FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDX ROTATIONAL GANTRY SYSTEM
K Number: K923356
·
Decision Sep 21, 1992
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
6
Review Days
75
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MEDX ROTATIONAL GANTRY SYSTEM
- K Number
- K923356
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bfi- Medical Waste Systems
- Date Received
- July 8, 1992
- Decision Date
- September 21, 1992
- Product Code
- IYX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYX), ordered by most recent decision date.
QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)
FDA 510(k)
FDA Class 1
·Radiology
3D-RD-S
FDA 510(k)
FDA Class 1
·Radiology
OLINDA EXM
FDA 510(k)
FDA Class 1
·Radiology
Discovery NM 750b Bopsy
FDA 510(k)
FDA Class 1
·Radiology
Sentinella 102, Sentinella 102 Horus
FDA 510(k)
FDA Class 1
·Radiology
Sentinella 102; Sentinella 102 Horus
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by Bfi- Medical Waste Systems
| K Number | Device Name | ||
|---|---|---|---|
| K981184 | SHARPTRACK REUSABLE SHARPS CONTAINER | Jun 22, 1998 | Substantially Equivalent |
| K943771 | MEDX REUSABLE SHARPS CONTAINER | Mar 3, 1995 | Substantially Equivalent |
| K943794 | MX4000 | Dec 14, 1994 | Substantially Equivalent |
| K843582 | MULTI-FORMAT FILM CAMERA | Oct 25, 1984 | Substantially Equivalent |
| K827761 | MED-X MODEL 301 X-RAY FILTER | Aug 10, 1982 | Substantially Equivalent |