Atlas FDA

EAP

42 FDA 510(k) clearances · Product code

70 daysmedian time to decision
220 days90th percentile
42clearances measured

FDA profile

Official device name
Unit, X-Ray, Intraoral
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1810
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2004: 29 · 2005: 2 · 2006: 9 · 2007: 6 · 2008: 18 · 2026: 306
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MEDICAL IMAGE PROCESSING UNIT (K113360)Humanray Co,Ltd2012-02-07
PROVU (TM) DENTAL X-RAY SYSTEM (K102573)Advanced Image Science, Inc.2011-06-30
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (K093453)Schick Technologies, Inc.2009-11-30
DENTRON SENSOR (K080738)Dentron Systems, LLC2008-05-13
THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) (K052422)Flow X-Ray Corp.2005-09-27
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (K041385)Schick Technologies, Inc.2004-06-07
HELIODENT DS (K960819)Pelton & Crane Co.1996-03-29
ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM (K960028)Dentsply Intl.1996-03-01
ATLANTIS (K953936)Trophy Radiologie1995-12-28
EXPLOR-X (AZTEH) HF (K954565)Chicago X-Ray Systems, Inc.1995-10-27
LUMIX 70B (K951734)Emix U.S.A., Inc.1995-07-20
TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY (K950533)Trophy Radiologie1995-06-30
TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY (K950532)Trophy Radiologie1995-04-19
AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER (K950667)Chicago X-Ray Systems, Inc.1995-04-06
HELIODENT MD (K950030)Pelton & Crane Co.1995-02-03
RADWORKS (K934645)Radworks Corp.1994-08-17
ORTHOPHOS 3/ ORTHOPHOS 3C (K936068)Pelton & Crane Co.1994-07-29
COMPUTED ORAL RADIOLOGY SYSTEM (K933455)Schick Technologies, Inc.1994-01-31
INTREX VSK INTERORAL DENTAL X-RAY UNIT (K931486)Keystone X-Ray, Inc.1993-11-23
YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY (K931717)Kaycor Intl., Ltd.1993-09-20
INTREX INTERORAL DENTAL X-RAY UNIT (K930925)Keystone X-Ray, Inc.1993-07-13
IMAGE-X 70 INTRAORAL X-RAY SYSTEM (K930761)Afp Imaging Corp.1993-05-25
HEALTHPAK X-RAY SOX BARRIERS (K923307)Healthpak, Inc.1993-01-21
PANORAMIC MODEL X-CALIBER X-RAY (K900681)Belmont Equipment Corp.1990-05-23
TRIMODE SP DENTAL INTRA ORAL X-RAY (K896963)Tempo Technology, Inc.1990-01-22
MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE (K896024)Mdt Diagnostic Co.1990-01-22
VARIABLE KV INTREX VSK 60 - 90 KVP (K883354)Keystone X-Ray, Inc.1988-12-21
MINIM-X 2001-CIAS & MINIM-X 2002-CIAS (K882379)Dentomar, Inc.1988-09-09
NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY (K861328)Belmont Equipment Corp.1986-04-24
BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD (K852019)Belmont Equipment Corp.1985-06-05
ACURAY 071A DENTAL INTRAORAL X-RAY (K834279)Belmont Equipment Corp.1983-12-29
INTREX (K833241)Pennwalt Corp.1983-10-28
ACURACY 071, DENTAL, INTRAORAL-X-RAY (K832065)Belmont Equipment Corp.1983-09-12
XR-710 (K800063)Pennwalt Corp.1980-03-03
PORTARAY (K792535)Siemens Corp.1980-01-28
RAFLEX 70 (K792437)Mdt Corp., Inc.1980-01-09
DENTIX DENTAL X-RAY UNIT (K792307)Precise Optics1980-01-09
DENTAL XERORADIOGRAPHY (K791014)Xerox Medical Systems1979-09-04
GE-700 INTRA ORAL X-RAY SYSTEM (K781630)General Electric Co.1978-12-04
X-RAY SYSTEM FOR DENTAL APPLICATION (K772184)General Electric Co.1977-12-22
X-RAY TUBE - PANOBEAM (K770345)Thoro-Ray, Inc.1977-03-08
X-RAY UNIT, DENTAL DIAGNOSTIC (K760323)The S. S. White Co.1976-08-03

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