FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIMRITE VERIFICATION AND SIMULATION SYSTEM
K Number: K885081
·
Decision Mar 22, 1989
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
69
Applicant Total
2
Review Days
103
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SIMRITE VERIFICATION AND SIMULATION SYSTEM
- K Number
- K885081
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5840
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Haynes Radiation Ltd., Inc.
- Date Received
- December 9, 1988
- Decision Date
- March 22, 1989
- Product Code
- KPQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPQ | System, Simulation, Radiation Therapy | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPQ), ordered by most recent decision date.
ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
FDA 510(k)
FDA Class 2
·Radiology
ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
FDA 510(k)
FDA Class 2
·Radiology
RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER
FDA 510(k)
FDA Class 2
·Radiology
ONCENTRA SIMULATION 2.3
FDA 510(k)
FDA Class 2
·Radiology
IKOENGELO, VERSION 2
FDA 510(k)
FDA Class 2
·Radiology
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Haynes Radiation Ltd., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K834281 | RAD II SIMULATOR | Dec 29, 1983 | Substantially Equivalent |