Atlas FDA

IZO

163 FDA 510(k) clearances · Product code

60 daysmedian time to decision
147 days90th percentile
163clearances measured

FDA profile

Official device name
Generator, High-Voltage, X-Ray, Diagnostic
Device class
Class I (low risk)
Regulation
21 CFR 892.1700
Medical specialty
Radiology
Adverse events (MAUDE)
2006: 2 · 2007: 3 · 2008: 5 · 2011: 15 · 2012: 7 · 2013: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MPH50, MPH65, AND MPH80 (K954666)GE Medical Systems1995-11-24
HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR (K953582)Varian Canada, Inc.1995-09-26
N 800 HF (K953831)Nucletron-Oldelft Corp.1995-09-08
SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G (K952822)Shimadzu Corp.1995-07-12
MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR (K952265)Control-X, Inc.1995-07-06
POLYDOROS SX 65 AND 80 (K950883)Siemens Medical Solutions USA, Inc.1995-04-03
COMPACT-X (K950694)Electromed Intl., Ltd.1995-03-31
DIGITAL 625HF (K950291)Fischer Imaging Corp.1995-03-23
UD 150L-R II (K945453)Shimadzu Medical Systems1995-03-21
SII 525 APR (K950040)Scott Imaging Intl., Inc.1995-03-21
SII 360 APR (K950041)Scott Imaging Intl., Inc.1995-03-21
UD 150L-F (K945452)Shimadzu Medical Systems1995-03-21
N 800 HF (K950037)Oldelft Corp. of America1995-02-15
HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS (K945731)Bennett X-Ray Corp.1995-02-15
KXO-80G (K945668)Toshiba America Medical Systems, In.C1994-12-27
SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR (K942731)Shimadzu Corp.1994-10-13
MICRO X-80 HF (K944149)Fischer Imaging Corp.1994-09-16
MICRO X-50 HF (K944147)Fischer Imaging Corp.1994-09-16
MICRO X-30HF (K944148)Fischer Imaging Corp.1994-09-16
MICRO X-65 HF (K944150)Fischer Imaging Corp.1994-09-16
VASCULAR MP X-RAY GENERATOR (K943652)GE Medical Systems1994-08-22
RSX-525HF (K943504)Fischer Imaging Corp.1994-08-17
MODEL VPW2877F8, MAMMO 5 POWER SUPPLY (K942778)Varian Assoc., Inc.1994-07-29
MODEL TM EP HIGH VOLTAGE GENERATOR (K942100)Continental X-Ray Corp.1994-06-07
MOLYBDENUM/RHODIUM FILTERS (K934686)Continental X-Ray Corp.1994-05-26
SCPU X-RAY GENERATOR (K940227)General Electric Co.1994-04-28
SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR (K934967)Shimadzu Corp.1993-12-13
CONCEPT ONE (K933777)Innerscan, Inc.1993-12-13
RADIOGRAPHIC GENERATOR HFQ-WHIS (K935068)Bennett X-Ray Corp.1993-12-13
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G (K933471)Shimadzu Corp.1993-11-24
PHILIPS XRG 90 X-RAY GENERATOR SYSTEM (K933650)Philips Medical Systems North America, Inc.1993-10-07
POLYDOROS IS (K933240)Siemens Medical Solutions USA, Inc.1993-09-07
POYDOROS LX (K931930)Siemens Medical Solutions USA, Inc.1993-09-07
LCR GENERATOR (K931998)Philips Medical Systems (Cleveland), Inc.1993-07-27
RSX 30HF (K930792)Fischer Imaging Corp.1993-05-19
ADVANTX SYSTEM (K931049)GE Medical Systems1993-05-19
MAGMA XHF-30, XHF-40, XHF-50 (K926365)Imaging and X-Ray Intl., Inc.1993-03-26
PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR (K920349)Control-X, Inc.1993-02-12
PCX 650HF RADIOGRAPHIC X-RAY (K920351)Control-X, Inc.1993-02-12
OLYMP-X,X-RAY GENERATOR (K925684)Afp Imaging Corp.1993-02-02
POLYDOROS C (K924078)Siemens Medical Solutions USA, Inc.1993-01-26
PHILIPS SUPER CP FAMILY (K925844)Philips Medical Systems, Inc.1992-12-28
PHILIPS MEDIO CP FAMILY (K925105)Philips Medical Systems, Inc.1992-12-28
POLYDOROS XS50 AND SX80 (K923786)Siemens Medical Solutions USA, Inc.1992-12-17
X-RAY CONTROL AND HI-VOLTAGE GENERATOR (K921875)Continental X-Ray Corp.1992-10-15
TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT (K922814)Bay Shore Medical Equipment Corp.1992-09-11
ATC725, ATC525, AND AP300 (K922165)Gendex Corp.1992-07-27
MPG 65-80-100 X-RAY GENERATOR AND CONTROL (K921951)General Electric Co.1992-07-21
P2900 X-RAY GENERATOR (K921516)Precise Optics Photo Medic Equipment, Inc.1992-05-28
