Atlas FDA

KXJ

31 FDA 510(k) clearances · Product code

42 daysmedian time to decision
92 days90th percentile
31clearances measured

FDA profile

Official device name
Table, Radiologic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1980
Medical specialty
Radiology
Adverse events (MAUDE)
2010: 5 · 2011: 19 · 2012: 5 · 2017: 12 · 2018: 31 · 2022: 50
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
APOLLO (K050190)Villa Sistemi Medicali S.P.A.2005-03-25
RADIOGRAPHIC ITT TABLE (K963905)X-Ray Technologies, Inc.1996-11-12
XRT 400 (K955414)Wuestec Medical, Inc.1996-07-24
IMAGING TABLE (K951146)Septa Corp.1995-05-04
CARBON FIBER COUCH INSERT (K950068)Medtec, Inc.1995-04-06
INFRARED EXPOSURE HAND SWITCH (K950442)Medical X-Ray Intl., Inc.1995-03-31
SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5 (K940696)Philips Medical Systems North America, Inc.1994-03-16
ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES (K931724)Continental X-Ray Corp.1993-06-14
MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM (K926407)Nucletron-Oldelft Corp.1993-03-31
CAG-02A (K922098)Toshiba America Medical Systems, In.C1992-07-27
OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 (K913121)Continental X-Ray Corp.1991-08-16
RADKOR, RF-159 (K883885)Radkor, Inc.1988-10-19
RASTIX X-RAY TABLE (K883155)Bay X-Ray, Inc.1988-09-06
RADKOR KOB-84 (K881700)Radkor, Inc.1988-09-02
UNIVERSAL EXAMINATION TABLE (K874934)Imatron, Inc.1988-01-19
REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100 (K874639)Shimadzu Precision Instruments, Inc.1987-12-04
OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER (K871827)General Electric Co.1987-06-19
X-MAT (K862144)Combined Concepts, Inc.1986-06-25
SHAMPAINE RADI-OP MODEL 1700RC (K860620)Smith & Nephew, Inc.1986-04-08
MEDEX X-RAY TABLE (K854328)Philips Medical Systems (Cleveland), Inc.1986-01-28
CHICK/REISON PATIENT EMERG. TROLLEY (K834478)Professional Medical Products, Inc.1984-02-21
SIEMENS SIRESKOP 4 (K820111)Siemens Corp.1982-02-18
PORTABLE MEDICAL TABLE (K812791)Richard D. Spradlin1981-11-24
DUAL PEDESTAL TABLE (K811969)Philips Medical Systems (Cleveland), Inc.1981-08-13
ALLMEC 90/15 (K811196)Tecnomed, Inc.1981-06-09
TILTING IMAGING TABLE #846T (K803120)Quinton, Inc.1981-01-22
KOORDINAT 3D (K790783)Siemens Corp.1979-05-07
COORDINATUS, HORIZONTAL RADIOGRAPHOC (K790743)Pausch Corp.1979-04-23
TELEVIX (K790692)General Electrical Espanola, S.A.1979-04-23
CLEARVIEW (K790536)Hipoint Research, Inc.1979-03-28
KOORDINAT ANGIO (K781992)Siemens Corp.1978-12-07

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