Wfr/Aquaplast Corp.

• IYE — Radiology3 devices
• JAI — Radiology2 devices
• EMA — Dental1 device
• EPP — Ear, Nose, Throat1 device
• LZM — General, Plastic Surgery1 device

• Z-1264-2016 — Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy. It may be used with CT and MR scanners to acquire images for radiation therapy planning.Class II·Terminated·2016-01-07

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K120916 — QFIX RADIOTHERAPY CHAIRCode JAI·2012-06-20
• K060671 — KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUSCode JAI·2006-05-04
• K032156 — ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENTCode IYE·2003-09-02
• K021124 — ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDERCode IYE·2002-07-02
• K973370 — AQUAPLAST PALATAL STENTCode EMA·1997-12-02
• K943871 — AQUAPLAST TIE DOWN DRESSINGCode LZM·1994-09-30
• K942158 — AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITSCode EPP·1994-07-29
• K935067 — AQUAPLASTCode IYE·1994-05-26