(90 days)
No
The summary describes standard imaging techniques and reconstruction methods without mentioning AI or ML.
No.
The device is intended to produce images as diagnostic support, not for therapeutic purposes.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the system is intended to produce images "as diagnostic support".
No
The device description explicitly states it is an "X-ray unit" that "uses cone beam computed tomography (CBCT)" and produces images through physical processes, indicating it is a hardware device. While it uses software for reconstruction and viewing, the core device is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves analyzing blood, urine, tissue samples, or other bodily fluids or materials outside of the body.
- The Planmeca Viso is an imaging system. It produces images of anatomical structures within the patient's body using X-rays and optical imaging. It does not analyze biological specimens.
The intended use and device description clearly indicate that the Planmeca Viso is a medical imaging device used for diagnostic support by creating visual representations of internal structures. This falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Planmeca Viso is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital x-ray images as well as three-dimensional (3D) optical images of the dento-maxillo-facial, cervical spine and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
Product codes
OAS
Device Description
The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomies. Two dimensional (2D) images are produced with tomosynthesis method (panoramic) imaging) as well as conventional 2D radiography (cephalometric imaging, 2D views). In CBCT a cylindrical volume of data is captured in one imaging procedure. The data consists of several hundred sample images which are taken from different directions to cover a certain pre-programmed target area. These samples are used for 3D reconstruction (using a separate 3D reconstruction PC) that can be viewed in three dimensions using separate workstation and Planmeca Romexis software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cone beam computed tomography (CBCT), 2D radiography, 3D optical images
Anatomical Site
dento-maxillofacial, cervical spine and ENT (Ear, Nose, and Throat) regions
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
healthcare professionals
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)
Results from performance bench testing demonstrate that Planmeca Viso produces substantially equivalent image quality compared to the predicate and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized depiction of a human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
September 13, 2018
Planmeca Oy Lars Moring Regulatory Affairs Specialist Asentajankatu 6 FI-00880 Helsinki FINLAND
Re: K181576
Trade/Device Name: Planmeca Viso Regulation Number: 21 CFR 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: August 15, 2018 Received: August 17, 2018
Dear Lars Moring:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 contract 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Rodgers
Digitally signed by Jeffrey J. Ballyns -S DN· c=US o=US Government ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=20005697 25, cn=Jeffrey J. Ballyns -S Date: 2018.09.13 16:30:25 -04'00'
for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181576
Device Name Planmeca Viso
Indications for Use (Describe)
Planmeca Viso is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital x-ray images as well as three-dimensional (3D) optical images of the dento-maxillo-facial, cervical spine and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510K) SUMMARY
I. SUBMITTER
MANUFACTURER
Planmeca Oy Asentajankatu 6 FI-00880 Helsinki, Finland Phone: +358 20 7795 500 Contact person: Lars Moring
U.S. DESIGNATED AGENT
Planmeca USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: (630) 894 2300 Contact person : Bob Pienkowski
Date prepared: September 7, 2018
PRODUCT, CLASSIFICATION NAME II.
Name of the device: Common or Usual Name: Classification name: Requlatory Class: Product Code: 510(k) number:
Planmeca Viso Computed tomography x-ray system Computed tomography x-ray system (21 CFR 892.1750) -OAS #K181576
III. PREDICATE DEVICE
Planmeca ProMax 3D Max #K160506
IV. REFERENCE DEVICE
Planmeca ProMax 3D Mid #K103689 RAYSCAN A-EXPERT 3D, #K142247
V. DEVICE DESCRIPTION
The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomies. Two dimensional (2D) images are produced with tomosynthesis method (panoramic) imaging) as well as conventional 2D radiography (cephalometric imaging, 2D views). In CBCT a cylindrical volume of data is captured in one imaging procedure. The data consists of several hundred sample images which are taken from different directions to cover a certain pre-programmed target area. These samples are used for 3D reconstruction (using a separate 3D reconstruction PC) that can be viewed in three dimensions using separate workstation and Planmeca Romexis software.
