generic type of device may include the following: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, coupling gel, and component parts. This generic type of device does not include devices used to monitor the changes in some physiological condition over long periods of time. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 30) Showing 20 most recent of 30 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K951393](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K951393.md) | ABACUS OB ULTRASOUNG COMPUTER SOFTWARE | Solomon Technology Labs | May 1, 1995 | SESE | | [K942490](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K942490.md) | BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND | Medical Soft, Inc. | Feb 15, 1995 | SESE | | [K910426](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K910426.md) | SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT | Shimadzu Medical Systems | Jun 6, 1991 | SESE | | [K905000](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K905000.md) | ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER | Corometrics Medical Systems, Inc. | Jan 31, 1991 | SESE | | [K900505](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K900505.md) | SONOACE 88 PORTABLE ULTRASOUND SCANNER | Medison Co., Ltd. | Aug 10, 1990 | SESE | | [K900271](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K900271.md) | MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK | Digisonics, Inc. | Apr 19, 1990 | SESE | | [K890637](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K890637.md) | EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE | Elscint, Inc. | Jun 12, 1989 | SESE | | [K881329](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K881329.md) | FETAL DOPPLER FOR ULTRAMARK 4 AND 8 | Advanced Technology Laboratories, Inc. | Apr 14, 1989 | SESE | | [K885061](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K885061.md) | SIEMENS INTRAVAGINAL TRANSDUCER | Siemens Medical Solutions USA, Inc. | Feb 23, 1989 | SESE | | [K881185](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K881185.md) | ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA. | Philips Medical Systems (Cleveland), Inc. | Jun 1, 1988 | SESE | | [K880900](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K880900.md) | SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER | Corometrics Medical Systems, Inc. | Jun 1, 1988 | SESE | | [K862364](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K862364.md) | NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) | Swemed Laboratories, Inc. | Aug 19, 1986 | SN | | [K862627](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K862627.md) | SONORANGER TRANSVAGINAL PROBE | Ausonics Pty , Ltd. | Aug 1, 1986 | SN | | [K861931](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K861931.md) | 645OB SECTOR/LINEAR ULTRASOUND SCANNER | Ge Medical Systems Information Technologies | Jul 31, 1986 | SN | | [K860233](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K860233.md) | 5 MHZ INTRACAVITARY PROBE, MODEL H4222V | General Electric Co. | Jun 2, 1986 | SESE | | [K853711](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K853711.md) | 5.0 MHZ INTRACAVITARY SECTOR PROBE | General Electric Co. | Dec 18, 1985 | SESE | | [K853407](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K853407.md) | INTRA VAGINAL TRANSDUCER | Advanced Technology Laboratories, Inc. | Sep 27, 1985 | SESE | | [K851902](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K851902.md) | MODEL U-1000 ULTRASONIC SCANNER | Fukuda Denshi USA, Inc. | Sep 27, 1985 | SESE | | [K852439](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K852439.md) | FETA SCAN 1000 OBSTETRICAL IMAGER | International Biomedics, Inc. | Aug 30, 1985 | SESE | | [K842261](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM/K842261.md) | OB ULTRASOUND LINEAR SCANNER 630 | Ge Medical Systems Information Technologies | Sep 19, 1984 | SESE | ## Top Applicants - General Electric Co. — 4 clearances - Advanced Technology Laboratories, Inc. — 2 clearances - Corometrics Medical Systems, Inc. — 2 clearances - Ge Medical Systems Information Technologies — 2 clearances - Air-Shields, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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