510(k) K944772
K944772 is an FDA 510(k) premarket notification submitted by Image Diagnostics, Inc. for the device "MULTIPLE ED1600 SERIES RADIATION SHIELDS". The FDA issued a decision of Substantially Equivalent on October 20, 1994. The device falls under product code EAK (Screen, Leaded, Operator Radiation Protector), a Class I device regulated under 21 CFR 892.6500. Image Diagnostics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1994
- Date Received
- September 27, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screen, Leaded, Operator Radiation Protector
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type