SIENET SPI SPOOLER
FDA 510(k) clearance K953552 · decided 1995-10-24
Clearance details
- K-number
- K953552
- Device name
- SIENET SPI SPOOLER
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-28
- Decision date
- 1995-10-24
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- LMD
- Device class
- 1
- Regulation number
- 892.2020
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Iselin, NJ, US
- Third-party review
- No
- Expedited review
- No
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| STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM (K984000) | Surgical Navigation Technologies, Inc. | 1999-01-12 |
| IMAGEQUEST (K974707) | Visual Med, Inc. | 1998-07-31 |
| KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW (K981053) | Eastman Kodak Company | 1998-06-18 |
| JPACS (K980918) | Philips Medical Systems (Cleveland), Inc. | 1998-06-03 |
| DOWNSCAN LT (K974882) | Merlin Engineering Works, Inc. | 1998-05-22 |
| VR NETSERVE (K980684) | I.S.G. Technologies, Inc. | 1998-05-06 |
| BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY (K980541) | Barco NV Display Systems | 1998-04-09 |
Recalls involving this device
No recalls on record reference this clearance.
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 |