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Panels › Radiology › Product code JAC · Class 1

System, X-Ray, Film Marking, Radiographic

Regulation 892.1640

0510(k)s in 12 months (18 all time)
1recalls in 12 months (16 all time)
0recalls that name a 510(k)
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Top companies in JAC

Company510(k)sRecalls
Beekley Corporation08
Eastman Kodak Company60
AGFA Corp.04
GE Healthcare, LLC03
Solstice Corp.11
Bennett X-Ray Technologies10
Dupont Medical Products10
Fischer Imaging Corp.10
Fujifilm Medical System U.S.A., Inc.10
I.Z.I. Corp.10
DateFirm and productCodeLinked 510(k)
Oct 22, 2026Solstice Corporation
Xact mole marker for mammography Model/Catalog Number: M15RM
Open, Classified		 JACNone listed
Jun 13, 2018Beekley Corporation
TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.
Terminated		 JACNone listed
Jun 13, 2018Beekley Corporation
S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.
Terminated		 JACNone listed
Jun 13, 2018Beekley Corporation
O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
Terminated		 JACNone listed
May 8, 2017Beekley Corporation
Beekley Medical 0-SPOT Mammography Skin Markers REF 652
Terminated		 JACNone listed
Feb 27, 2013GE Healthcare, LLC
GE Healthcare Definium 5000/5220493-2 X-Ray System
Terminated		 JACNone listed
Feb 27, 2013GE Healthcare, LLC
GE Healthcare Definium 5000 / 5220493 X-Ray System
Terminated		 JACNone listed
Feb 26, 2013GE Healthcare, LLC
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Terminated		 JACNone listed
Jul 31, 2012Beekley Corporation
Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas of concern or pain
Terminated		 JACNone listed
Jul 31, 2012Beekley Corporation
Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
Terminated		 JACNone listed
Jul 31, 2012Beekley Corporation
Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
Terminated		 JACNone listed
Jul 31, 2012Beekley Corporation
Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
Terminated		 JACNone listed
Apr 11, 2006AGFA Corp.
Radiomat SG, 11x14, Medical Screen Film, X-ray Film, 100 Sheet Box and 14x17, 100 Sheet Box
Terminated		 JACNone listed
Apr 11, 2006AGFA Corp.
Curix Ultra UV-L Plus, Medical Screen Film, X-ray Film, 14x17, 100 Sheet Box
Terminated		 JACNone listed
Apr 11, 2006AGFA Corp.
Cronex 10T, 14x17, Medical Screen Film, X-ray Film, 100 Sheet Box
Terminated		 JACNone listed
Feb 4, 2006AGFA Corp.
Agfa Cronex 10T Radiographic film
Terminated		 JACNone listed

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