510(k) K012155
K012155 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS". The FDA issued a decision of Substantially Equivalent on August 10, 2001. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Eastman Kodak Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2001
- Date Received
- July 11, 2001
- 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