510(k) K001140
K001140 is an FDA 510(k) premarket notification submitted by Sectra AB for the device "IDS5 IMAGE DISPLAY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 3, 2000. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Sectra AB has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2000
- Date Received
- April 10, 2000
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type