510(k) K052473
K052473 is an FDA 510(k) premarket notification submitted by Inter Medical Medizintechnik GmbH for the device "CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000". The FDA issued a decision of Substantially Equivalent on Oct 28, 2005. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. Inter Medical Medizintechnik GmbH has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 28, 2005
- Date Received
- Sep 9, 2005
- 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
- 510(k)