(21 days)
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No
The document describes a standard Mini C-Arm Fluoroscopic Imaging System with typical hardware specifications and operating system. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or other sections. The focus is on the imaging hardware and basic processing capabilities.
No
This device is an imaging system designed for visualization, not for directly treating or curing a medical condition.
Yes
The "Intended Use / Indications for Use" states that the device is "designed to provide physicians with general fluoroscopic visualization of a patient," which is a form of diagnostic imaging.
No
The device description clearly outlines significant hardware components including an x-ray tube, image intensifier, digital video camera, processor, storage drives, display, and input devices, indicating it is a physical imaging system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "general fluoroscopic visualization of a patient." This involves imaging the inside of the body using X-rays.
- Device Description: The description details a "Mini C-Arm Fluoroscopic Imaging System" with components like an X-ray tube, image intensifier, and display. These are all characteristic of medical imaging devices used for visualizing internal structures.
- Input Imaging Modality: The input modality is "Fluoroscopic X-Ray," which is a form of medical imaging.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to be used in vitro (outside the body) to examine these types of samples.
In summary, the Fluoroscan InSight is a medical imaging device used for visualizing the inside of a patient's body, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including, but not limited to surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations.
Product codes (comma separated list FDA assigned to the subject device)
90 JAA
Device Description
The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Fluoroscopic X-Ray
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
physicians / surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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F. 510(k) Summary
F.1 Manufacturing Establishment and Contact Information
F.1.1 Manufacturer Name and Address:
Hologic, Inc. 35 Crosby Drive Bedford, MA 01730
F.1.2 Establishment Registration Number:
1221300
F.1.3 Name, Title, and Telephone Number of Contact:
Daniel F. Phelan Senior Regulatory Affairs Specialist (781) 999-7300
F.2 Device Identification
-
F.2.1 Device Trade Name:
Fluoroscan InSight Mini C-Arm Fluoroscopic Imaging System -
F.2.2 Common / Usual Name:
Fluoroscopic Imaging System -
F.2.3 Proposed Intended Use:
The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including, but not limited to surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations.
F.3 Device Classification
-
F.3.1 Classification:
Class II -
F.3.2 Classification Name and Rule:
Image-Intensified Fluoroscopic X-Ray System, 21 CFR 892.1650 -
F.3.3 Classification Panel:
Radiology -
F.3.4 Product Code:
90 JAA -
F.3.5 Predicate Device
510(k) No.: K974058
Trade Name: FS IV Mini C- Arm System
January 12, 1998. SE Date:
Manufacturer: Hologic, Inc.
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F.4 Substantial Equivalence
| Fluoroscan Premier(FS-IV) | Fluoroscan InSight | |
|---|---|---|
| Image: Fluoroscan Premier(FS-IV) | Image: Fluoroscan InSight | |
| 510(k) Number | K974058 | Same |
| Indications for Use | Mini C-Arm Fluoroscopic Imaging System | |
| designed to provide physicians with general | ||
| fluoroscopic visualization of a patient, | ||
| including, but not limited to surgical | ||
| orthopedic and podiatry use, critical and | ||
| emergency care procedures, and light | ||
| anatomy imaging situations | Same | |
| Dimensions (HxWxD) | 60" (152cm) x 36" (91cm) x 32" (81cm) | 65" (165.1cm) x 35" (88.9cm) x 35" (88.9cm) |
| Weight (maximum) | 500 lbs (227 kg) | 650 lbs (295.46 kg) |
| Voltage (nominal) | 100/120/220/240 Single Phase | Same |
| Frequency | 50/60 Hz | Same |
| Source-Image receptor | ||
| distance | 17.5" (44cm) | Same |
| X-Ray Source | Grounded anode x-ray tube 0.005" (0.127 | |
| mm) Beryllium | Same | |
| Beam Filtration | Stainless Steel with Al equivalence > | |
| 2.5mm | Same | |
| Focal Spot | 0.0018" (0.045mm) @ 7.5 watts | Same |
| Field of View | Operator selectable, 4" or 6" collimation | |
| (10.16 cm or 15.24 cm) at plane of Image | ||
| Intensifier | Same | |
| Rated peak tube | ||
| potential | 75kVp | Same |
| Tube kVp range | 40 to 75kVp | Same |
| Tolerances | kVp ± 5% | |
| mA ± 8% ≤ 0.035mA | ||
| mA ± 5% ≥ 0.035mA | Same | |
| Maximum duty cycle | ||
| at 75 kVp/0.100mA | 50% | Same |
| Video Camera | Analog | Digital |
| System computer | 850 MHz processor | 2.4 GHz processor |
| minimum requirements | 128 MB RAM | 512 MB RAM |
| CD-ROM | Serial 80 GB HDD | |
| 20 GB HDD | DVD RAM drive | |
| 3.5" Floppy | 3.5" Floppy drive | |
| Operating System | Windows NT Embedded | Windows XP |
| Display | Dual 15" Hi-Res CRT | Medical grade 2 Mega Pixel 19.8" Monochrome |
| Flat LCD | ||
| Input Devices | Keyboard, Footswitch, Touch Screen | Same |
2
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird in the center. The text around the perimeter appears to be the name of a department or organization. The bird is depicted with three curved lines representing its body and wings, giving it a sense of motion. The logo has a simple, clean design, likely intended to represent the organization's values or mission.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 13 2005
Mr. Daniel F. Phelan Senior Regulatory Affairs Specialist HOLOGIC, Inc. 35 Crosby Drive BEDFORD MA 01730
Re: K051025
Trade/Device Name: Fluoroscan InSight Mini C-Arm Fluoroscopic Imaging System Regulation Number: 21 CFR §892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA r K Dated: April 21, 2005 Received: April 25, 2005
Dear Mr. Phelan:
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 application (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.
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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 r carrar states and regarding, but not limited to registration and listing (21 CFR Part 807); labeling / 21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ogin hances of substantial equivalence of your device to a legally premarket notification. The I Dri mailig of oation 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), please If you desire specific advice for your de restled in the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation entersely formation on your responsibilities under the Act from the 007.97). Tou may obtain outer general missance at its toll-free number (800) DIVISION of Stilan Manufactures, Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon
Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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A.2 Indications for Use Statement
510(k) Number (if known):K0510 25 ____________________________________________________________________________________________________________________________________________
Device Name: _Fluoroscan InSight Mini C-Arm Fluoroscopic Imaging System
Indications for Use:
The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System designed to provide physicians TTle Fluoroscan frisualization of a patient, including, but not limited to surgical orthopedic and with general hoorosopic visualization of a patient, wis and light anatomy imaging situations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter-Use
(Per 21 CFR 801.109)
(Optional Format 1)
Nancy Beaudoin
(Division Sign Division of Reproductive, Ab and Radiological Device 510(k) Number