510(k) K891485
K891485 is an FDA 510(k) premarket notification submitted by Andros Analyzers, Inc. for the device "ANGIOTEC FMX-2220 SYSTEM". The FDA issued a decision of Substantially Equivalent on May 5, 1989. The device falls under product code LMB (Device, Digital Image Storage, Radiological), a Class I device regulated under 21 CFR 892.2010. Andros Analyzers, Inc. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 1989
- Date Received
- Mar 17, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Device, Digital Image Storage, Radiological
- Device Class
- Class I
- Regulation Number
- 892.2010
- Review Panel
- RA
- Submission Type
- 510(k) Exempt
Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.