GE Sonochrome
FDA 510(k) K915138 · GE Medical Systems
510(k) numberK915138
Submission
- Device name
- GE Sonochrome
- Applicant
- GE Medical Systems
Waukesha, WI, US - Received
- November 13, 1991
- Decision date
- October 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAA – Monitor, Fetal Doppler Ultrasound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MAA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102138 | Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerMAA · Traditional | Edan Instruments, Inc. | 10/28/2010SE |
| K090499 | Lifedop Model, L350RMAA · Traditional | Summit Doppler Systems, Inc. | 03/31/2009SE |
| K905536 | Fetal DopplerMAA · Traditional | Toshiba America Medical Systems, In.C | 04/21/1992SE |
| K904600 | L582 TransducerMAA · Traditional | Acuson Corp. | 06/24/1991SE |
| K905456 | L328 TransducerMAA · Traditional | Acuson Corp. | 05/28/1991SE |
| K904951 | S5192R TransducerMAA · Traditional | Acuson Corp. | 04/29/1991SE |
| K895909 | Sonicaid Model Vasoflo 4MAA · Traditional | Oxford Medilog, Inc. | 07/09/1990SE |
| K894992 | Quantum Qad Angiodynograph Ultrasound SystemMAA · Traditional | Quantum Medical Systems, Inc. | 02/23/1990SE |
More from Quantum Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253808 | AIR Recon DLLNH · Traditional | 08/13/2026SE |
| K253560 | Enhanced Boundary for PCCTJAK · Traditional | 06/24/2026SE |
| K253502 | Critical Care Suite with Enteric Tube Positioning AI AlgorithmQIH · Traditional | 04/14/2026SE |
| K253520 | Photonova Spectra, Photonova Spectra SelectJAK · Traditional | 03/20/2026SE |
| K253780 | SIGNA BoltLNH · Traditional | 02/06/2026SE |
| K253779 | SIGNA Sprint SelectLNH · Traditional | 02/05/2026SE |
| K252379 | AIR Recon DLLNH · Traditional | 12/23/2025SE |
| K251399 | SIGNA SprintLNH · Traditional | 09/11/2025SE |
| K250941 | Revolution VibeJAK · Traditional | 08/01/2025SE |
| K243667 | Sonic DLLNH · Traditional | 06/05/2025SE |
Questions and answers
When was GE Sonochrome cleared by the FDA?
GE Sonochrome (K915138) received a 510(k) decision of Substantially Equivalent on October 20, 1992, 342 days after the submission was received.
What is the product code of K915138?
The FDA product code is MAA – Monitor, Fetal Doppler Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 884.2660.