FDA product code HEM: Imager, Ultrasonic Obstetric-Gynecologic
HEM is the FDA product code for imager, ultrasonic obstetric-gynecologic. It is a Class II device, regulated under 21 CFR 884.2225 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 30 510(k) submissions under HEM, from 24 different applicants. The average 510(k) review took 92 days (median 80). FDA has posted 1 recall for HEM devices.
Classification
| Field | Value |
|---|---|
| Device name | Imager, Ultrasonic Obstetric-Gynecologic |
| Device class | Class II |
| Regulation | 21 CFR 884.2225 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HEM clearance
Top HEM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| General Electric Co. | 4 | 1986-06-02 |
| Corometrics Medical Systems, Inc. | 2 | 1991-01-31 |
| Advanced Technology Laboratories, Inc. | 2 | 1989-04-14 |
| Ge Medical Systems Information Technologies | 2 | 1986-07-31 |
| Solomon Technology Labs | 1 | 1995-05-01 |
19 more applicants have HEM clearances. See the full list in Caduvo.
Most recent HEM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K951393 | Solomon Technology Labs | ABACUS OB ULTRASOUNG COMPUTER SOFTWARE | 1995-05-01 | 35 |
| K942490 | Medical Soft, Inc. | BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND | 1995-02-15 | 266 |
| K910426 | Shimadzu Medical Systems | SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT | 1991-06-06 | 127 |
| K905000 | Corometrics Medical Systems, Inc. | ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER | 1991-01-31 | 85 |
| K900505 | Medison Co., Ltd. | SONOACE 88 PORTABLE ULTRASOUND SCANNER | 1990-08-10 | 189 |
Recalls for HEM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-05-12.
Frequently asked questions
What is FDA product code HEM?
HEM is the FDA product code for imager, ultrasonic obstetric-gynecologic. It is a Class II device, regulated under 21 CFR 884.2225 and reviewed by the Obstetrics and Gynecology panel.
What device class is HEM?
Class II, regulation 21 CFR 884.2225. Typical premarket route: 510(k).
How long does a 510(k) take for product code HEM?
Across 30 cleared submissions the average was 92 days from receipt to decision (median 80).
Which companies have the most HEM clearances?
General Electric Co. (4); Corometrics Medical Systems, Inc. (2); Advanced Technology Laboratories, Inc. (2); Ge Medical Systems Information Technologies (2); Solomon Technology Labs (1).
Have HEM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-05-12.
Next steps
- Run an FDA pathway report with predicate devices for product code HEM
- Run a recall and safety report across every HEM manufacturer
- Watch product code HEM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times