WISE (II) IMAGE MANAGEMENT SYSTEM
FDA 510(k) clearance K983447 · decided 1998-10-29
Clearance details
- K-number
- K983447
- Device name
- WISE (II) IMAGE MANAGEMENT SYSTEM
- Applicant
- Sectra-Imtec AB
- Decision
- Substantially Equivalent
- Date received
- 1998-09-30
- Decision date
- 1998-10-29
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- LMB
- Device class
- 1
- Regulation number
- 892.2010
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Plano, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sectra-Imtec AB
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Easy Access Image Management System with CL.Net. recall (Z-0695-05) | Philips Medical Systems Sales & Service Region No. America | 2005-04-08 |
| Easy Access PACS System with software Release 5, 6.2, or 7.2 recall (Z-1223-03) | Philips Medical Systems | 2003-09-12 |
| Easy Access Software releases 1.1, 5.2, 6.2 & 7.2 recall (Z-1125-03) | Philips Medical Systems | 2003-08-12 |