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Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
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Physical Medicine
Review Panel
Radiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
FCD
Barium Enema Kit
1
Product Code
ITZ
Assembly, Tube Housing, X-Ray, Therapeutic
2
Product Code
IWA
Source, Wire, Iridium, Radioactive
2
Product Code
IWB
System, Radiation Therapy, Radionuclide
2
Product Code
IWD
Device, Beam Limiting, Teletherapy, Radionuclide
2
Product Code
IWE
Monitor, Patient Position, Light-Beam
1
Product Code
K
15
2303
CT Sim Laser System
1
Cleared 510(K)
K
97
3162
DUAL RADIATION TARGETING SYSTEM DRTS DRAPE
1
Cleared 510(K)
K
95
5236
GREEN TEC-2100
1
Cleared 510(K)
K
95
4414
CENTRALITE BACKPOINTER
1
Cleared 510(K)
K
95
0293
TEC-2110 GREEN LASER MODEL MT-HNG
1
Cleared 510(K)
K
95
0112
CENTRALITE(R)-DLL SERIES
1
Cleared 510(K)
K
95
1601
MED-TEC STRING RETICLE TRAY
1
Cleared 510(K)
K
94
3802
HP BACK POINTER SYSTEM
1
Cleared 510(K)
K
94
3381
LASER ALIGNMENT TOOL
1
Cleared 510(K)
K
94
1169
TEC 2101 (MODEL MT-HPLGD)
1
Cleared 510(K)
K
93
5760
TEC 2100 (MODEL MT-LPLGD)
1
Cleared 510(K)
K
93
4519
RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM
1
Cleared 510(K)
K
93
1974
AZ 92
1
Cleared 510(K)
K
93
0294
PATPOS GREEN
1
Cleared 510(K)
K
93
0295
PATPOS COMPACT
1
Cleared 510(K)
K
93
0296
PATPOS RED
1
Cleared 510(K)
K
92
3619
ACCULITE SSL
1
Cleared 510(K)
K
90
4127
A2J TELEMETER
1
Cleared 510(K)
K
90
4753
DIOLASE
1
Cleared 510(K)
K
89
3398
CENTRALITE BACKPOINTER
1
Cleared 510(K)
K
88
0981
A2J MZ 44 B TYPE
1
Cleared 510(K)
K
87
2894
A2J MZ 44 LASER LIGHT FOR POSITIONING
1
Cleared 510(K)
K
87
2841
ACCULITE
1
Cleared 510(K)
K
87
2489
CENTRALITE
1
Cleared 510(K)
K
86
0472
NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS
1
Cleared 510(K)
K
80
1541
WALL MOUNTED LASER POSITIONING DEVICE
1
Cleared 510(K)
K
80
0489
LASER BACKPOINTER ASSEMBLY, MOD. 01-2487
1
Cleared 510(K)
K
80
0223
PATIENT POSITIONING SYSTEM 1D OR 2D
1
Cleared 510(K)
IWF
Needle, Isotope, Gold, Titanium, Platinum
2
Product Code
IWG
Seed, Isotope, Gold, Titanium, Platinum
2
Product Code
IWH
Source, Teletherapy, Radionuclide
1
Product Code
IWI
Source, Isotope, Sealed, Gold, Titanium, Platinum
2
Product Code
IWJ
System, Applicator, Radionuclide, Manual
1
Product Code
IWK
Cyclotron, Medical
2
Product Code
IWL
System, Radiation Therapy, Neutron, Medical
2
Product Code
IWM
Synchrotron, Medical
2
Product Code
IXI
Block, Beam-Shaping, Radiation Therapy
2
Product Code
IYC
Generator, Orthovoltage, Therapeutic X-Ray
2
Product Code
IYD
Generator, Low Voltage, Therapeutic X-Ray
2
Product Code
IYE
Accelerator, Linear, Medical
2
Product Code
IYG
Betatron, Medical
2
Product Code
IYH
Generator, Dermatological (Grenz Ray), Therapeutic X-Ray
2
Product Code
IYI
Collimator, Orthovoltage, Therapeutic X-Ray
2
Product Code
IYJ
Collimator, Low Voltage, Therapeutic X-Ray
2
Product Code
IYK
Collimator, High Voltage, Therapeutic X-Ray
2
Product Code
IYL
Collimator, Dermatological, Therapeutic X-Ray
2
Product Code
JAD
System, Therapeutic, X-Ray
2
Product Code
JAE
Microtron, Medical
2
Product Code
JAI
Couch, Radiation Therapy, Powered
2
Product Code
JAQ
System, Applicator, Radionuclide, Remote-Controlled
2
Product Code
KPQ
System, Simulation, Radiation Therapy
2
Product Code
KPZ
Generator, High Voltage, X-Ray, Therapeutic
2
Product Code
KQA
Device, Beam Limiting, X-Ray, Therapeutic
2
Product Code
KXK
Source, Brachytherapy, Radionuclide
2
Product Code
LHN
System, Radiation Therapy, Charged-Particle, Medical
2
Product Code
MUJ
System, Planning, Radiation Therapy Treatment
2
Product Code
MWW
Accessory - Film Dosimetry System
2
Product Code
NMP
Needle, Isotope, Reprocessed
2
Product Code
NZT
