SIRECUST 420 PATIENT DIALOG MONITOR
FDA 510(k) clearance K851400 · decided 1985-06-26
Clearance details
- K-number
- K851400
- Device name
- SIRECUST 420 PATIENT DIALOG MONITOR
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-09
- Decision date
- 1985-06-26
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- DXJ
- Device class
- 2
- Regulation number
- 870.2450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Iselin, NJ, 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 |
|---|---|---|
| ESSENZ Patient Monitor (K212003) | Livanova Deutschland, GmbH | 2021-11-10 |
| Philips IntelliVue GuardianSoftware (Rev. E.0X) (K212208) | Philips Medizin Systeme Boeblingen GmbH | 2021-09-30 |
| Essence 55SP Large Monitor System (K201162) | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2020-08-27 |
| Vios Central Station Monitor Software, Vios Central Server Software (K173107) | Vios Medical, Inc. | 2018-07-26 |
| Philips IntelliVue GuardianSoftware (K180534) | Philips Medizin Systeme Boeblingen GmbH | 2018-07-16 |
| Nexxis OR (K173381) | Barco N.V. | 2018-02-22 |
| Essence 55S Large Monitor System (K172969) | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2018-01-26 |
| Sorin Connect (K170460) | Sorin Group Deutschland GmbH | 2017-06-08 |
| Nexxis OR, Nexxis (K170537) | Barco N.V. | 2017-04-21 |
| NIVR58-T kit (K161880) | Barco N.V. | 2017-03-14 |
| Philips IntelliVue GuardianSoftware (K161767) | Philips Medizin Systeme Boeblingen GmbH | 2017-01-27 |
| CARESCAPE Central Station V2 (K162012) | GE Healthcare | 2016-09-15 |
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/S009) | Siemens Medical Solutions USA, Inc. | 2026-07-01 |
| 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 |