FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
12553–12576 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 30, 1991
HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST
K913757 · KPR
Hologic, Inc.
Radiology · 70d
Cleared Oct 30, 1991
CARDIOFOCAL COLLIMATOR
K914179 · KPS
Siemens Gammasonics, Inc.
Radiology · 42d
Cleared Oct 30, 1991
GEN-X 800/800
K914301 · IZO
Swissray Finatech, Inc.
Radiology · 35d
Cleared Oct 30, 1991
GEN-X 800/650
K914302 · IZO
Swissray Finatech, Inc.
Radiology · 35d
Cleared Oct 28, 1991
VISION (NUCLEAR MEDICINE COMPUTER)
K912573 · KPS
Summit Nuclear
Radiology · 139d
Cleared Oct 28, 1991
TETLEY PATIENT ADMINISTRATION SET
K913416 · IYT
Tetley Medical , Ltd.
Radiology · 89d
Cleared Oct 24, 1991
EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR
K911562 · IZO
Continental X-Ray Corp.
Radiology · 199d
Cleared Oct 24, 1991
DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480
K911584 · IYO
Pie Medical Equipment B.V.
Radiology · 199d
Cleared Oct 23, 1991
INVENTOR RT/EXPLORER TRAUMA UNIT
K911563 · IYB
Continental X-Ray Corp.
Radiology · 198d
Cleared Oct 23, 1991
SWEMAC REISON BIPLANAR 300
K911739 · OXO
Seemac Reison AB Co.
Radiology · 189d
Cleared Oct 23, 1991
CIRRUS GAMMA CAMERA
K913471 · KPS
Adac Laboratories
Radiology · 79d
Cleared Oct 23, 1991
MOBILE X-RAY SYSTEM
K913525 · OXO
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared Oct 23, 1991
MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM
K913630 · KPS
Siemens Gammasonics, Inc.
Radiology · 69d
Cleared Oct 21, 1991
MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM
K912180 · IZX
Instrumentarium Imaging, Inc.
Radiology · 158d
Cleared Oct 21, 1991
MODEL #SCT-32 AUTO QUADRATURE SPINE COIL TRANSPORT
K913441 · LNH
Mri Devices Corp.
Radiology · 80d
Cleared Oct 21, 1991
CARDIO 500
K913754 · LLZ
Kontron Elektronik GmbH
Radiology · 61d
Cleared Oct 17, 1991
MODULEX RTP SYSTEM
K913017 · KPQ
Computerized Medical Systems, Inc.
Radiology · 100d
Cleared Oct 15, 1991
COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED
K911750 · IYE
Medical Instrumentation & Diagnostics...
Radiology · 180d
Cleared Oct 15, 1991
PHILIPS ANGIOPRO
K911888 · IZP
Philips Medical Systems North...
Radiology · 169d
Cleared Oct 15, 1991
ULTRASOUND STETHOSCOPE(R) INTRADOP(R)
K912033 · JAF
Medadonics, Inc.
Radiology · 159d
Cleared Oct 15, 1991
GYROVIEW-HR
K913029 · JAK
Philips Medical Systems, Inc.
Radiology · 98d
Cleared Oct 15, 1991
RADIOGRAPHIC FILM MARKING SYSTEM
K913478 · JAC
Lorad Medical Systems, Inc.
Radiology · 70d
Cleared Oct 10, 1991
MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130
K912382 · IXQ
Continental X-Ray Corp.
Radiology · 134d
Cleared Oct 09, 1991
HEMISPHERE MULTIPLANE ENDORECTAL PROBE
K911043 · ITX
Pie Medical Equipment B.V.
Radiology · 215d