Digi-X
FDA 510(k) K834483 · Radiation Measurements, Inc.
510(k) numberK834483
Submission
- Device name
- Digi-X
- Applicant
- Radiation Measurements, Inc.
Mchenry, IL, US - Received
- December 6, 1983
- Decision date
- March 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K042733 | Standard Imaging Pipspro Qa Software SystemLHO · Traditional | Standard Imaging, Inc. | 11/15/2004SE |
| K873956 | UltimeterLHO · Traditional | Radiation Measurements, Inc. | 10/30/1987SE |
| K860260 | Multi Purpose Model 76-903LHO · Traditional | Victoreen, Inc. | 05/07/1986SE |
| K853754 | Magnetic Resonance Imaging UNIFORMITY/T1 76-901LHO · Traditional | Victoreen, Inc. | 05/07/1986SE |
| K860100 | MRI Slice Thickness & Contiguity Phantom #76-902LHO · Traditional | Victoreen, Inc. | 04/22/1986SE |
| K845007 | RFA-7 Radiation Field AnalyzerLHO · Traditional | Varian Assoc., Inc. | 07/01/1985SE |
| K844620 | BDS-3 Beam Data ScannerLHO · Traditional | Varian Assoc., Inc. | 07/01/1985SE |
More from Varian Assoc., 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 |
| K834607 | Electronic KVP CassetteIWN · Traditional | 02/21/1984SE |
| K834482 | Tissue Mimicking Ultrasound PhantomsIXF · Traditional | 01/25/1984SE |
| K834481 | Doppler Phantom Flow Control SysIXF · 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 Digi-X cleared by the FDA?
Digi-X (K834483) received a 510(k) decision of Substantially Equivalent on March 5, 1984, 90 days after the submission was received.
What is the product code of K834483?
The FDA product code is LHO – Instrument, Quality-Assurance, Radiologic, a Class I (low risk) device regulated under 21 CFR 892.1940.