Standard Imaging Pipspro Qa Software System
FDA 510(k) K042733 · Standard Imaging, Inc.
510(k) numberK042733
Submission
- Device name
- Standard Imaging Pipspro Qa Software System
- Applicant
- Standard Imaging, Inc.
Middleton, WI, US - Received
- October 1, 2004
- Decision date
- November 15, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LHO
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|---|---|---|---|
| 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 |
| K834483 | Digi-XLHO · Traditional | Radiation Measurements, Inc. | 03/05/1984SE |
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| K040688 | Standard Imaging E.Imrt CalculatorMUJ · Traditional | 05/11/2004SE |
| K013548 | Standard Imaging Ivb 1000 Well ChamberKPT · Special | 11/09/2001SE |
| K002833 | Modification to Standard Imaging PT 1000 Ion ChamberKPT · Special | 09/28/2000SE |
| K001825 | Standard Imaging HDR 1000 Plus Ion Chamber; Standard Imaging Ivb 1000 Ion ChamberJAQ · Special | 08/02/2000SE |
| K940539 | Stand Imaging Dose Calibrator Shielded Work PlatformKPY · Traditional | 03/16/1994SE |
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Questions and answers
When was Standard Imaging Pipspro Qa Software System cleared by the FDA?
Standard Imaging Pipspro Qa Software System (K042733) received a 510(k) decision of Substantially Equivalent on November 15, 2004, 45 days after the submission was received.
What is the product code of K042733?
The FDA product code is LHO – Instrument, Quality-Assurance, Radiologic, a Class I (low risk) device regulated under 21 CFR 892.1940.