Dosimeter, Ionizing Radiation, Implanted
2
Product Code
OIN
Prostate Seeding Kit
2
Product Code
ONL
Conformal Brachytherapy Source
2
Product Code
OVB
Hydrogel Spacer
2
Product Code
PCT
Prostate Immobilizer Rectal Balloon
2
Product Code
RGC
X-Ray Field Indicator Light (Laser)
1
Product Code
Subpart G—Miscellaneous Devices
CFR Sub-Part
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 25 January 2026 at 3:41 am
RA
/
subpart-f—therapeutic-devices
/
IWE
/
K872489
View Source
CENTRALITE
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K872489
510(k) Type
Traditional
Applicant
DIACOR, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/15/1987
Days to Decision
22 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart F—Therapeutic Devices
FCD
Barium Enema Kit
ITZ
Assembly, Tube Housing, X-Ray, Therapeutic
IWA
Source, Wire, Iridium, Radioactive
IWB
System, Radiation Therapy, Radionuclide
IWD
Device, Beam Limiting, Teletherapy, Radionuclide
IWE
Monitor, Patient Position, Light-Beam
K
15
2303
CT Sim Laser System
K
97
3162
DUAL RADIATION TARGETING SYSTEM DRTS DRAPE
K
95
5236
GREEN TEC-2100
K
95
4414
CENTRALITE BACKPOINTER
K
95
0293
TEC-2110 GREEN LASER MODEL MT-HNG
K
95
0112
CENTRALITE(R)-DLL SERIES
K
95
1601
MED-TEC STRING RETICLE TRAY
K
94
3802
HP BACK POINTER SYSTEM
K
94
3381
LASER ALIGNMENT TOOL
K
94
1169
TEC 2101 (MODEL MT-HPLGD)
K
93
5760
TEC 2100 (MODEL MT-LPLGD)
K
93
4519
RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM
K
93
1974
AZ 92
K
93
0294
PATPOS GREEN
K
93
0295
PATPOS COMPACT
K
93
0296
PATPOS RED
K
92
3619
ACCULITE SSL
K
90
4127
A2J TELEMETER
K
90
4753
DIOLASE
K
89
3398
CENTRALITE BACKPOINTER
K
88
0981
A2J MZ 44 B TYPE
K
87
2894
A2J MZ 44 LASER LIGHT FOR POSITIONING
K
87
2841
ACCULITE
K
87
2489
CENTRALITE
K
86
0472
NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS
K
80
1541
WALL MOUNTED LASER POSITIONING DEVICE
K
80
0489
LASER BACKPOINTER ASSEMBLY, MOD. 01-2487
K
80
0223
PATIENT POSITIONING SYSTEM 1D OR 2D
IWF
Needle, Isotope, Gold, Titanium, Platinum
IWG
Seed, Isotope, Gold, Titanium, Platinum
IWH
Source, Teletherapy, Radionuclide
IWI
Source, Isotope, Sealed, Gold, Titanium, Platinum
IWJ
System, Applicator, Radionuclide, Manual
IWK
Cyclotron, Medical
IWL
System, Radiation Therapy, Neutron, Medical
IWM
Synchrotron, Medical
IXI
Block, Beam-Shaping, Radiation Therapy
IYC
Generator, Orthovoltage, Therapeutic X-Ray
IYD
Generator, Low Voltage, Therapeutic X-Ray
IYE
Accelerator, Linear, Medical
IYG
Betatron, Medical
IYH
Generator, Dermatological (Grenz Ray), Therapeutic X-Ray
IYI
Collimator, Orthovoltage, Therapeutic X-Ray
IYJ
Collimator, Low Voltage, Therapeutic X-Ray
IYK
Collimator, High Voltage, Therapeutic X-Ray
IYL
Collimator, Dermatological, Therapeutic X-Ray
JAD
System, Therapeutic, X-Ray
JAE
Microtron, Medical
JAI
Couch, Radiation Therapy, Powered
JAQ
System, Applicator, Radionuclide, Remote-Controlled
KPQ
System, Simulation, Radiation Therapy
KPZ
Generator, High Voltage, X-Ray, Therapeutic
KQA
Device, Beam Limiting, X-Ray, Therapeutic
KXK
Source, Brachytherapy, Radionuclide
LHN
System, Radiation Therapy, Charged-Particle, Medical
MUJ
System, Planning, Radiation Therapy Treatment
MWW
Accessory - Film Dosimetry System
NMP
Needle, Isotope, Reprocessed
NZT
Dosimeter, Ionizing Radiation, Implanted
OIN
Prostate Seeding Kit
ONL
Conformal Brachytherapy Source
OVB
Hydrogel Spacer
PCT
Prostate Immobilizer Rectal Balloon
RGC
X-Ray Field Indicator Light (Laser)
Subpart G—Miscellaneous Devices
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
subpart-f—therapeutic-devices
/
IWE
/
K872489
View Source
CENTRALITE
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K872489
510(k) Type
Traditional
Applicant
DIACOR, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/15/1987
Days to Decision
22 days