VI. INDICATIONS FOR USE
Planmeca Viso is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital x-ray images as well as three-dimensional (3D) optical images of the dento-maxillofacial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
4
The Indications for Use (IFU) for the subject device are the same as those for the predicate device.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Both devices are 3D CBCT imaging system indicated for imaging dento-maxillofacial-, cervical spine- and ENT-regions and offer a variety of 3D fields of view suitable for each application. Both systems also provide 2D imaging capabilities, predicate device only for panoramic and Planmeca Viso both for panoramic and cephalometric imaging.
Both systems are based on fixed anode X-ray tube and a flat panel detector of the same technology. Pixel sizes of the detector differ but voxel sizes on resulting 3D images are the same." Tube voltage range with Planmeca Viso is wider and ranges up to 120kV, providing users with option to utilize even higher X-ray penetration when necessary.
| | Planmeca Viso | Predicate device Planmeca ProMax
3D Max |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Planmeca Viso is a system intended to
produce two-dimensional (2D) and
three-dimensional (3D) digital x-ray
images as well as three-dimensional
(3D) optical images of the dento-
maxillo-facial, cervical spine and ENT
(Ear, Nose, and Throat) regions at the
direction of healthcare professionals as
diagnostic support for pediatric and
adult patients. | The Planmeca ProMax 3D Max or
Maximity is a system intended produce
two-dimensional (2D) and three-
dimensional (3D) digital X-ray images o
the dento-maxillo-facial, cervical spine
and ENT (Ear, Nose and Throat)
regions at the direction of healthcare
professionals as diagnostic support for
pediatric and adult patients. |
| 3D Imaging | | |
| Technical
characteristics | • CBCT (cone beam computed
tomography)
• 300 - 600 projections over 210° / 360°
rotation
• Reconstruction time 30 s - 6 min
• Voxel size 75-600µm | • CBCT (cone beam computed
tomography)
• 300 - 600 projections over 210° / 360°
rotation
• Reconstruction time 30 s - 6 min
• Voxel size 75-600µm |
| Field Of View (FOV) | Ø30x30mm - Ø200x170mm (G5) /
Ø300x300mm (G7) | Ø42x48mm - Ø230x260mm |
| 2D Imaging | | |
| Technology | • SmartPan panoramic imaging,
tomosynthesis
• Multiview panoramic imaging,
tomosynthesis
• Cephalostat | • SmartPan panoramic imaging,
tomosynthesis
• Multiview panoramic imaging,
tomosynthesis
• No cephalostat |
| Imaging system
performance
specifications | | |
| X-ray detector | • Varex Imaging 16x16cm flat panel
(G5) / 25x30cm flat panel detector
(G7)
• aSi with Csl scintillator
• 127µm pixel pitch (G5) / 139µm pixel
pitch (G7)
• Bit depth 16bit
• Varian PaxScan 2530C
30.2(w)x24.9(h)cm
• GADOX scintillator | • Varex Imaging 25x20cm flat panel
detector
• aSi with Csl scintillator
• 127µm pixel pitch
• Bit depth 15bit |
Table 1: Comparison with predicate device
5
| X-ray tube and
| generator | ||
|---|---|---|
| • Fixed anode X-ray tube focal spot size 0.5 mm | ||
| • Tube voltage 60-120 kV | ||
| • Tube current 1-16 mA | ||
| • Exposure time 0.1–36 sec (pulsed) | • Fixed anode X-ray tube with 0.6mm focal spot | |
| • Tube voltage 66-96 kV | ||
| • Tube current 1-12,5 mA | ||
| • Exposure time 3–24 sec (pulsed) | ||
| Other | ||
| Workflow | • Open positioning, doctor facing the patient | |
| • Patient seated or standing | • Open positioning, doctor facing the patient | |
| • Patient seated or standing | ||
| Imaging Software | • Planmeca Romexis | • Planmeca Romexis |
Cephalometric scanning feature and detector are identical to those in previously cleared reference devices. The PaxScan 2530C, used for cephalometric imaging in the subject device, was included as a cephalometric detector in a previously cleared 510(k) for the RAYSCAN a-Expert 3D (K142247).
VIII. PERFORMANCE DATA
Results from performance bench testing demonstrate that Planmeca Viso produces substantially equivalent image quality compared to the predicate and reference devices.
IX. CONCLUSIONS
The comparison of characteristics supports substantial equivalence. Planmeca Viso is as safe and effective as the predicate device.