The following data is part of a premarket notification filed by Quantum Medical Systems, Inc. with the FDA for Quantum 2000 Angiodynograph Ultrasound System.
| Device ID | K904019 |
| 510k Number | K904019 |
| Device Name: | QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | QUANTUM MEDICAL SYSTEMS, INC. 1040 12TH AVE. Issaquah, WA 98027 |
| Contact | Daine L Graham |
| Correspondent | Daine L Graham QUANTUM MEDICAL SYSTEMS, INC. 1040 12TH AVE. Issaquah, WA 98027 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-30 |
| Decision Date | 1991-03-22 |