510(k) K973028
K973028 is an FDA 510(k) premarket notification submitted by Sterling Diagnostic Imaging, Inc. for the device "HELIOS LASER IMAGER 1417". The FDA issued a decision of Substantially Equivalent on October 28, 1997. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Sterling Diagnostic Imaging, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 1997
- Date Received
- August 14, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Multi Format, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2040
- Review Panel
- RA
- Submission Type