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12 devices found
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sorted by relevance
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Manufacturer: Zap Surgical Systems, Inc.
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Device · Manufacturer · Authorizations
Verified
Status
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Registry
Class
ZAP-X Radiosurgery System (ZAP-X)
Zap Surgical Systems, Inc.
·
,
United States
Class II
CE/MDR
FDA 510(k)
K250392
Active
+1
authorizations
Active
CE MDR
510(k)
EUDAMED
510(k)
GUDID
II
PinZ Patient Immobilizer 465830
Zap Surgical Systems, Inc.
·
,
United States
Class II
GUDID
on market
None
GUDID
II
Kit, Container, Head Immobilizer 300154
Zap Surgical Systems, Inc.
·
,
United States
Class II
GUDID
on market
None
GUDID
II
ZAP-Axon Treatment Planning System 300157
Zap Surgical Systems, Inc.
·
,
United States
Class II
GUDID
on market
None
GUDID
II
DoseGuard 300158
Zap Surgical Systems, Inc.
·
,
United States
Class II
GUDID
on market
None
GUDID
II
Kit, Container, Fixation Pins, Immobilizer 300159
Zap Surgical Systems, Inc.
·
,
United States
Class II
GUDID
on market
None
GUDID
II
Zap-X MV Imager 300153
Zap Surgical Systems, Inc.
·
,
United States
Class II
GUDID
on market
None
GUDID
II
Zap-X Treatment Planning Software 300152
Zap Surgical Systems, Inc.
·
,
United States
Class II
GUDID
on market
None
GUDID
II
Zap-X Treatment Delivery Software 300151
Zap Surgical Systems, Inc.
·
,
United States
Class II
GUDID
on market
None
GUDID
II
Zap-X Radiosurgery System
Zap Surgical Systems
·
,
FDA registration: United States
Class II
FDA 510(k)
K171804
Active
Cleared 21 Sep 2017
Active
510(k)
510(k)
II
2 variants
Zap-X Radiosurgery System
K183698
Zap-X Radiosurgical System
Open recall
Zap Surgical Systems, Inc.
·
,
United States
Class II
FDA 510(k)
K211663
Active
Cleared 29 Jul 2021
Active
510(k)
510(k)
II
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