510(k) K892869
K892869 is an FDA 510(k) premarket notification submitted by Andros Analyzers, Inc. for the device "ANGIOTEC ZX DIGITAL IMAGE PROCESSOR". The FDA issued a decision of Substantially Equivalent on May 26, 1989. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Andros Analyzers, Inc. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 1989
- Date Received
- Apr 19, 1989
- Clearance Type
- Traditional
- 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
- 510(k)