510(k) K991643
K991643 is an FDA 510(k) premarket notification submitted by O Tech, Inc. for the device "IDS4 V3.2 IMAGE DISPLAY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 8, 1999. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. O Tech, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 1999
- Date Received
- May 13, 1999
- 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