SIRECUST 341 AND 341R
FDA 510(k) clearance K854881 · decided 1986-03-11
Clearance details
- K-number
- K854881
- Device name
- SIRECUST 341 AND 341R
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-12-06
- Decision date
- 1986-03-11
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- DRT
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Iselin, NJ, US
- Third-party review
- No
- Expedited review
- No
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| The Circadia C200 System (K234003) | Circadia Technologies, Ltd. | 2024-05-30 |
| Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software (K232354) | Murata Vios, Inc. | 2024-03-22 |
| Neteera 130H-Plus Vital Sign Monitoring Sensor (K231733) | Neteera Technologies , Ltd. | 2024-02-09 |
| Sleepiz One+ (K223163) | Sleepiz AG | 2023-08-18 |
| Neteera 130H/131H Vital Sign Monitoring Sensor (K212143) | Neteera Technologies , Ltd. | 2022-09-28 |
| Cardiac Trigger Monitor (K202138) | Ivy Biomedical Systems, Inc. | 2021-05-14 |
| Vital Sign Monitoring Sensor (Model :XK300) (K202464) | Xandar Kardian, Inc. | 2021-04-26 |
| Philips wearable biosensor-G5 Solution (K181165) | Connected Sensing- A Division of Philips Medical Systems | 2019-03-07 |
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 |