Home › Device types › JAC
System, X-Ray, Film Marking, Radiographic
FDA product code JAC · Class 1 · Radiology
256
Registered devices
24
Adverse events
15
Recalls
18
510(k) clearances
Devices with this code
Clearline — Jessop Precision Products Inc.CT-SPOT — Beekley CorporationLocalizers — Beekley CorporationCT-SPOT — Beekley CorporationClearmarks — Jessop Precision Products Inc.Clearmarks — Jessop Precision Products Inc.N-SPOT — Beekley CorporationBeautyLine — Jessop Precision Products Inc.TL-HEX TRUELOK HEXAPOD SYSTEM — ORTHOFIX SRLComfortMark — Jessop Precision Products Inc.A-SPOT — Beekley CorporationR-SPOT — Beekley CorporationDentalMark — Jessop Precision Products Inc.Visionline Kids — Jessop Precision Products Inc.OrthoSPOTS Packets — Beekley CorporationTomomark — Jessop Precision Products Inc.Xact — Solstice CorporationTomomark — Jessop Precision Products Inc.Suremark — Jessop Precision Products Inc.Localizers — Beekley CorporationKingmark Assembly — Brainlab SECTMark — Jessop Precision Products Inc.PortalMark — Jessop Precision Products Inc.Visionline Kids — Jessop Precision Products Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-06-13 | Beekley Corporation | There is a potential for imaging artifact to mimic calcifications on patient's mammograms |
| 2018-06-13 | Beekley Corporation | There is a potential for imaging artifact to mimic calcifications on patient's mammograms |
| 2018-06-13 | Beekley Corporation | There is a potential for imaging artifact to mimic calcifications on patient's mammograms |
| 2017-05-08 | Beekley Corporation | Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels |
| 2012-09-26 | GE Healthcare, LLC | When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) |
| 2012-09-26 | GE Healthcare, LLC | When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) |
| 2012-08-03 | GE Healthcare, LLC | GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as |
| 2012-07-09 | Beekley Corporation | Digital Skin Mammography Marker separating from the backing of the spot material |
| 2012-07-09 | Beekley Corporation | Digital Skin Mammography Marker separating from the backing of the spot material |
| 2012-07-09 | Beekley Corporation | Digital Skin Mammography Marker separating from the backing of the spot material |
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