Doppler Phantom Flow Control Sys
FDA 510(k) K834481 · Radiation Measurements, Inc.
510(k) numberK834481
Submission
- Device name
- Doppler Phantom Flow Control Sys
- Applicant
- Radiation Measurements, Inc.
Mchenry, IL, US - Received
- December 15, 1983
- Decision date
- January 25, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IXF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K865100 | Tissue-Equivalent Breast SimulatorIXF · Traditional | Computerized Imaging Reference Systems, Inc. | 01/12/1987SE |
| K851812 | Digital Subtraction Antiography Phantom 76-700/711IXF · Traditional | Victoreen, Inc. | 06/05/1985SE |
| K834482 | Tissue Mimicking Ultrasound PhantomsIXF · Traditional | Radiation Measurements, Inc. | 01/25/1984SE |
| K810254 | 1.5` Focal Spot Resolution PatternIXF · Traditional | Machlett Laboratories, Inc. | 02/19/1981SE |
More from Machlett Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K893216 | Rmi Ultrasound Doppler Phantom SystemGXX · Traditional | 09/05/1989SE |
| K885223 | Rmi Short Distance Alignment DeviceLNH · Traditional | 02/17/1989SE |
| K873956 | UltimeterLHO · Traditional | 10/30/1987SE |
| K873836 | Mammographic KVP Meter Model 232IZH · Traditional | 10/16/1987SE |
| K854976 | Rmi Respiratory Gating System Model 301IXO · Traditional | 05/07/1986SE |
| K834483 | Digi-XLHO · Traditional | 03/05/1984SE |
| K834607 | Electronic KVP CassetteIWN · Traditional | 02/21/1984SE |
| K834482 | Tissue Mimicking Ultrasound PhantomsIXF · Traditional | 01/25/1984SE |
| K837033 | Rotatable Half Beam Shielding Block Model 440 · Traditional | 03/09/1983SE |
| K812949 | Rmi Transilluminator, Model 292HJM · Traditional | 12/02/1981SE |
Questions and answers
When was Doppler Phantom Flow Control Sys cleared by the FDA?
Doppler Phantom Flow Control Sys (K834481) received a 510(k) decision of Substantially Equivalent on January 25, 1984, 41 days after the submission was received.
What is the product code of K834481?
The FDA product code is IXF – Test-Pattern, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1940.