STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
FDA 510(k) clearance K042733 · decided 2004-11-15
Clearance details
- K-number
- K042733
- Device name
- STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
- Applicant
- Standard Imaging, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-10-01
- Decision date
- 2004-11-15
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- LHO
- Device class
- 1
- Regulation number
- 892.1940
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Middleton, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ULTIMETER (K873956) | Radiation Measurements, Inc. | 1987-10-30 |
| MULTI PURPOSE MODEL 76-903 (K860260) | Victoreen, Inc. | 1986-05-07 |
| MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901 (K853754) | Victoreen, Inc. | 1986-05-07 |
| MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902 (K860100) | Victoreen, Inc. | 1986-04-22 |
| BDS-3 BEAM DATA SCANNER (K844620) | Varian Assoc., Inc. | 1985-07-01 |
| RFA-7 RADIATION FIELD ANALYZER (K845007) | Varian Assoc., Inc. | 1985-07-01 |
| DIGI-X (K834483) | Radiation Measurements, Inc. | 1984-03-05 |
Recalls involving this device
No recalls on record reference this clearance.