Atlas FDA

JAC

18 FDA 510(k) clearances · Product code

73 daysmedian time to decision
231 days90th percentile
18clearances measured

FDA profile

Official device name
System, X-Ray, Film Marking, Radiographic
Device class
Class I (low risk)
Regulation
21 CFR 892.1640
Medical specialty
Radiology
Adverse events (MAUDE)
2012: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
DIGITAL I.D. CAMERA (K942883)Miles Inc., Agfa Division1994-09-30
CT/MRI TOPOGRAPHIC MARKER (K930752)I.Z.I. Corp.1993-11-19
FUJI EC ID CAMERA (K932357)Fujifilm Medical System U.S.A., Inc.1993-07-26
SOLSTICE XRAY RING MARKER PAD (K925892)Solstice Corp.1993-05-18
ADMARK (K923533)Planmeca USA, Inc.1993-03-04
KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L (K926404)Eastman Kodak Company1993-03-04
RADIOGRAPHIC FILM MARKETING SYSTEM (K924345)Fischer Imaging Corp.1992-11-27
BENNETT X-RAY ID PLUS (K925332)Bennett X-Ray Technologies1992-11-27
KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE (K920031)Eastman Kodak Company1992-02-12
KODAK MIN-R IDENTIFICATION CAMERA (K915088)Eastman Kodak Company1991-12-02
RADIOGRAPHIC FILM MARKING SYSTEM (K913478)Lorad Medical Systems, Inc.1991-10-15
X-MARX (K911873)Macbrud Corp. Medical Div.1991-07-19
DU PONT IDENTIFICATION CAMERA (K910354)Dupont Medical Products1991-03-29
KODAK PORTABLE IDENTIFICATION CAMERA (K890467)Eastman Kodak Company1989-02-16
X-RAY MARKER (K882519)Karlin Technology, Inc.1988-08-09
KODAK X-OMATIC IDENT. CAMERA, MODELS 2 AND 2L (K870565)Eastman Kodak Company1987-02-26
KODAK X-OMATIC IDENTIFICATION CAMERA DIGITAL (K870701)Eastman Kodak Company1987-02-26
RADIOLOGICAL MARKING PEN (K852160)Truett Laboratories, Inc.1985-07-18

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