SIMVIEW(TM) 3000
FDA 510(k) clearance K946053 · decided 1995-03-31
Clearance details
- K-number
- K946053
- Device name
- SIMVIEW(TM) 3000
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-12
- Decision date
- 1995-03-31
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- KPQ
- Device class
- 2
- Regulation number
- 892.5840
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Concord, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT op recall (Z-0646-2009) | Siemens Medical Solutions USA, Inc | 2009-01-13 |
| Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and M recall (Z-2196-2008) | Siemens Medical Solutions USA, Inc | 2008-06-28 |
| Si emans Simiae 3000 Cassette Holder Electronic Imaging device (Image Identifier), with CT recall (Z-0281-2008) | Siemens Medical Solutions USA, Inc | 2008-01-31 |
| Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with CT, recall (Z-0283-2008) | Siemens Medical Solutions USA, Inc | 2008-01-31 |
| Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with IDI, recall (Z-0284-2008) | Siemens Medical Solutions USA, Inc | 2008-01-31 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008) | Siemens Medical Solutions USA, Inc. | 2024-09-23 |
| MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007) | Siemens Medical Solutions USA, Inc. | 2020-08-21 |
| MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006) | Siemens Medical Solutions USA, Inc. | 2019-12-10 |
| Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005) | Siemens Medical Solutions USA, Inc. | 2017-09-29 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003) | Siemens Medical Solutions USA, Inc. | 2017-03-23 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001) | Siemens Medical Solutions USA, Inc. | 2016-05-12 |
| MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002) | Siemens Medical Solutions USA, Inc. | 2016-01-13 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011) | Siemens Medical Solutions USA, Inc. | 2015-04-21 |