Product code IWE— Radiology
CENTRALITE BACKPOINTER
- Classification name
- Monitor, Patient Position, Light-Beam
- Device class
- Class 1
- Regulation
- 21 CFR 892.5780
- Advisory panel
- Radiology
- Total cleared
- 28
- First cleared
- Most recent
Market context for product code IWE
FDA has cleared devices under product code IWE between 1980 and 2015, filed by 14 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2015
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1980
Top applicants under product code IWE
Recent clearances under product code IWE
- K152303 — CT Sim Laser System
- K973162 — DUAL RADIATION TARGETING SYSTEM DRTS DRAPE
- K955236 — GREEN TEC-2100
- K954414 — CENTRALITE BACKPOINTER
- K950293 — TEC-2110 GREEN LASER MODEL MT-HNG
- K950112 — CENTRALITE(R)-DLL SERIES
- K951601 — MED-TEC STRING RETICLE TRAY
- K943802 — HP BACK POINTER SYSTEM
- K943381 — LASER ALIGNMENT TOOL
- K941169 — TEC 2101 (MODEL MT-HPLGD)
- K935760 — TEC 2100 (MODEL MT-LPLGD)
- K934519 — RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM
- K931974 — AZ 92
- K930294 — PATPOS GREEN
- K930295 — PATPOS COMPACT
- K930296 — PATPOS RED
- K923619 — ACCULITE SSL
- K904127 — A2J TELEMETER
- K904753 — DIOLASE
- K893398 — CENTRALITE BACKPOINTER
- K880981 — A2J MZ 44 B TYPE
- K872841 — ACCULITE
- K872894 — A2J MZ 44 LASER LIGHT FOR POSITIONING
- K872489 — CENTRALITE
- K860472 — NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS
- K801541 — WALL MOUNTED LASER POSITIONING DEVICE
- K800489 — LASER BACKPOINTER ASSEMBLY, MOD. 01-2487
- K800223 — PATIENT POSITIONING SYSTEM 1D OR 2D
Data sourced from openFDA. This site is unofficial and independent of the FDA.