Cradle, Patient, Radiologic
Radiology · 21 CFR 892.1830
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
2 recall events for this product code
- Med Tec IncTerminatedUnknown
CIVCO Arm Support, REF 106015, distributed as:
Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.
Z-3082-2017 · View FDA record ↗ - Med Tec IncTerminatedUnknown
CIVCO Arm Support, REF 106047, distributed as:
Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.
Z-3083-2017 · View FDA record ↗
Registered firms
19 firms currently registered for this product code
Huestis Machine Corp.
Bristol, RI, US
Ge Medical Systems Israel, Functional Imaging
Haifa, IL
Pearl Technology Ag
Schlieren Zurich, CH
Reina Imaging
CRYSTAL LAKE, IL, US
First Source Inc.
Rochester, NY, US
Alcare Co., Ltd Chiba Factory, East
CHIBA CITY, JP
Hyperfine, Inc
Guilford, CT, US
Octostop, Inc.
LAVAL Quebec, CA
Depuy Orthopaedics, Inc.
WARSAW, IN, US
The Initiative Llc., Dba Kypholift
South Jordan, UT, US
Ge Medical Systems Israel, Functional Imaging
TIRAT HACARMEL Haifa, IL
Ge Medical Systems Israel, Functional Imaging
Haifa, IL
Armery Medical Technologies Inc.
London Ontario, CA
Anatomical Geometry S.l.
MAIRENA DEL ALJARAFE Sevilla, ES
Creative Foam Corporation - Bremen
BREMEN, IN, US
Orchid Orthopedic Solutions Alabama Llc
Arab, AL, US
Guangdong Meicen Medical Equipment Co., Ltd.
foshan Guangdong, CN
Ge Healthcare Coils
AURORA, OH, US
Guangzhou Tian Hong Medical Technology Co., Ltd.
Guangzhou Guangdong, CN
510(k) clearances
9 clearances for this product code
- Ge Healthcare Coils (Usa Instruments, Inc.)Nov 16, 2012
K122174 · PEDIATRIC POSITIONER PAD SET
- Octostop, Inc.Sep 29, 1995
K953246 · OCTOROLL
- Octostop, Inc.Feb 9, 1994
K930124 · VARIANT OF OCTOSTOP AND OCTOPAQUE
- Spectrum X-Ray Corp.Oct 7, 1993
K933134 · SPECTRUM DG-P7000 PEDIATRIC CRADLE
- Octostop, Inc.Jul 13, 1993
K930357 · ACCESSORY TO UNIVERSAL OCTOPAQUE
- Fischer Imaging Corp.Mar 31, 1989
K884292 · STRETCHER TABLE
- Ar Custom Medical Products, Ltd.Oct 14, 1986
K863890 · MAMM-AIRE
- Spectrum X-Ray Corp.Feb 21, 1984
K840463 · DIGITAL CRADLE