Atlas FDA

MEVATRON KD-2

FDA 510(k) clearance K862339 · decided 1986-10-29

Clearance details

K-number
K862339
Device name
MEVATRON KD-2
Applicant
Siemens Medical Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1986-06-20
Decision date
1986-10-29
Days to decision
131 days
Clearance type
Traditional
Product code
IYE
Device class
2
Regulation number
892.5050
Medical specialty
Radiology
Advisory committee
Radiology
Location
Walnut Creek, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Mevatron K2, camera imaging system, Part Number: 1940753; Product is manufactured and dist recall (Z-2636-2011)Siemens Medical Solutions USA, Inc - Radiation Oncology2011-06-23
MEVATRONKD, camera imaging system, Part Number: 8319857; Product is manufactured and distr recall (Z-2637-2011)Siemens Medical Solutions USA, Inc - Radiation Oncology2011-06-23
MEVATRONKD-2, camera imaging system, Part Number: 8515520; Product is manufactured and dis recall (Z-2638-2011)Siemens Medical Solutions USA, Inc - Radiation Oncology2011-06-23
Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number 8515520 e recall (Z-1753-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, Mevatron KDS-2 Digital Linear Accelerator, part number 9411588 recall (Z-1754-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number 9822685 e recall (Z-1755-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, Mevatron KDS-2 Digital Linear Accelerator, part number 9822693 recall (Z-1756-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, Mevatron KD2 Digital Linear Accelerator, part number 1940753 eq recall (Z-1757-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, Mevatron M2/ Primus Mid Digital Linear Accelerator, part number recall (Z-1758-2008)Siemens Medical Solutions USA, Inc2008-09-29
Mevatron KD2 Medical Linear Accelerator, Material Number: 01940753, with control console s recall (Z-1395-2008)Siemens Medical Solutions USA, Inc2008-04-02
Siemens Mevatron Linear Accelerator Systems: KD2, K 7767, K 8067, KD, KDS and KDS2, Mevatr recall (Z-0851-2008)Siemens Medical Solutions USA, Inc2008-02-19
Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw recall (Z-0677-2008)Siemens Medical Solutions USA, Inc2008-02-14
Siemens Mevatron KDS-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 J recall (Z-0680-2008)Siemens Medical Solutions USA, Inc2008-02-14
Seimens Mevatron KD-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Ja recall (Z-0681-2008)Siemens Medical Solutions USA, Inc2008-02-14
Siemens Mevatron K-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw recall (Z-0685-2008)Siemens Medical Solutions USA, Inc2008-02-14