(29 days)
Not Found
No
The document describes a standard mobile C-arm X-ray system and does not mention any AI or ML capabilities in its intended use, device description, or performance studies.
No
Explanation: The device is an X-ray imaging system used for guidance and imaging during surgical interventions; it does not provide therapy.
No
The device is an X-ray imaging system used for guidance during surgical interventions, rather than for diagnosing conditions.
No
The device description explicitly states it is a "Mobile C-Arm X-Ray System" consisting of a "mobile C-arm stand with image intensifier and X-Ray unit, and a mobile View station with image processor, monitors and optionally archiving devices," indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is a Mobile C-Arm X-Ray System used for radiographic and fluoroscopic techniques in surgical interventions and procedures. This involves imaging the inside of the body using X-rays.
- Device Description: The description confirms it's an X-ray system with a C-arm, image intensifier, X-ray unit, and view station.
- Input Imaging Modality: The input is explicitly stated as X-ray.
- Anatomical Site: The anatomical sites mentioned are all internal parts of the body.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. This device operates by imaging the body directly using X-rays, not by analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The Philips BV300 Series Release 2.1 systems are intended for surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the Operating Room.
The Philips BV 300 Series Release 2.1 systems are Mobile C-Arm X-Ray Systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications. The series has been designed primarily for use in the operating theater.
The Philips BV300 Series Release 2.1 systems are intended for the same applications as the BV300 Series Release 1, i.e. surgical interventions. needing X-ray imaging and/or guidance and interventions inside and outside the Operating Room.
This includes cerebral, thoracic, abdominal, peripheral, orthopedic and vascular procedures. The systems are also suited as a back-up for a fixed vascular X-ray system.
Product codes
OXO
Device Description
The Philips BV300 Series Release 2.1 is a Mobile C-Arm X-Ray System offering Radiographic and Fluoroscopic techniques in a wide variety of applications. It has been designed primarily for use in the operating theater. All BV300 systems consist of a mobile C-arm stand with image intensifier and X-Ray unit, and a mobile View station with image processor, monitors and optionally archiving devices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
cerebral, thoracic, abdominal, peripheral, orthopedic and vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating Room
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the Philips logo, which consists of the word "PHILIPS" in bold, sans-serif font above a circular emblem. The emblem features a stylized representation of radio waves or sound waves emanating from a central point, enclosed within a circle. The overall design is simple and iconic, representing the company's focus on technology and innovation.
2 1998 SEP
Philips Medical Systems
510(k) Summary
| Company name: | Philips Medical Systems North America Company |
|---|---|
| Address: | 710 Bridgeport Avenue, Shelton, CT 06484 |
| Contact person: | Peter Altman |
| Telephone number: | 203-926-7031 |
| Prepared: | July 29, 1998 |
| Device name: | Philips BV300 Series Release 2.1 |
| Classification name: | Mobile X-Ray System |
| Common/Usual name: | Mobile C-Arm Fluoroscopic System |
| Predicate Device(s): | Philips BV300 Series (Release 1) |
Intended use:
The Philips BV300 Series Release 2.1 systems are intended for surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the Operating Room.
System description:
The Philips BV300 Series Release 2.1 is a Mobile C-Arm X-Ray System offering Radiographic and Fluoroscopic techniques in a wide variety of applications. It has been designed primarily for use in the operating theater. All BV300 systems consist of a mobile C-arm stand with image intensifier and X-Ray unit, and a mobile View station with image processor, monitors and optionally archiving devices.
Substantial equivalence Information
The BV300 Series Release 2.1 is a modification of, and substantially equivalent to, the BV300 Series Release 1, 510(k) No. K953910.
Safety Information
The BV300 Series Release 2.1 complies with the applicable portions of 21 CFR parts 1020.30/.31/.32 and voluntary safety standards, such as UL 2601. The Information for Users contains comprehensive information to insure safe and effective use.
Philips Medical Systems th Amorica Comp Shelton, Connecticut 06484-0917 Tel: (203) 926-767 Fax: (203) 929-6099
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Peter Altman Director of Regulatory Affairs Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 SHELTON CT 06484-0917
NOV 1 7 2011
Re: K982706
Trade/Device Name: Philips BV300 Series Release 2.1 Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system, mobile Regulatory Class: II Product Code: OXO Dated: August 3, 1998 Received: August 4, 1998
Dear Mr. Altman:
This letter corrects our substantially equivalent letter of September 2, 1998.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). 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. Please Note: CDRH does not evaluate information related to contact liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely Yours,
Muriel O'Hara for
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): _
444500000 1982706
Philips BV 300 Series, Release 2.1 Device Name :
Indications For Use :
The Philips BV 300 Series Release 2.1 systems are Mobile C-Arm X-Ray Systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications. The series has been designed primarily for use in the operating theater.
The Philips BV300 Series Release 2.1 systems are intended for the same applications as the BV300 Series Release 1, i.e. surgical interventions. needing X-ray imaging and/or guidance and interventions inside and outside the Operating Room.
This includes cerebral, thoracic, abdominal, peripheral, orthopedic and vascular procedures. The systems are also suited as a back-up for a fixed vascular X-ray system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vinoid le. Symm
Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number
Prescription Use
(Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)