Quantum Qad Angiodynograph Ultrasound System
FDA 510(k) K894992 · Quantum Medical Systems, Inc.
510(k) numberK894992
Submission
- Device name
- Quantum Qad Angiodynograph Ultrasound System
- Applicant
- Quantum Medical Systems, Inc.
Issaquah, WA, US - Received
- August 8, 1989
- Decision date
- February 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K915138 | GE SonochromeMAA · Traditional | GE Medical Systems | 10/20/1992SE |
| 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 |
More from Oxford Medilog, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K904019 | Quantum 2000 Angiodynograph Ultrasound SystemIYO · Traditional | 03/22/1991SE |
| K890998 | Qad Angiodynograph Ultrasound: Color Doppler Eval.IYN · Traditional | 05/02/1989SE |
| K860581 | QAD-1 Angiodynograph Ultrasound SystemIYO · Traditional | 02/13/1987SE |
| K853217 | QAD-1 Angio Dynograph Ultraso W/5.0 7.5 MHZ ProbesIYO · Traditional | 12/30/1985SE |
Questions and answers
When was Quantum Qad Angiodynograph Ultrasound System cleared by the FDA?
Quantum Qad Angiodynograph Ultrasound System (K894992) received a 510(k) decision of Substantially Equivalent on February 23, 1990, 199 days after the submission was received.
What is the product code of K894992?
The FDA product code is MAA – Monitor, Fetal Doppler Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 884.2660.