X-RAY HIGH VOLTAGE GENERATOR ED 125L (K920730)Shimadzu Medical Systems1992-04-27
GEN-X 800/300 (K915339)Swissray Finatech, Inc.1992-01-09
GEN-X 800/500 (K915227)Swiss Ray Medical Systems1992-01-09
OPTIMA (K913222)Olympic Controls Corp.1991-12-20
MICRO-X 30 HF (K914266)Fischer Imaging Corp.1991-11-27
MICRO-X 50 HF (K914236)Fischer Imaging Corp.1991-11-27
MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR (K913577)Control-X, Inc.1991-11-05
MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR (K913578)Control-X, Inc.1991-11-01
GEN-X 800/650 (K914302)Swissray Finatech, Inc.1991-10-30
GEN-X 800/800 (K914301)Swissray Finatech, Inc.1991-10-30
EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR (K911562)Continental X-Ray Corp.1991-10-24
VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY (K913234)Varian Canada, Inc.1991-09-23
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10 (K913062)Shimadzu Medical Systems1991-09-16
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10 (K913063)Shimadzu Medical Systems1991-09-16
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L (K913064)Shimadzu Medical Systems1991-09-16
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L (K913065)Shimadzu Medical Systems1991-09-16
MICRO-X 15 HF (K912449)Fischer Imaging Corp.1991-08-28
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B (K911280)Shimadzu Medical Systems1991-06-17
SELECTOR MD (50KW AND 80 KW) (K910650)Hofmann-Nagel Medical Systems, Inc.1991-06-06
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K (K911339)Shimadzu Medical Systems1991-04-16
CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS (K910020)Capintec Instruments, Inc.1991-04-08
VPW 2877E6 X-RAY POWER SUPPLY (K910820)Varian Canada, Inc.1991-03-07
MICRO-X 80HF (K905695)Fischer Imaging Corp.1991-03-06
HFQ SERIES CONTROLS AND GENERATORS (K905799)Bennett X-Ray Corp.1991-02-26
VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY (K904169)Varian Canada, Inc.1991-02-19
VPW2877E7 X RAY POWER SUPPLY (K905855)Varian Canada, Inc.1991-02-13
G.E. DXD 325/350/350II/DXD 525/525II GENERATORS (K902986)Electromek Diagnostic Systems, Inc.1991-02-13
ANATECH X-RAY GENERATOR (K904114)Continental X-Ray Corp.1991-01-03
G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS (K902987)Electromek Diagnostic Systems, Inc.1990-12-26
G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN (K902985)Electromek Diagnostic Systems, Inc.1990-12-19
G.E. MSI 850/850II/1250 THREE PHASE GENERATORS (K902988)Electromek Diagnostic Systems, Inc.1990-12-19
KXO-80C/80D (K904043)Toshiba America Medical Systems, In.C1990-11-29
TEC 1410 (K904397)Bay Shore Medical Equipment Corp.1990-11-13
SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G (K903942)Shimadzu Medical Systems1990-10-03
VPW 2877D5, X-RAY POWER SUPPLY (K902106)Varian Assoc., Inc.1990-08-10
FUTURUS 2001 X-RAY GENERATOR (K902637)Acoma Medical Imaging, Inc.1990-08-03
MODEL# MPC (K901951)Amerisys1990-07-11
U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL (K900062)U.S. Imaging, Inc.1990-02-05
RADKOR DXG-650R (K895969)Radkor, Inc.1989-11-13
30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE (K894479)Bennett X-Ray Corp.1989-09-12
RME 325R (K893674)Fischer Imaging Corp.1989-07-20
MAMM-AIRE CP (K893681)Custom Medical Products, Ltd.1989-07-20
SENSIMAT (K892657)Transworld X-Ray Corp.1989-06-23
MULTI PULSE POWER UNIT GENERATOR (K892943)GE Medical Systems1989-05-22
GX-2000 STATIONARY X-RAY GENERATOR (K890083)Gendex Corp.1989-03-31
STAR 36 (K890066)Transworld X-Ray Corp.1989-03-28
ESP 3-PHASE X-RAY GENERATORS (K884678)Elscint, Inc.1989-01-17
CFX 625 (K883976)Fischer Imaging Corp.1988-12-13
MICRO-X 100CP (K884134)Fischer Imaging Corp.1988-10-21
RAYMAX 2100 MODELS 2130 & 2136 (K883431)Raymax Medical Corp.1988-09-12
SELDIX 325 TWO PULSE GENERATOR/CONTROL (K883154)Bay X-Ray, Inc.1988-09-06
Next →

Track IZO automatically

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