510(k) K973463
K973463 is an FDA 510(k) premarket notification submitted by O Tech, Inc. for the device "OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE". The FDA issued a decision of Substantially Equivalent on December 2, 1997. The device falls under product code LMB (Device, Digital Image Storage, Radiological), a Class I device regulated under 21 CFR 892.2010. O Tech, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1997
- Date Received
- September 12, 1997
- 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
Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.