Product code IZO— Radiology
N 800 HF
- Classification name
- Generator, High-Voltage, X-Ray, Diagnostic
- Device class
- Class 1
- Regulation
- 21 CFR 892.1700
- Advisory panel
- Radiology
- Total cleared
- 163
- First cleared
- Most recent
Market context for product code IZO
FDA has cleared devices under product code IZO between 1976 and 1995, filed by 58 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
- 1982
- 1981
Top applicants under product code IZO
Recent clearances under product code IZO
1–100 of 163- K954666 — MPH50, MPH65, AND MPH80
- K953582 — HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
- K953831 — N 800 HF
- K952822 — SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G
- K952265 — MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR
- K950883 — POLYDOROS SX 65 AND 80
- K950694 — COMPACT-X
- K950291 — DIGITAL 625HF
- K945452 — UD 150L-F
- K945453 — UD 150L-R II
- K950040 — SII 525 APR
- K950041 — SII 360 APR
- K945731 — HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS
- K950037 — N 800 HF
- K945668 — KXO-80G
- K942731 — SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR
- K944147 — MICRO X-50 HF
- K944148 — MICRO X-30HF
- K944149 — MICRO X-80 HF
- K944150 — MICRO X-65 HF
- K943652 — VASCULAR MP X-RAY GENERATOR
- K943504 — RSX-525HF
- K942778 — MODEL VPW2877F8, MAMMO 5 POWER SUPPLY
- K942100 — MODEL TM EP HIGH VOLTAGE GENERATOR
- K934686 — MOLYBDENUM/RHODIUM FILTERS
- K940227 — SCPU X-RAY GENERATOR
- K933777 — CONCEPT ONE
- K934967 — SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR
- K935068 — RADIOGRAPHIC GENERATOR HFQ-WHIS
- K933471 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G
- K933650 — PHILIPS XRG 90 X-RAY GENERATOR SYSTEM
- K931930 — POYDOROS LX
- K933240 — POLYDOROS IS
- K931998 — LCR GENERATOR
- K930792 — RSX 30HF
- K931049 — ADVANTX SYSTEM
- K926365 — MAGMA XHF-30, XHF-40, XHF-50
- K920349 — PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR
- K920351 — PCX 650HF RADIOGRAPHIC X-RAY
- K925684 — OLYMP-X,X-RAY GENERATOR
- K924078 — POLYDOROS C
- K925105 — PHILIPS MEDIO CP FAMILY
- K925844 — PHILIPS SUPER CP FAMILY
- K923786 — POLYDOROS XS50 AND SX80
- K921875 — X-RAY CONTROL AND HI-VOLTAGE GENERATOR
- K922814 — TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT
- K922165 — ATC725, ATC525, AND AP300
- K921951 — MPG 65-80-100 X-RAY GENERATOR AND CONTROL
- K921516 — P2900 X-RAY GENERATOR
- K920730 — X-RAY HIGH VOLTAGE GENERATOR ED 125L
- K915227 — GEN-X 800/500
- K915339 — GEN-X 800/300
- K913222 — OPTIMA
- K914236 — MICRO-X 50 HF
- K914266 — MICRO-X 30 HF
- K913577 — MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR
- K913578 — MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR
- K914301 — GEN-X 800/800
- K914302 — GEN-X 800/650
- K911562 — EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR
- K913234 — VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY
- K913062 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10
- K913063 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10
- K913064 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L
- K913065 — SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L
- K912449 — MICRO-X 15 HF
- K911280 — SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B
- K910650 — SELECTOR MD (50KW AND 80 KW)
- K911339 — SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K
- K910020 — CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS
- K910820 — VPW 2877E6 X-RAY POWER SUPPLY
- K905695 — MICRO-X 80HF
- K905799 — HFQ SERIES CONTROLS AND GENERATORS
- K904169 — VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY
- K902986 — G.E. DXD 325/350/350II/DXD 525/525II GENERATORS
- K905855 — VPW2877E7 X RAY POWER SUPPLY
- K904114 — ANATECH X-RAY GENERATOR
- K902987 — G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS
- K902985 — G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN
- K902988 — G.E. MSI 850/850II/1250 THREE PHASE GENERATORS
- K904043 — KXO-80C/80D
- K904397 — TEC 1410
- K903942 — SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G
- K902106 — VPW 2877D5, X-RAY POWER SUPPLY
- K902637 — FUTURUS 2001 X-RAY GENERATOR
- K901951 — MODEL# MPC
- K900062 — U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL
- K895969 — RADKOR DXG-650R
- K894479 — 30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE
- K893674 — RME 325R
- K893681 — MAMM-AIRE CP
- K892657 — SENSIMAT
- K892943 — MULTI PULSE POWER UNIT GENERATOR
- K890083 — GX-2000 STATIONARY X-RAY GENERATOR
- K890066 — STAR 36
- K884678 — ESP 3-PHASE X-RAY GENERATORS
- K883976 — CFX 625
- K884134 — MICRO-X 100CP
- K883431 — RAYMAX 2100 MODELS 2130 & 2136
- K883154 — SELDIX 325 TWO PULSE GENERATOR/CONTROL
Data sourced from openFDA. This site is unofficial and independent of the FDA.