510(k) K073456
K073456 is an FDA 510(k) premarket notification submitted by Medx, Inc. for the device "T-QUEST SYSTEM". The FDA issued a decision of Substantially Equivalent on December 20, 2007. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. Medx, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2007
- Date Received
- December 10, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Camera, Scintillation (Gamma)
- Device Class
- Class I
- Regulation Number
- 892.1100
- Review Panel
- RA
- Submission Type