(26 days)
Not Found
No
The description focuses on the mechanical positioning of an X-ray tube and image intensifier, with no mention of AI/ML terms or image processing capabilities that would typically involve such technologies.
No.
The device is described as a "C-Positioner" that holds an X-ray tube and an image intensifier for diagnostic fluoroscopic procedures, not for therapeutic intervention.
No
The device, a B-400 Ceiling Mounted C-Positioner, is described as holding an X-Ray tube and an image intensifier "for the purpose of performing general purpose diagnostic fluoroscopic procedures." It facilitates imaging but does not itself analyze or interpret the images to provide a diagnosis.
No
The device description clearly describes a physical, ceiling-mounted C-Positioner with motorized movement, intended to hold an X-Ray tube and image intensifier. This is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The B-400 Ceiling Mounted C-Positioner is a mechanical device designed to hold and position an X-ray tube and image intensifier. Its purpose is to facilitate the acquisition of diagnostic images within the body, not to analyze samples outside the body.
- Intended Use: The intended use clearly states it's "To support the Diagnostic Source Assembly & Image Receptor used in performing general-purpose diagnostic fluoroscopic procedures." This describes a device used in the process of generating images, not analyzing biological samples.
Therefore, based on the provided information, the B-400 Ceiling Mounted C-Positioner is a radiological positioning device, not an IVD.
N/A
Intended Use / Indications for Use
To support the Diagnostic Source Assembly & Image Receptor used in performing general-purpose diagnostic fluoroscopic procedures.
Product codes
90JAA
Device Description
The B-400 Ceiling Mounted C-Positioner is a device intended to hold an X-Ray tube and an image intensifier 180° apart in a "C" configuration for the purpose of performing general purpose diagnostic fluoroscopic procedures.
The C-Positioner allows variable positioning of the X-Ray tube/Image Intensifier from +145 degrees Left Anterior Oblique (LAO) to 55 degrees Left Posterior Oblique (LPO). The device will maintain isocenter throughout its full range of motorized movement. The entire assembly is mounted to a set of ceiling rails.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K970947, K915592, K880527, K923813
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
ﻪ ..
1990053 OMEGA MEDICAL IMAGING, INC. -B-400
January 6, 1999
510 (k) Summary
Submitter: Omega Medical Imaging, Inc., 675 Hickman Circle, Sanford, FL 32771 Douglas M. Coon, President.
Device Name: B-400 Isocentric Ceiling Mounted C-Positioner.
Classification Name: System, Fluoroscopic, Image Intensified, All Types,
Common/Usual Name: C-Arm
Substantially Equivalent Devices: Fisher's PEGASUS Ceiling Mounted Cardiac Positioner. Fisher's ARIEL Ceiling Mounted C-Arm, Fisher's CPS Ceiling Mounted Imaging System, Philip's INTEGRIS HM 3000 and Omega B-350 Ceiling Mounted Positioner.
Description: The B-400 Ceiling Mounted C-Positioner is a device intended to hold an X-Ray tube and an image intensifier 180° apart in a "C" configuration for the purpose of verforming general purpose diagnostic fluoroscopic procedures.
The C-Positioner allows variable positioning of the X-Ray tube/Image Intensifier from +145 degrees Left Anterior Oblique (LAO) to 55 degrees Left Posterior Oblique (LPO). The device will maintain isocenter throughout its full range of motorized movement. The entire assembly is mounted to a set of ceiling rails.
Intended Use: To support the Diagnostic Source Assembly & Image Receptor used in performing general-purpose diagnostic fluoroscopic procedures.
