510(k) K841996
K841996 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "MAXICAMERA 400T W/BODY CONTOUR TOMOGRA". The FDA issued a decision of Substantially Equivalent on July 16, 1984. The device falls under product code JAM (Scanner, Whole Body, Nuclear), a Class I device regulated under 21 CFR 892.1330. General Electric Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1984
- Date Received
- May 16, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scanner, Whole Body, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1330
- Review Panel
- RA
- Submission Type