Atlas FDA

IXY

21 FDA 510(k) clearances · Product code

56 daysmedian time to decision
145 days90th percentile
21clearances measured

FDA profile

Official device name
Holder, Radiographic Cassette, Wall-Mounted
Device class
Class I (low risk)
Regulation
21 CFR 892.1880
Medical specialty
Radiology
Adverse events (MAUDE)
1995: 1 · 1996: 1 · 1999: 9 · 2000: 3 · 2002: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
VRS 3 WALL STAND (K953336)Philips Medical Systems (Cleveland), Inc.1995-08-11
UNIVERSIX 190 (K953402)Philips Medical Systems (Cleveland), Inc.1995-08-11
SENSORI-MOTOR RATING SCALE (K946114)Cmed1995-04-28
NTBS-1417, 1436, TBS-1417 (K946260)Scott Imaging Intl., Inc.1995-03-31
RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER (K930230)American Medical Sales, Inc.1993-04-27
BC/WT/PF (K930249)Tingle X-Ray Products, Inc.1993-04-27
WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (K925934)Continental X-Ray Corp.1993-03-04
BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY (K924445)Control-X, Inc.1993-02-19
VERT-X UNIVERSAL VERTICAL BUCKY STAND (K922443)Afp Imaging Corp.1992-10-26
MODEL H170 PEDIATRIC CHEST X-RAY UNIT (K915667)H.L. Lyons Co.1992-01-31
BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C (K895034)Yamato Medical Corp.1989-11-15
RADKOR BS-10 AND BS-10T (K891395)Radkor, Inc.1989-04-03
SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS (K872132)Sopha Medical Systems, Inc.1987-10-26
BSX BUCKY-STAND (K862828)Garrels X-Ray Products, Inc.1986-08-01
BASICAM S COUNTER BALANCE CAMERA (K860454)Siemens Gammasonics, Inc.1986-02-21
DYNAMIC CARDIAC PHANTOM 74-347 (K853756)Victoreen, Inc.1985-10-29
RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR (K851440)Summit Industries, Inc.1985-06-05
MULTI-SIZE CASSETTE HOLDER (K850125)Philips Medical Systems (Cleveland), Inc.1985-03-26
WALL CASSETTE HOLDER - TRAC44 (K810194)Philips Medical Systems (Cleveland), Inc.1981-02-25
PELICAN BAY KEL-COR CEPHALOMETRIC SYS. (K791916)Pelican Bay Kel-Cor1979-11-05
KS-78 VERTICAL WALL CASSETTE HOLDER (K790742)Pausch Corp.1979-04-26

Track IXY automatically

Every clearance here is in the API, with alerts when new ones post.