SIREDOC 60 AND SIREDOC 220
FDA 510(k) clearance K863331 · decided 1986-10-06
Clearance details
- K-number
- K863331
- Device name
- SIREDOC 60 AND SIREDOC 220
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-27
- Decision date
- 1986-10-06
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- DSF
- Device class
- 1
- Regulation number
- 870.2810
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Iselin, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Siemens Medical Solutions USA
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EDENTEC DIGITAL CHARTER MODEL 3710 (K910871) | Edentec Corp. | 1991-08-29 |
| DASH IV (K912929) | Astro-Med, Inc. | 1991-08-13 |
| MODEL 556 MONITOR (K905856) | Ge Medical Systems Information Technologies | 1991-01-11 |
| GRI LASERGRAPH(TM) ECG PAPER (K902586) | Gri Medical Products, Inc. | 1990-06-22 |
| COLORADO COLOR IMAGING RECORDER (K902230) | Honeywell, Inc. | 1990-06-19 |
| GABRIEL MEDICAL CLS THERMAL RECORDER (K901385) | Gabriel Medical, Inc. | 1990-05-09 |
| TYPE 9541 RECORDER, PAPER CHART (K895111) | S & W Medico Teknik | 1990-01-26 |
| WR3500 AND WR3600 SERIES RECORDERS (K894922) | Western Graphtec | 1990-01-26 |
| MT96000 PAPER CHART RECORDER (K894736) | Astro-Med, Inc. | 1989-12-13 |
| PAQ10 PAPER CHART RECORDER (K894607) | Protocol Systems, Inc. | 1989-10-26 |
| EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. (K893561) | Edentec Corp. | 1989-08-25 |
| CARDIOCAP(TM) DR-104 REPORTER (K885058) | Datex Division Instrumentarium Corp. | 1989-07-14 |
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 |