LITHOSKOP
FDA 510(k) clearance K070665 · decided 2008-01-04
Clearance details
- K-number
- K070665
- Device name
- LITHOSKOP
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-03-12
- Decision date
- 2008-01-04
- Days to decision
- 298 days
- Clearance type
- Traditional
- Product code
- LNS
- Device class
- 2
- Regulation number
- 876.5990
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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| Break Wave (K252913) | Sonomotion, Inc. | 2026-01-12 |
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| Delta III Pro (K221903) | Dornier Medtech America, Inc. | 2023-02-22 |
| LM-9300 Plus Lithotripter (K213772) | Lite-Med, Inc. | 2023-01-19 |
| Modulith SLX-F2 (K201001) | Karl Storz Endoscopy America | 2021-03-30 |
| Delta III Lithotripter (K201074) | Dornier Medtech America, Inc. | 2020-09-03 |
| Delta III Lithotripter (K172084) | Dornier Medtech America, Inc. | 2017-08-08 |
| Delta III Lithotripter (K170122) | Dornier Medtech America | 2017-06-28 |
| Gemini XXP-HP (K151298) | Dornier Medtech America | 2015-07-30 |
| LM-9300 ELMA Lithotripter (K142561) | Lite-Med, Inc. | 2015-03-20 |
| EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (K131817) | Osmunda Medical Device Consulting Co., Ltd. | 2014-09-26 |
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 |