Summary of Technological Characteristics: The B-400 Ceiling Mounted C-Positioner has the same technological characteristics as the predicate devices. The B-400 and the predicate devices all have the same intended use: to support the X-Ray tube (Diagnostic Source Assembly) and the Image Intensifier (Image Receptor) directly opposite each other with some variation in the distance from the X-Ray tube to the Image Receptor (SID), for diagnostic fluoroscopic procedures. The only differences in the devices are market driven variables such as the SID, arc rotation for different procedures, and the ability to rotate about the ceiling axis. The above devices are essentially all ceiling suspended C-Arms with some variations, depending on user preference. The Omega B-400 Ceiling Mounted C-Positioner (C-Arm) is substantially equivalent to the predicate devices as well as any number of other Cciling Mountcd C-Arms that have been legally marketed in the U.S. for many years.
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OMEGA MEDICAL IMAGING, INC. _ _ B-400
SUBSTANTIAL EQUIVALENCE COMPARISON
| Device Model: | Omega B400 | Omega B350 | Fisher Pegasus | Fisher Ariel | Philips Integras
HM 3000 |
|------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| 510(k):
Classification: | Submitted Herein
90JAA | K970947
90JAA | K915592
90JAA | K880527
90JAA | K923813
90JAA |
| Description: | Ceiling Mounted
'C' Positioner | Ceiling Mounted
'C' Positioner | Ceiling Mounted
Cardiac Positioner | Ceiling Mounted
Fluoroscopy C-Arm | Ceiling Mounted
C-Arm Portion |
| Intended Use: | 'C'-Arm to support
X-Ray Diagnostic
Source Assembly
& Image Receptor
for Fluoroscopy | 'C'-Arm to support
X-Ray Diagnostic
Source Assembly
& Image Receptor
for Fluoroscopy | 'C'-Arm to support
X-Ray Diagnostic
Source Assembly
& Image Receptor
for Fluoroscopy | 'C'-Arm to support
X-Ray Diagnostic
Source Assembly
& Image Receptor
for Fluoroscopy | 'C'-Arm to support
X-Ray Diagnostic
Source Assembly
& Image Receptor
for Fluoroscopy |
| Source to Image
Distance (SID): | Variable
46" to 56" | Variable
32"to 42" | Variable
34" to 50" | Not available | Variable
86.5 to 116.6 cm |
| Rotation about
Vertical Axis: | +/- 180° | Fixed at
lateral center | +45°/-90° | +90°/-90° | +90°/-90° |
| Arc Rotation: | +145°/-55° | +60°/-30°
(30° LAO to 120° LPO) | +30°/-90° | +45°/-45° | +70°/ 90°
LAO/RAO |
| C-Arm Radius
(Throat): | 36" | 43" | 46½" | Not available | 36" |
| C-Arm Width
O.D. Dimension: | 78" | 89" | 91" | Not available | Not available |
DISCUSSION: All of the devices listed above have the same intended use: to support the X-Ray tube (Diagnostic Source Assembly) and the Image Intensifier (Image Receptor) directly opposite each other with some variation in the distance from the X-Ray tube to the Image Receptor (SIP), for diagnostic fluoroscopic procedures. The only differences in the above devices are market driven variables such as the SID, arc rotation for different procedures, and the ability to rotate about the ceiling axis. The above devices are essentially all ceiling suspended C-Arms with some variations depending on user preference. The Omega B-400 Ceiling Mounted C-Positioner (C-Arm) has the same intended use & technological characteristics as the above listed devices as well as any number of other Ceiling Mounted C-Arms that have been legally marketed in the U.S. for many years.
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2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1999
Douglas Coon President & CEO Omega Medical Imaging Incorporated 675 Hickman Circle Sanford, FL 32771
Re:
K990055 B-400 Ceiling Mounted Positioner Dated: January 6, 1999 Received: January 7, 1999 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA
Dear Mr. Coon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you micht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Model B-400 C-Arm ( C-Positioner)
Indications For Use:
Device Intended Use
This device is intended to support the X-Ray Diagnostic Source Assembly and the Image Receptor. It is not designed nor intended to be used in any General Purpose X-Ray System.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Segner
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological I 510(k) Number
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
OR
Over-The-Counter Use
(Optional Format 1-2-96) Page 9