Atlas FDA

ITY

40 FDA 510(k) clearances · Product code

67 daysmedian time to decision
206 days90th percentile
40clearances measured

FDA profile

Official device name
Assembly, Tube Housing, X-Ray, Diagnostic
Device class
Class I (low risk)
Regulation
21 CFR 892.1760
Medical specialty
Radiology
Adverse events (MAUDE)
1998: 4 · 2000: 2 · 2001: 7 · 2003: 3 · 2004: 3 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 (K000052)Dynarad Corp.2000-02-10
MRX-750 (K933162)Mrx Corp.1993-10-07
MOLYBDENUM (K923094)Southeastern Medical Diagnostics, Inc.1993-03-04
PHILIPS PRE-FILTER OPTION (K923141)Philips Medical Systems, Inc.1993-01-21
MRX-700 (K921129)Mrx-Ray Tube Corp.1992-10-05
MRX-865 (K921130)Mrx-Ray Tube Corp.1992-09-10
MG-1001 TUBE HOUSING ASSEMBLY (K921316)Magma Corp.1992-06-22
X-RAY TUBE ASSEMBLY CIRCLEX1.2UG (K920731)Shimadzu Medical Systems1992-05-29
HIGH SPEED ROTATION STARTER SA-50 (K920724)Shimadzu Medical Systems1992-04-27
HIGH SPEED ROTATION STARTER SA-40 (K920723)Shimadzu Medical Systems1992-04-27
CIRCLEXO.3T X-RAY TUBE ASSEMBLY (K920387)Shimadzu Medical Systems1992-04-14
OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID (K913987)Codman & Shurtleff, Inc.1992-04-13
MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM (K913301)Comet North America, Inc.1991-08-28
TUBE HOUSING ASSEMBLIES (K912338)Comet Ltd. C/O Radiology Resources, Inc.1991-08-07
VARIOUS X-RAY TUBES (K911695)Comet Ltd. C/O Radiology Resources, Inc.1991-06-19
X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 (K910308)Inmark Corp.1991-03-27
X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51 (K910276)Inmark Corp.1991-03-06
DI2000/HS-45-150 X-RAY TUBE INSERT (K910842)Comet Ltd. C/O Radiology Resources, Inc.1991-03-06
R-800-SF (K904182)Advantech1990-11-13
HOFMANN-NAGEL (HOFNA) X-RAY TUBES (K900367)Hofmann1990-02-26
RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS (K894742)Inmark Corp.1989-10-27
X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS (K894413)Inmark Corp.1989-09-22
NIOBI-X RADIATION REDUCTION FILTER (K882939)American Canadian Products, Inc.1988-11-04
MEICOR X-RAY TUBE, MODELS MC1000, MC1500, MC2000 (K882323)Meicor, Inc.1988-06-30
TOSHIBA, SMIT ROENTGEN (K873314)Inland Tube Corp.1987-11-02
LES RAD FILTER (K871227)M. D. Products1987-06-29
TOSHIBA, SMIT ROENTGEN (K870071)North American Imaging, Inc.1987-01-21
MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH (K864042)Absolute X-Ray Corp.1986-10-27
ERBIUM X-RAY FILTER (K860760)Reactor Experiments, Inc.1986-06-10
36-101 XDS111 XENON DELIVERY/TRAP SYSTEM (K860504)Victoreen, Inc.1986-04-04
CRISA (K840135)X-Ray Tube Corp.1984-03-23
PHASIX-HIGH FREQUENCY GENERATOR (K834306)Cgr Medical Corp.1983-12-29
CRISA (K833847)X-Ray Tube Corp.1983-12-12
CRISA (K833238)X-Ray Tube Corp.1983-10-28
MX 125 (K812915)General Electric Co.1981-11-24
OPTI 110/12/50HSG (K810190)Siemens Corp.1981-03-02
MAXIRAY 125 TUBE UNIT (K781524)General Electric Co.1978-10-17
OPTI 110/12/50 HSG (K781540)Siemens Corp.1978-09-14
X-RAY TUBE, ROTATING ANODE (K770336)Litton Medical Systems1977-03-01
EUREKA X-SCAN 150 X-RAY TUBE HOUSING AS. (K760604)Eureka X-Ray Tube Corp.1976-09-13

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